一苇生物科技-赋能临床研究计划和解决方案

药政法规

中华人民共和国药品管理法

1984 年9 月20 日第六届全国人民代表大会常务委员会第七次会议通过
2001 年2 月28 日第九届全国人民代表大会常务委员会第二十次会议第一次修订
根据2013 年12 月28 日第十二届全国人民代表大会常务委员会第六次会议《关于修改〈中华人民共和国海洋环境保护法〉等七部法律的决定》第一次修正
根据2015 年4 月24 日第十二届全国人民代表大会常务委员会第十四次会议《关于修改〈中华人民共和国药品管理法〉的决定》第二次修正
2019 年8 月26 日第十三届全国人民代表大会常务委员会第十二次会议第二次修订

第一章　总　　则

第一条　为了加强药品管理，保证药品质量，保障公众用药安全和合法权益，保护和促进公众健康，制定本法。
第二条　在中华人民共和国境内从事药品研制、生产、经营、使用和监督管理活动，适用本法。
本法所称药品，是指用于预防、治疗、诊断人的疾病，有目的地调节人的生理机能并规定有适应症或者功能主治、用法和用量的物质，包括中药、化学药和生物制品等。
第三条　药品管理应当以人民健康为中心，坚持风险管理、全程管控、社会共治的原则，建立科学、严格的监督管理制度，全面提升药品质量，保障药品的安全、有效、可及。
第四条　国家发展现代药和传统药，充分发挥其在预防、医疗和保健中的作用。
国家保护野生药材资源和中药品种，鼓励培育道地中药材。
第五条　国家鼓励研究和创制新药，保护公民、法人和其他组织研究、开发新药的合法权益。
第六条　国家对药品管理实行药品上市许可持有人制度。药品上市许可持有人依法对药品研制、生产、经营、使用全过程中药品的安全性、有效性和质量可控性负责。
第七条　从事药品研制、生产、经营、使用活动，应当遵守法律、法规、规章、标准和规范，保证全过程信息真实、准确、完整和可追溯。
第八条　国务院药品监督管理部门主管全国药品监督管理工作。国务院有关部门在各自职责范围内负责与药品有关的监督管理工作。国务院药品监督管理部门配合国务院有关部门，执行国家药品行业发展规划和产业政策。
省、自治区、直辖市人民政府药品监督管理部门负责本行政区域内的药品监督管理工作。设区的市级、县级人民政府承担药品监督管理职责的部门（以下称药品监督管理部门）负责本行政区域内的药品监督管理工作。县级以上地方人民政府有关部门在各自职责范围内负责与药品有关的监督管理工作。
第九条　县级以上地方人民政府对本行政区域内的药品监督管理工作负责，统一领导、组织、协调本行政区域内的药品监督管理工作以及药品安全突发事件应对工作，建立健全药品监督管理工作机制和信息共享机制。
第十条　县级以上人民政府应当将药品安全工作纳入本级国民经济和社会发展规划，将药品安全工作经费列入本级政府预算，加强药品监督管理能力建设，为药品安全工作提供保障。
第十一条　药品监督管理部门设置或者指定的药品专业技术机构，承担依法实施药品监督管理所需的审评、检验、核查、监测与评价等工作。
第十二条　国家建立健全药品追溯制度。国务院药品监督管理部门应当制定统一的药品追溯标准和规范，推进药品追溯信息互通互享，实现药品可追溯。
第十三条　各级人民政府及其有关部门、药品行业协会等应当加强药品安全宣传教育，开展药品安全法律法规等知识的普及工作。
新闻媒体应当开展药品安全法律法规等知识的公益宣传，并对药品违法行为进行舆论监督。有关药品的宣传报道应当全面、科学、客观、公正。
第十四条　药品行业协会应当加强行业自律，建立健全行业规范，推动行业诚信体系建设，引导和督促会员依法开展药品生产经营等活动。
第十五条　县级以上人民政府及其有关部门对在药品研制、生产、经营、使用和监督管理工作中做出突出贡献的单位和个人，按照国家有关规定给予表彰、奖励。

第二章药品研制和注册

第十六条　国家支持以临床价值为导向、对人的疾病具有明确或者特殊疗效的药物创新，鼓励具有新的治疗机理、治疗严重危及生命的疾病或者罕见病、对人体具有多靶向系统性调节干预功能等的新药研制，推动药品技术进步。
国家鼓励运用现代科学技术和传统中药研究方法开展中药科学技术研究和药物开发，建立和完善符合中药特点的技术评价体系，促进中药传承创新。
国家采取有效措施，鼓励儿童用药品的研制和创新，支持开发符合儿童生理特征的儿童用药品新品种、剂型和规格，对儿童用药品予以优先审评审批。
第十七条　从事药品研制活动，应当遵守药物非临床研究质量管理规范、药物临床试验质量管理规范，保证药品研制全过程持续符合法定要求。
药物非临床研究质量管理规范、药物临床试验质量管理规范由国务院药品监督管理部门会同国务院有关部门制定。
第十八条　开展药物非临床研究，应当符合国家有关规定，有与研究项目相适应的人员、场地、设备、仪器和管理制度，保证有关数据、资料和样品的真实性。
第十九条　开展药物临床试验，应当按照国务院药品监督管理部门的规定如实报送研制方法、质量指标、药理及毒理试验结果等有关数据、资料和样品，经国务院药品监督管理部门批准。国务院药品监督管理部门应当自受理临床试验申请之日起六十个工作日内决定是否同意并通知临床试验申办者，逾期未通知的，视为同意。其中，开展生物等效性试验的，报国务院药品监督管理部门备案。
开展药物临床试验，应当在具备相应条件的临床试验机构进行。药物临床试验机构实行备案管理，具体办法由国务院药品监督管理部门、国务院卫生健康主管部门共同制定。
第二十条　开展药物临床试验，应当符合伦理原则，制定临床试验方案，经伦理委员会审查同意。
伦理委员会应当建立伦理审查工作制度，保证伦理审查过程独立、客观、公正，监督规范开展药物临床试验，保障受试者合法权益，维护社会公共利益。
第二十一条　实施药物临床试验，应当向受试者或者其监护人如实说明和解释临床试验的目的和风险等详细情况，取得受试者或者其监护人自愿签署的知情同意书，并采取有效措施保护受试者合法权益。
第二十二条　药物临床试验期间，发现存在安全性问题或者其他风险的，临床试验申办者应当及时调整临床试验方案、暂停或者终止临床试验，并向国务院药品监督管理部门报告。必要时，国务院药品监督管理部门可以责令调整临床试验方案、暂停或者终止临床试验。
第二十三条　对正在开展临床试验的用于治疗严重危及生命且尚无有效治疗手段的疾病的药物，经医学观察可能获益，并且符合伦理原则的，经审查、知情同意后可以在开展临床试验的机构内用于其他病情相同的患者。
第二十四条　在中国境内上市的药品，应当经国务院药品监督管理部门批准，取得药品注册证书；但是，未实施审批管理的中药材和中药饮片除外。实施审批管理的中药材、中药饮片品种目录由国务院药品监督管理部门会同国务院中医药主管部门制定。
申请药品注册，应当提供真实、充分、可靠的数据、资料和样品，证明药品的安全性、有效性和质量可控性。
第二十五条　对申请注册的药品，国务院药品监督管理部门应当组织药学、医学和其他技术人员进行审评, 对药品的安全性、有效性和质量可控性以及申请人的质量管理、风险防控和责任赔偿等能力进行审查；符合条件的，颁发药品注册证书。
国务院药品监督管理部门在审批药品时，对化学原料药一并审评审批，对相关辅料、直接接触药品的包装材料和容器一并审评，对药品的质量标准、生产工艺、标签和说明书一并核准。
本法所称辅料，是指生产药品和调配处方时所用的赋形剂和附加剂。
第二十六条　对治疗严重危及生命且尚无有效治疗手段的疾病以及公共卫生方面急需的药品，药物临床试验已有数据显示疗效并能预测其临床价值的，可以附条件批准，并在药品注册证书中载明相关事项。
第二十七条　国务院药品监督管理部门应当完善药品审评审批工作制度，加强能力建设，建立健全沟通交流、专家咨询等机制，优化审评审批流程，提高审评审批效率。
批准上市药品的审评结论和依据应当依法公开，接受社会监督。对审评审批中知悉的商业秘密应当保密。
第二十八条　药品应当符合国家药品标准。经国务院药品监督管理部门核准的药品质量标准高于国家药品标准的，按照经核准的药品质量标准执行；没有国家药品标准的，应当符合经核准的药品质量标准。
国务院药品监督管理部门颁布的《中华人民共和国药典》和药品标准为国家药品标准。
国务院药品监督管理部门会同国务院卫生健康主管部门组织药典委员会，负责国家药品标准的制定和修订。
国务院药品监督管理部门设置或者指定的药品检验机构负责标定国家药品标准品、对照品。
第二十九条　列入国家药品标准的药品名称为药品通用名称。已经作为药品通用名称的，该名称不得作为药品商标使用。

第三章　药品上市许可持有人

第三十条　药品上市许可持有人是指取得药品注册证书的企业或者药品研制机构等。
药品上市许可持有人应当依照本法规定，对药品的非临床研究、临床试验、生产经营、上市后研究、不良反应监测及报告与处理等承担责任。其他从事药品研制、生产、经营、储存、运输、使用等活动的单位和个人依法承担相应责任。
药品上市许可持有人的法定代表人、主要负责人对药品质量全面负责。
第三十一条　药品上市许可持有人应当建立药品质量保证体系，配备专门人员独立负责药品质量管理。
药品上市许可持有人应当对受托药品生产企业、药品经营企业的质量管理体系进行定期审核，监督其持续具备质量保证和控制能力。
第三十二条　药品上市许可持有人可以自行生产药品，也可以委托药品生产企业生产。
药品上市许可持有人自行生产药品的，应当依照本法规定取得药品生产许可证；委托生产的，应当委托符合条件的药品生产企业。药品上市许可持有人和受托生产企业应当签订委托协议和质量协议，并严格履行协议约定的义务。
国务院药品监督管理部门制定药品委托生产质量协议指南，指导、监督药品上市许可持有人和受托生产企业履行药品质量保证义务。
血液制品、麻醉药品、精神药品、医疗用毒性药品、药品类易制毒化学品不得委托生产；但是，国务院药品监督管理部门另有规定的除外。
第三十三条　药品上市许可持有人应当建立药品上市放行规程，对药品生产企业出厂放行的药品进行审核，经质量受权人签字后方可放行。不符合国家药品标准的，不得放行。
第三十四条　药品上市许可持有人可以自行销售其取得药品注册证书的药品，也可以委托药品经营企业销售。药品上市许可持有人从事药品零售活动的，应当取得药品经营许可证。
药品上市许可持有人自行销售药品的，应当具备本法第五十二条规定的条件；委托销售的，应当委托符合条件的药品经营企业。药品上市许可持有人和受托经营企业应当签订委托协议，并严格履行协议约定的义务。
第三十五条　药品上市许可持有人、药品生产企业、药品经营企业委托储存、运输药品的，应当对受托方的质量保证能力和风险管理能力进行评估，与其签订委托协议，约定药品质量责任、操作规程等内容，并对受托方进行监督。
第三十六条　药品上市许可持有人、药品生产企业、药品经营企业和医疗机构应当建立并实施药品追溯制度，按照规定提供追溯信息，保证药品可追溯。
第三十七条　药品上市许可持有人应当建立年度报告制度，每年将药品生产销售、上市后研究、风险管理等情况按照规定向省、自治区、直辖市人民政府药品监督管理部门报告。
第三十八条　药品上市许可持有人为境外企业的，应当由其指定的在中国境内的企业法人履行药品上市许可持有人义务，与药品上市许可持有人承担连带责任。
第三十九条　中药饮片生产企业履行药品上市许可持有人的相关义务，对中药饮片生产、销售实行全过程管理，建立中药饮片追溯体系，保证中药饮片安全、有效、可追溯。
第四十条　经国务院药品监督管理部门批准，药品上市许可持有人可以转让药品上市许可。受让方应当具备保障药品安全性、有效性和质量可控性的质量管理、风险防控和责任赔偿等能力，履行药品上市许可持有人义务。

第四章　药品生产

第四十一条　从事药品生产活动，应当经所在地省、自治区、直辖市人民政府药品监督管理部门批准，取得药品生产许可证。无药品生产许可证的，不得生产药品。
药品生产许可证应当标明有效期和生产范围，到期重新审查发证。
第四十二条　从事药品生产活动，应当具备以下条件:
（一）有依法经过资格认定的药学技术人员、工程技术人员及相应的技术工人；
（二）有与药品生产相适应的厂房、设施和卫生环境；
（三）有能对所生产药品进行质量管理和质量检验的机构、人员及必要的仪器设备；
（四）有保证药品质量的规章制度，并符合国务院药品监督管理部门依据本法制定的药品生产质量管理规范要求。
第四十三条　从事药品生产活动，应当遵守药品生产质量管理规范，建立健全药品生产质量管理体系，保证药品生产全过程持续符合法定要求。
药品生产企业的法定代表人、主要负责人对本企业的药品生产活动全面负责。
第四十四条　药品应当按照国家药品标准和经药品监督管理部门核准的生产工艺进行生产。生产、检验记录应当完整准确，不得编造。
中药饮片应当按照国家药品标准炮制；国家药品标准没有规定的，应当按照省、自治区、直辖市人民政府药品监督管理部门制定的炮制规范炮制。省、自治区、直辖市人民政府药品监督管理部门制定的炮制规范应当报国务院药品监督管理部门备案。不符合国家药品标准或者不按照省、自治区、直辖市人民政府药品监督管理部门制定的炮制规范炮制的，不得出厂、销售。
第四十五条　生产药品所需的原料、辅料，应当符合药用要求、药品生产质量管理规范的有关要求。
生产药品，应当按照规定对供应原料、辅料等的供应商进行审核，保证购进、使用的原料、辅料等符合前款规定要求。
第四十六条　直接接触药品的包装材料和容器，应当符合药用要求，符合保障人体健康、安全的标准。
对不合格的直接接触药品的包装材料和容器，由药品监督管理部门责令停止使用。
第四十七条　药品生产企业应当对药品进行质量检验。不符合国家药品标准的，不得出厂。
药品生产企业应当建立药品出厂放行规程，明确出厂放行的标准、条件。符合标准、条件的，经质量受权人签字后方可放行。
第四十八条　药品包装应当适合药品质量的要求，方便储存、运输和医疗使用。
发运中药材应当有包装。在每件包装上，应当注明品名、产地、日期、供货单位，并附有质量合格的标志。
第四十九条　药品包装应当按照规定印有或者贴有标签并附有说明书。
标签或者说明书应当注明药品的通用名称、成份、规格、上市许可持有人及其地址、生产企业及其地址、批准文号、产品批号、生产日期、有效期、适应症或者功能主治、用法、用量、禁忌、不良反应和注意事项。标签、说明书中的文字应当清晰，生产日期、有效期等事项应当显著标注，容易辨识。
麻醉药品、精神药品、医疗用毒性药品、放射性药品、外用药品和非处方药的标签、说明书，应当印有规定的标志。
第五十条　药品上市许可持有人、药品生产企业、药品经营企业和医疗机构中直接接触药品的工作人员，应当每年进行健康检查。患有传染病或者其他可能污染药品的疾病的，不得从事直接接触药品的工作。

第五章　药品经营

第五十一条　从事药品批发活动，应当经所在地省、自治区、直辖市人民政府药品监督管理部门批准，取得药品经营许可证。从事药品零售活动，应当经所在地县级以上地方人民政府药品监督管理部门批准，取得药品经营许可证。无药品经营许可证的，不得经营药品。
药品经营许可证应当标明有效期和经营范围，到期重新审查发证。
药品监督管理部门实施药品经营许可，除依据本法第五十二条规定的条件外，还应当遵循方便群众购药的原则。
第五十二条　从事药品经营活动应当具备以下条件:
（一）有依法经过资格认定的药师或者其他药学技术人员；
（二）有与所经营药品相适应的营业场所、设备、仓储设施和卫生环境；
（三）有与所经营药品相适应的质量管理机构或者人员；
（四）有保证药品质量的规章制度，并符合国务院药品监督管理部门依据本法制定的药品经营质量管理规范要求。
第五十三条　从事药品经营活动，应当遵守药品经营质量管理规范，建立健全药品经营质量管理体系，保证药品经营全过程持续符合法定要求。
国家鼓励、引导药品零售连锁经营。从事药品零售连锁经营活动的企业总部，应当建立统一的质量管理制度，对所属零售企业的经营活动履行管理责任。
药品经营企业的法定代表人、主要负责人对本企业的药品经营活动全面负责。
第五十四条　国家对药品实行处方药与非处方药分类管理制度。具体办法由国务院药品监督管理部门会同国务院卫生健康主管部门制定。
第五十五条　药品上市许可持有人、药品生产企业、药品经营企业和医疗机构应当从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品；但是，购进未实施审批管理的中药材除外。
第五十六条　药品经营企业购进药品，应当建立并执行进货检查验收制度，验明药品合格证明和其他标识；不符合规定要求的，不得购进和销售。
第五十七条　药品经营企业购销药品，应当有真实、完整的购销记录。购销记录应当注明药品的通用名称、剂型、规格、产品批号、有效期、上市许可持有人、生产企业、购销单位、购销数量、购销价格、购销日期及国务院药品监督管理部门规定的其他内容。
第五十八条　药品经营企业零售药品应当准确无误，并正确说明用法、用量和注意事项；调配处方应当经过核对，对处方所列药品不得擅自更改或者代用。对有配伍禁忌或者超剂量的处方，应当拒绝调配；必要时，经处方医师更正或者重新签字，方可调配。
药品经营企业销售中药材，应当标明产地。
依法经过资格认定的药师或者其他药学技术人员负责本企业的药品管理、处方审核和调配、合理用药指导等工作。
第五十九条　药品经营企业应当制定和执行药品保管制度，采取必要的冷藏、防冻、防潮、防虫、防鼠等措施，保证药品质量。
药品入库和出库应当执行检查制度。
第六十条　城乡集市贸易市场可以出售中药材，国务院另有规定的除外。
第六十一条　药品上市许可持有人、药品经营企业通过网络销售药品，应当遵守本法药品经营的有关规定。具体管理办法由国务院药品监督管理部门会同国务院卫生健康主管部门等部门制定。
疫苗、血液制品、麻醉药品、精神药品、医疗用毒性药品、放射性药品、药品类易制毒化学品等国家实行特殊管理的药品不得在网络上销售。
第六十二条　药品网络交易第三方平台提供者应当按照国务院药品监督管理部门的规定，向所在地省、自治区、直辖市人民政府药品监督管理部门备案。
第三方平台提供者应当依法对申请进入平台经营的药品上市许可持有人、药品经营企业的资质等进行审核，保证其符合法定要求，并对发生在平台的药品经营行为进行管理。
第三方平台提供者发现进入平台经营的药品上市许可持有人、药品经营企业有违反本法规定行为的，应当及时制止并立即报告所在地县级人民政府药品监督管理部门；发现严重违法行为的，应当立即停止提供网络交易平台服务。
第六十三条　新发现和从境外引种的药材，经国务院药品监督管理部门批准后，方可销售。
第六十四条　药品应当从允许药品进口的口岸进口，并由进口药品的企业向口岸所在地药品监督管理部门备案。海关凭药品监督管理部门出具的进口药品通关单办理通关手续。无进口药品通关单的，海关不得放行。
口岸所在地药品监督管理部门应当通知药品检验机构按照国务院药品监督管理部门的规定对进口药品进行抽查检验。
允许药品进口的口岸由国务院药品监督管理部门会同海关总署提出，报国务院批准。
第六十五条　医疗机构因临床急需进口少量药品的，经国务院药品监督管理部门或者国务院授权的省、自治区、直辖市人民政府批准，可以进口。进口的药品应当在指定医疗机构内用于特定医疗目的。
个人自用携带入境少量药品，按照国家有关规定办理。
第六十六条　进口、出口麻醉药品和国家规定范围内的精神药品，应当持有国务院药品监督管理部门颁发的进口准许证、出口准许证。
第六十七条　禁止进口疗效不确切、不良反应大或者因其他原因危害人体健康的药品。
第六十八条　国务院药品监督管理部门对下列药品在销售前或者进口时，应当指定药品检验机构进行检验；未经检验或者检验不合格的，不得销售或者进口:
（一）首次在中国境内销售的药品；
（二）国务院药品监督管理部门规定的生物制品；
（三）国务院规定的其他药品。

第六章　医疗机构药事管理

第六十九条　医疗机构应当配备依法经过资格认定的药师或者其他药学技术人员，负责本单位的药品管理、处方审核和调配、合理用药指导等工作。非药学技术人员不得直接从事药剂技术工作。
第七十条　医疗机构购进药品，应当建立并执行进货检查验收制度，验明药品合格证明和其他标识；不符合规定要求的，不得购进和使用。
第七十一条　医疗机构应当有与所使用药品相适应的场所、设备、仓储设施和卫生环境，制定和执行药品保管制度，采取必要的冷藏、防冻、防潮、防虫、防鼠等措施，保证药品质量。
第七十二条　医疗机构应当坚持安全有效、经济合理的用药原则，遵循药品临床应用指导原则、临床诊疗指南和药品说明书等合理用药，对医师处方、用药医嘱的适宜性进行审核。
医疗机构以外的其他药品使用单位，应当遵守本法有关医疗机构使用药品的规定。
第七十三条　依法经过资格认定的药师或者其他药学技术人员调配处方，应当进行核对，对处方所列药品不得擅自更改或者代用。对有配伍禁忌或者超剂量的处方，应当拒绝调配；必要时，经处方医师更正或者重新签字，方可调配。
第七十四条　医疗机构配制制剂，应当经所在地省、自治区、直辖市人民政府药品监督管理部门批准，取得医疗机构制剂许可证。无医疗机构制剂许可证的，不得配制制剂。
医疗机构制剂许可证应当标明有效期，到期重新审查发证。
第七十五条　医疗机构配制制剂，应当有能够保证制剂质量的设施、管理制度、检验仪器和卫生环境。
医疗机构配制制剂，应当按照经核准的工艺进行，所需的原料、辅料和包装材料等应当符合药用要求。
第七十六条　医疗机构配制的制剂，应当是本单位临床需要而市场上没有供应的品种，并应当经所在地省、自治区、直辖市人民政府药品监督管理部门批准；但是，法律对配制中药制剂另有规定的除外。
医疗机构配制的制剂应当按照规定进行质量检验；合格的，凭医师处方在本单位使用。经国务院药品监督管理部门或者省、自治区、直辖市人民政府药品监督管理部门批准，医疗机构配制的制剂可以在指定的医疗机构之间调剂使用。
医疗机构配制的制剂不得在市场上销售。

第七章　药品上市后管理

第七十七条　药品上市许可持有人应当制定药品上市后风险管理计划，主动开展药品上市后研究，对药品的安全性、有效性和质量可控性进行进一步确证，加强对已上市药品的持续管理。
第七十八条　对附条件批准的药品，药品上市许可持有人应当采取相应风险管理措施，并在规定期限内按照要求完成相关研究；逾期未按照要求完成研究或者不能证明其获益大于风险的，国务院药品监督管理部门应当依法处理，直至注销药品注册证书。
第七十九条　对药品生产过程中的变更，按照其对药品安全性、有效性和质量可控性的风险和产生影响的程度，实行分类管理。属于重大变更的，应当经国务院药品监督管理部门批准，其他变更应当按照国务院药品监督管理部门的规定备案或者报告。
药品上市许可持有人应当按照国务院药品监督管理部门的规定，全面评估、验证变更事项对药品安全性、有效性和质量可控性的影响。
第八十一条　药品上市许可持有人、药品生产企业、药品经营企业和医疗机构应当经常考察本单位所生产、经营、使用的药品质量、疗效和不良反应。发现疑似不良反应的，应当及时向药品监督管理部门和卫生健康主管部门报告。具体办法由国务院药品监督管理部门会同国务院卫生健康主管部门制定。
对已确认发生严重不良反应的药品，由国务院药品监督管理部门或者省、自治区、直辖市人民政府药品监督管理部门根据实际情况采取停止生产、销售、使用等紧急控制措施，并应当在五日内组织鉴定，自鉴定结论作出之日起十五日内依法作出行政处理决定。
第八十二条　药品存在质量问题或者其他安全隐患的，药品上市许可持有人应当立即停止销售，告知相关药品经营企业和医疗机构停止销售和使用，召回已销售的药品，及时公开召回信息，必要时应当立即停止生产，并将药品召回和处理情况向省、自治区、直辖市人民政府药品监督管理部门和卫生健康主管部门报告。药品生产企业、药品经营企业和医疗机构应当配合。
药品上市许可持有人依法应当召回药品而未召回的，省、自治区、直辖市人民政府药品监督管理部门应当责令其召回。
第八十三条　药品上市许可持有人应当对已上市药品的安全性、有效性和质量可控性定期开展上市后评价。必要时，国务院药品监督管理部门可以责令药品上市许可持有人开展上市后评价或者直接组织开展上市后评价。
经评价，对疗效不确切、不良反应大或者因其他原因危害人体健康的药品，应当注销药品注册证书。
已被注销药品注册证书的药品，不得生产或者进口、销售和使用。
已被注销药品注册证书、超过有效期等的药品，应当由药品监督管理部门监督销毁或者依法采取其他无害化处理等措施。

第八章　药品价格和广告

第八十四条　国家完善药品采购管理制度，对药品价格进行监测，开展成本价格调查，加强药品价格监督检查，依法查处价格垄断、哄抬价格等药品价格违法行为，维护药品价格秩序。
第八十五条　依法实行市场调节价的药品，药品上市许可持有人、药品生产企业、药品经营企业和医疗机构应当按照公平、合理和诚实信用、质价相符的原则制定价格，为用药者提供价格合理的药品。
药品上市许可持有人、药品生产企业、药品经营企业和医疗机构应当遵守国务院药品价格主管部门关于药品价格管理的规定，制定和标明药品零售价格，禁止暴利、价格垄断和价格欺诈等行为。
第八十六条　药品上市许可持有人、药品生产企业、药品经营企业和医疗机构应当依法向药品价格主管部门提供其药品的实际购销价格和购销数量等资料。
第八十七条　医疗机构应当向患者提供所用药品的价格清单，按照规定如实公布其常用药品的价格，加强合理用药管理。具体办法由国务院卫生健康主管部门制定。
第八十八条　禁止药品上市许可持有人、药品生产企业、药品经营企业和医疗机构在药品购销中给予、收受回扣或者其他不正当利益。
禁止药品上市许可持有人、药品生产企业、药品经营企业或者代理人以任何名义给予使用其药品的医疗机构的负责人、药品采购人员、医师、药师等有关人员财物或者其他不正当利益。禁止医疗机构的负责人、药品采购人员、医师、药师等有关人员以任何名义收受药品上市许可持有人、药品生产企业、药品经营企业或者代理人给予的财物或者其他不正当利益。
第八十九条　药品广告应当经广告主所在地省、自治区、直辖市人民政府确定的广告审查机关批准；未经批准的，不得发布。
第九十条　药品广告的内容应当真实、合法，以国务院药品监督管理部门核准的药品说明书为准，不得含有虚假的内容。
药品广告不得含有表示功效、安全性的断言或者保证；不得利用国家机关、科研单位、学术机构、行业协会或者专家、学者、医师、药师、患者等的名义或者形象作推荐、证明。
非药品广告不得有涉及药品的宣传。
第九十一条　药品价格和广告，本法未作规定的，适用《中华人民共和国价格法》、《中华人民共和国反垄断法》、《中华人民共和国反不正当竞争法》、《中华人民共和国广告法》等的规定。

第九章　药品储备和供应

第九十二条　国家实行药品储备制度，建立中央和地方两级药品储备。
发生重大灾情、疫情或者其他突发事件时，依照《中华人民共和国突发事件应对法》的规定，可以紧急调用药品。
第九十三条　国家实行基本药物制度，遴选适当数量的基本药物品种，加强组织生产和储备，提高基本药物的供给能力，满足疾病防治基本用药需求。
第九十四条　国家建立药品供求监测体系，及时收集和汇总分析短缺药品供求信息，对短缺药品实行预警，采取应对措施。
第九十五条　国家实行短缺药品清单管理制度。具体办法由国务院卫生健康主管部门会同国务院药品监督管理部门等部门制定。
药品上市许可持有人停止生产短缺药品的，应当按照规定向国务院药品监督管理部门或者省、自治区、直辖市人民政府药品监督管理部门报告。
第九十六条　国家鼓励短缺药品的研制和生产，对临床急需的短缺药品、防治重大传染病和罕见病等疾病的新药予以优先审评审批。
第九十七条　对短缺药品，国务院可以限制或者禁止出口。必要时，国务院有关部门可以采取组织生产、价格干预和扩大进口等措施，保障药品供应。
药品上市许可持有人、药品生产企业、药品经营企业应当按照规定保障药品的生产和供应。

第十章　监督管理

第九十八条　禁止生产（包括配制，下同）、销售、使用假药、劣药。
有下列情形之一的，为假药:
（一）药品所含成份与国家药品标准规定的成份不符；
（二）以非药品冒充药品或者以他种药品冒充此种药品；
（三）变质的药品；
（四）药品所标明的适应症或者功能主治超出规定范围。
有下列情形之一的，为劣药：
（一）药品成份的含量不符合国家药品标准；
（二）被污染的药品；
（三）未标明或者更改有效期的药品；
（四）未注明或者更改产品批号的药品；
（五）超过有效期的药品；
（六）擅自添加防腐剂、辅料的药品；
（七）其他不符合药品标准的药品。
禁止未取得药品批准证明文件生产、进口药品；禁止使用未按照规定审评、审批的原料药、包装材料和容器生产药品。
第九十九条　药品监督管理部门应当依照法律、法规的规定对药品研制、生产、经营和药品使用单位使用药品等活动进行监督检查，必要时可以对为药品研制、生产、经营、使用提供产品或者服务的单位和个人进行延伸检查，有关单位和个人应当予以配合，不得拒绝和隐瞒。
药品监督管理部门应当对高风险的药品实施重点监督检查。
对有证据证明可能存在安全隐患的，药品监督管理部门根据监督检查情况，应当采取告诫、约谈、限期整改以及暂停生产、销售、使用、进口等措施，并及时公布检查处理结果。
药品监督管理部门进行监督检查时，应当出示证明文件，对监督检查中知悉的商业秘密应当保密。
第一百条　药品监督管理部门根据监督管理的需要，可以对药品质量进行抽查检验。抽查检验应当按照规定抽样，并不得收取任何费用；抽样应当购买样品。所需费用按照国务院规定列支。
对有证据证明可能危害人体健康的药品及其有关材料，药品监督管理部门可以查封、扣押，并在七日内作出行政处理决定；药品需要检验的，应当自检验报告书发出之日起十五日内作出行政处理决定。
第一百零一条　国务院和省、自治区、直辖市人民政府的药品监督管理部门应当定期公告药品质量抽查检验结果；公告不当的，应当在原公告范围内予以更正。
第一百零二条　当事人对药品检验结果有异议的，可以自收到药品检验结果之日起七日内向原药品检验机构或者上一级药品监督管理部门设置或者指定的药品检验机构申请复验，也可以直接向国务院药品监督管理部门设置或者指定的药品检验机构申请复验。受理复验的药品检验机构应当在国务院药品监督管理部门规定的时间内作出复验结论。
第一百零三条　药品监督管理部门应当对药品上市许可持有人、药品生产企业、药品经营企业和药物非临床安全性评价研究机构、药物临床试验机构等遵守药品生产质量管理规范、药品经营质量管理规范、药物非临床研究质量管理规范、药物临床试验质量管理规范等情况进行检查，监督其持续符合法定要求。
第一百零四条　国家建立职业化、专业化药品检查员队伍。检查员应当熟悉药品法律法规，具备药品专业知识。
第一百零五条　药品监督管理部门建立药品上市许可持有人、药品生产企业、药品经营企业、药物非临床安全性评价研究机构、药物临床试验机构和医疗机构药品安全信用档案，记录许可颁发、日常监督检查结果、违法行为查处等情况，依法向社会公布并及时更新；对有不良信用记录的，增加监督检查频次，并可以按照国家规定实施联合惩戒。
第一百零六条　药品监督管理部门应当公布本部门的电子邮件地址、电话，接受咨询、投诉、举报，并依法及时答复、核实、处理。对查证属实的举报，按照有关规定给予举报人奖励。
药品监督管理部门应当对举报人的信息予以保密，保护举报人的合法权益。举报人举报所在单位的，该单位不得以解除、变更劳动合同或者其他方式对举报人进行打击报复。
第一百零七条　国家实行药品安全信息统一公布制度。国家药品安全总体情况、药品安全风险警示信息、重大药品安全事件及其调查处理信息和国务院确定需要统一公布的其他信息由国务院药品监督管理部门统一公布。药品安全风险警示信息和重大药品安全事件及其调查处理信息的影响限于特定区域的，也可以由有关省、自治区、直辖市人民政府药品监督管理部门公布。未经授权不得发布上述信息。
公布药品安全信息，应当及时、准确、全面，并进行必要的说明，避免误导。
任何单位和个人不得编造、散布虚假药品安全信息。
第一百零八条　县级以上人民政府应当制定药品安全事件应急预案。药品上市许可持有人、药品生产企业、药品经营企业和医疗机构等应当制定本单位的药品安全事件处置方案，并组织开展培训和应急演练。
发生药品安全事件，县级以上人民政府应当按照应急预案立即组织开展应对工作；有关单位应当立即采取有效措施进行处置，防止危害扩大。
第一百零九条　药品监督管理部门未及时发现药品安全系统性风险，未及时消除监督管理区域内药品安全隐患的，本级人民政府或者上级人民政府药品监督管理部门应当对其主要负责人进行约谈。
地方人民政府未履行药品安全职责，未及时消除区域性重大药品安全隐患的，上级人民政府或者上级人民政府药品监督管理部门应当对其主要负责人进行约谈。
被约谈的部门和地方人民政府应当立即采取措施，对药品监督管理工作进行整改。
约谈情况和整改情况应当纳入有关部门和地方人民政府药品监督管理工作评议、考核记录。
第一百一十条　地方人民政府及其药品监督管理部门不得以要求实施药品检验、审批等手段限制或者排斥非本地区药品上市许可持有人、药品生产企业生产的药品进入本地区。
第一百一十一条　药品监督管理部门及其设置或者指定的药品专业技术机构不得参与药品生产经营活动，不得以其名义推荐或者监制、监销药品。
药品监督管理部门及其设置或者指定的药品专业技术机构的工作人员不得参与药品生产经营活动。
第一百一十二条　国务院对麻醉药品、精神药品、医疗用毒性药品、放射性药品、药品类易制毒化学品等有其他特殊管理规定的，依照其规定。
第一百一十三条　药品监督管理部门发现药品违法行为涉嫌犯罪的，应当及时将案件移送公安机关。
对依法不需要追究刑事责任或者免予刑事处罚，但应当追究行政责任的，公安机关、人民检察院、人民法院应当及时将案件移送药品监督管理部门。
公安机关、人民检察院、人民法院商请药品监督管理部门、生态环境主管部门等部门提供检验结论、认定意见以及对涉案药品进行无害化处理等协助的，有关部门应当及时提供，予以协助。

第十一章　法律责任
第一百一十四条　违反本法规定，构成犯罪的，依法追究刑事责任。
第一百一十五条　未取得药品生产许可证、药品经营许可证或者医疗机构制剂许可证生产、销售药品的，责令关闭，没收违法生产、销售的药品和违法所得，并处违法生产、销售的药品（包括已售出和未售出的药品，下同）货值金额十五倍以上三十倍以下的罚款；货值金额不足十万元的，按十万元计算。
第一百一十六条　生产、销售假药的，没收违法生产、销售的药品和违法所得，责令停产停业整顿，吊销药品批准证明文件，并处违法生产、销售的药品货值金额十五倍以上三十倍以下的罚款；货值金额不足十万元的，按十万元计算；情节严重的，吊销药品生产许可证、药品经营许可证或者医疗机构制剂许可证，十年内不受理其相应申请；药品上市许可持有人为境外企业的，十年内禁止其药品进口。
第一百一十七条　生产、销售劣药的，没收违法生产、销售的药品和违法所得，并处违法生产、销售的药品货值金额十倍以上二十倍以下的罚款；违法生产、批发的药品货值金额不足十万元的，按十万元计算，违法零售的药品货值金额不足一万元的，按一万元计算；情节严重的，责令停产停业整顿直至吊销药品批准证明文件、药品生产许可证、药品经营许可证或者医疗机构制剂许可证。
生产、销售的中药饮片不符合药品标准，尚不影响安全性、有效性的，责令限期改正，给予警告；可以处十万元以上五十万元以下的罚款。
第一百一十八条　生产、销售假药，或者生产、销售劣药且情节严重的，对法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入百分之三十以上三倍以下的罚款，终身禁止从事药品生产经营活动，并可以由公安机关处五日以上十五日以下的拘留。
对生产者专门用于生产假药、劣药的原料、辅料、包装材料、生产设备予以没收。
第一百一十九条　药品使用单位使用假药、劣药的，按照销售假药、零售劣药的规定处罚；情节严重的，法定代表人、主要负责人、直接负责的主管人员和其他责任人员有医疗卫生人员执业证书的，还应当吊销执业证书。
第一百二十条　知道或者应当知道属于假药、劣药或者本法第一百二十四条第一款第一项至第五项规定的药品，而为其提供储存、运输等便利条件的，没收全部储存、运输收入，并处违法收入一倍以上五倍以下的罚款；情节严重的，并处违法收入五倍以上十五倍以下的罚款；违法收入不足五万元的，按五万元计算。
第一百二十一条　对假药、劣药的处罚决定，应当依法载明药品检验机构的质量检验结论。
第一百二十二条　伪造、变造、出租、出借、非法买卖许可证或者药品批准证明文件的，没收违法所得，并处违法所得一倍以上五倍以下的罚款；情节严重的，并处违法所得五倍以上十五倍以下的罚款，吊销药品生产许可证、药品经营许可证、医疗机构制剂许可证或者药品批准证明文件，对法定代表人、主要负责人、直接负责的主管人员和其他责任人员，处二万元以上二十万元以下的罚款，十年内禁止从事药品生产经营活动，并可以由公安机关处五日以上十五日以下的拘留；违法所得不足十万元的，按十万元计算。
第一百二十三条　提供虚假的证明、数据、资料、样品或者采取其他手段骗取临床试验许可、药品生产许可、药品经营许可、医疗机构制剂许可或者药品注册等许可的，撤销相关许可，十年内不受理其相应申请，并处五十万元以上五百万元以下的罚款；情节严重的，对法定代表人、主要负责人、直接负责的主管人员和其他责任人员，处二万元以上二十万元以下的罚款，十年内禁止从事药品生产经营活动，并可以由公安机关处五日以上十五日以下的拘留。
第一百二十四条　违反本法规定，有下列行为之一的，没收违法生产、进口、销售的药品和违法所得以及专门用于违法生产的原料、辅料、包装材料和生产设备，责令停产停业整顿，并处违法生产、进口、销售的药品货值金额十五倍以上三十倍以下的罚款；货值金额不足十万元的，按十万元计算；情节严重的，吊销药品批准证明文件直至吊销药品生产许可证、药品经营许可证或者医疗机构制剂许可证，对法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入百分之三十以上三倍以下的罚款，十年直至终身禁止从事药品生产经营活动，并可以由公安机关处五日以上十五日以下的拘留：
（一）未取得药品批准证明文件生产、进口药品；
（二）使用采取欺骗手段取得的药品批准证明文件生产、进口药品；
（三）使用未经审评审批的原料药生产药品；
（四）应当检验而未经检验即销售药品；
（五）生产、销售国务院药品监督管理部门禁止使用的药品；
（六）编造生产、检验记录；
（七）未经批准在药品生产过程中进行重大变更。
销售前款第一项至第三项规定的药品，或者药品使用单位使用前款第一项至第五项规定的药品的，依照前款规定处罚；情节严重的，药品使用单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员有医疗卫生人员执业证书的，还应当吊销执业证书。
未经批准进口少量境外已合法上市的药品，情节较轻的，可以依法减轻或者免予处罚。
第一百二十五条　违反本法规定，有下列行为之一的，没收违法生产、销售的药品和违法所得以及包装材料、容器，责令停产停业整顿，并处五十万元以上五百万元以下的罚款；情节严重的，吊销药品批准证明文件、药品生产许可证、药品经营许可证，对法定代表人、主要负责人、直接负责的主管人员和其他责任人员处二万元以上二十万元以下的罚款，十年直至终身禁止从事药品生产经营活动：（一）未经批准开展药物临床试验；
（二）使用未经审评的直接接触药品的包装材料或者容器生产药品，或者销售该类药品；
（三）使用未经核准的标签、说明书。
第一百二十六条　除本法另有规定的情形外，药品上市许可持有人、药品生产企业、药品经营企业、药物非临床安全性评价研究机构、药物临床试验机构等未遵守药品生产质量管理规范、药品经营质量管理规范、药物非临床研究质量管理规范、药物临床试验质量管理规范等的，责令限期改正，给予警告；逾期不改正的，处十万元以上五十万元以下的罚款；情节严重的，处五十万元以上二百万元以下的罚款，责令停产停业整顿直至吊销药品批准证明文件、药品生产许可证、药品经营许可证等，药物非临床安全性评价研究机构、药物临床试验机构等五年内不得开展药物非临床安全性评价研究、药物临床试验，对法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入百分之十以上百分之五十以下的罚款，十年直至终身禁止从事药品生产经营等活动。
第一百二十七条　违反本法规定，有下列行为之一的，责令限期改正，给予警告；逾期不改正的，处十万元以上五十万元以下的罚款：
（一）开展生物等效性试验未备案；
（二）药物临床试验期间，发现存在安全性问题或者其他风险，临床试验申办者未及时调整临床试验方案、暂停或者终止临床试验，或者未向国务院药品监督管理部门报告；
（三）未按照规定建立并实施药品追溯制度；
（四）未按照规定提交年度报告；
（五）未按照规定对药品生产过程中的变更进行备案或者报告；
（六）未制定药品上市后风险管理计划；
（七）未按照规定开展药品上市后研究或者上市后评价。
第一百二十八条　除依法应当按照假药、劣药处罚的外，药品包装未按照规定印有、贴有标签或者附有说明书，标签、说明书未按照规定注明相关信息或者印有规定标志的，责令改正，给予警告；情节严重的，吊销药品注册证书。
第一百二十九条　违反本法规定，药品上市许可持有人、药品生产企业、药品经营企业或者医疗机构未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品的，责令改正，没收违法购进的药品和违法所得，并处违法购进药品货值金额二倍以上十倍以下的罚款；情节严重的，并处货值金额十倍以上三十倍以下的罚款，吊销药品批准证明文件、药品生产许可证、药品经营许可证或者医疗机构执业许可证；货值金额不足五万元的，按五万元计算。
第一百三十条　违反本法规定，药品经营企业购销药品未按照规定进行记录，零售药品未正确说明用法、用量等事项，或者未按照规定调配处方的，责令改正，给予警告；情节严重的，吊销药品经营许可证。
第一百三十一条　违反本法规定，药品网络交易第三方平台提供者未履行资质审核、报告、停止提供网络交易平台服务等义务的，责令改正，没收违法所得，并处二十万元以上二百万元以下的罚款；情节严重的，责令停业整顿，并处二百万元以上五百万元以下的罚款。
第一百三十二条　进口已获得药品注册证书的药品，未按照规定向允许药品进口的口岸所在地药品监督管理部门备案的，责令限期改正，给予警告；逾期不改正的，吊销药品注册证书。
第一百三十三条　违反本法规定，医疗机构将其配制的制剂在市场上销售的，责令改正，没收违法销售的制剂和违法所得，并处违法销售制剂货值金额二倍以上五倍以下的罚款；情节严重的，并处货值金额五倍以上十五倍以下的罚款；货值金额不足五万元的，按五万元计算。
第一百三十四条　药品上市许可持有人未按照规定开展药品不良反应监测或者报告疑似药品不良反应的，责令限期改正，给予警告；逾期不改正的，责令停产停业整顿，并处十万元以上一百万元以下的罚款。
药品经营企业未按照规定报告疑似药品不良反应的，责令限期改正，给予警告；逾期不改正的，责令停产停业整顿，并处五万元以上五十万元以下的罚款。
医疗机构未按照规定报告疑似药品不良反应的，责令限期改正，给予警告；逾期不改正的，处五万元以上五十万元以下的罚款。
第一百三十五条　药品上市许可持有人在省、自治区、直辖市人民政府药品监督管理部门责令其召回后，拒不召回的，处应召回药品货值金额五倍以上十倍以下的罚款；货值金额不足十万元的，按十万元计算；情节严重的，吊销药品批准证明文件、药品生产许可证、药品经营许可证，对法定代表人、主要负责人、直接负责的主管人员和其他责任人员，处二万元以上二十万元以下的罚款。药品生产企业、药品经营企业、医疗机构拒不配合召回的，处十万元以上五十万元以下的罚款。
第一百三十六条　药品上市许可持有人为境外企业的，其指定的在中国境内的企业法人未依照本法规定履行相关义务的，适用本法有关药品上市许可持有人法律责任的规定。
第一百三十七条　有下列行为之一的，在本法规定的处罚幅度内从重处罚：
（一）以麻醉药品、精神药品、医疗用毒性药品、放射性药品、药品类易制毒化学品冒充其他药品，或者以其他药品冒充上述药品；
（二）生产、销售以孕产妇、儿童为主要使用对象的假药、劣药；
（三）生产、销售的生物制品属于假药、劣药；
（四）生产、销售假药、劣药，造成人身伤害后果；
（五）生产、销售假药、劣药，经处理后再犯；
（六）拒绝、逃避监督检查，伪造、销毁、隐匿有关证据材料，或者擅自动用查封、扣押物品。
第一百三十八条　药品检验机构出具虚假检验报告的，责令改正，给予警告，对单位并处二十万元以上一百万元以下的罚款；对直接负责的主管人员和其他直接责任人员依法给予降级、撤职、开除处分，没收违法所得，并处五万元以下的罚款；情节严重的，撤销其检验资格。药品检验机构出具的检验结果不实，造成损失的，应当承担相应的赔偿责任。
第一百三十九条　本法第一百一十五条至第一百三十八条规定的行政处罚，由县级以上人民政府药品监督管理部门按照职责分工决定；撤销许可、吊销许可证件的，由原批准、发证的部门决定。
第一百四十条　药品上市许可持有人、药品生产企业、药品经营企业或者医疗机构违反本法规定聘用人员的，由药品监督管理部门或者卫生健康主管部门责令解聘，处五万元以上二十万元以下的罚款。
第一百四十一条　药品上市许可持有人、药品生产企业、药品经营企业或者医疗机构在药品购销中给予、收受回扣或者其他不正当利益的，药品上市许可持有人、药品生产企业、药品经营企业或者代理人给予使用其药品的医疗机构的负责人、药品采购人员、医师、药师等有关人员财物或者其他不正当利益的，由市场监督管理部门没收违法所得，并处三十万元以上三百万元以下的罚款；情节严重的，吊销药品上市许可持有人、药品生产企业、药品经营企业营业执照，并由药品监督管理部门吊销药品批准证明文件、药品生产许可证、药品经营许可证。
药品上市许可持有人、药品生产企业、药品经营企业在药品研制、生产、经营中向国家工作人员行贿的，对法定代表人、主要负责人、直接负责的主管人员和其他责任人员终身禁止从事药品生产经营活动。
第一百四十二条　药品上市许可持有人、药品生产企业、药品经营企业的负责人、采购人员等有关人员在药品购销中收受其他药品上市许可持有人、药品生产企业、药品经营企业或者代理人给予的财物或者其他不正当利益的，没收违法所得，依法给予处罚；情节严重的，五年内禁止从事药品生产经营活动。
医疗机构的负责人、药品采购人员、医师、药师等有关人员收受药品上市许可持有人、药品生产企业、药品经营企业或者代理人给予的财物或者其他不正当利益的，由卫生健康主管部门或者本单位给予处分，没收违法所得；情节严重的，还应当吊销其执业证书。
第一百四十三条　违反本法规定，编造、散布虚假药品安全信息，构成违反治安管理行为的，由公安机关依法给予治安管理处罚。
第一百四十四条　药品上市许可持有人、药品生产企业、药品经营企业或者医疗机构违反本法规定，给用药者造成损害的，依法承担赔偿责任。
因药品质量问题受到损害的，受害人可以向药品上市许可持有人、药品生产企业请求赔偿损失，也可以向药品经营企业、医疗机构请求赔偿损失。接到受害人赔偿请求的，应当实行首负责任制，先行赔付；先行赔付后，可以依法追偿。
生产假药、劣药或者明知是假药、劣药仍然销售、使用的，受害人或者其近亲属除请求赔偿损失外，还可以请求支付价款十倍或者损失三倍的赔偿金；增加赔偿的金额不足一千元的，为一千元。
第一百四十五条　药品监督管理部门或者其设置、指定的药品专业技术机构参与药品生产经营活动的，由其上级主管机关责令改正，没收违法收入；情节严重的，对直接负责的主管人员和其他直接责任人员依法给予处分。
药品监督管理部门或者其设置、指定的药品专业技术机构的工作人员参与药品生产经营活动的，依法给予处分。
第一百四十六条　药品监督管理部门或者其设置、指定的药品检验机构在药品监督检验中违法收取检验费用的，由政府有关部门责令退还，对直接负责的主管人员和其他直接责任人员依法给予处分；情节严重的，撤销其检验资格。
第一百四十七条　违反本法规定，药品监督管理部门有下列行为之一的，应当撤销相关许可，对直接负责的主管人员和其他直接责任人员依法给予处分：
（一）不符合条件而批准进行药物临床试验；
（二）对不符合条件的药品颁发药品注册证书；
（三）对不符合条件的单位颁发药品生产许可证、药品经营许可证或者医疗机构制剂许可证。
第一百四十八条　违反本法规定，县级以上地方人民政府有下列行为之一的，对直接负责的主管人员和其他直接责任人员给予记过或者记大过处分；情节严重的，给予降级、撤职或者开除处分：
（一）瞒报、谎报、缓报、漏报药品安全事件；
（二）未及时消除区域性重大药品安全隐患，造成本行政区域内发生特别重大药品安全事件，或者连续发生重大药品安全事件；
（三）履行职责不力，造成严重不良影响或者重大损失。
第一百四十九条　违反本法规定，药品监督管理等部门有下列行为之一的，对直接负责的主管人员和其他直接责任人员给予记过或者记大过处分；情节较重的，给予降级或者撤职处分；情节严重的，给予开除处分：
（一）瞒报、谎报、缓报、漏报药品安全事件；
（二）对发现的药品安全违法行为未及时查处；
（三）未及时发现药品安全系统性风险，或者未及时消除监督管理区域内药品安全隐患，造成严重影响；
（四）其他不履行药品监督管理职责，造成严重不良影响或者重大损失。
第一百五十条　药品监督管理人员滥用职权、徇私舞弊、玩忽职守的，依法给予处分。
查处假药、劣药违法行为有失职、渎职行为的，对药品监督管理部门直接负责的主管人员和其他直接责任人员依法从重给予处分。
第一百五十一条　本章规定的货值金额以违法生产、销售药品的标价计算；没有标价的，按照同类药品的市场价格计算。

第十二章　附　　则

第一百五十二条　中药材种植、采集和饲养的管理，依照有关法律、法规的规定执行。
第一百五十三条　地区性民间习用药材的管理办法，由国务院药品监督管理部门会同国务院中医药主管部门制定。
第一百五十四条　中国人民解放军和中国人民武装警察部队执行本法的具体办法，由国务院、中央军事委员会依据本法制定。
第一百五十五条　本法自2019 年12 月1 日起施行。

第一章　总　　则
第二章　药品研制和注册
第三章　药品上市许可持有人
第四章　药品生产
第五章　药品经营
第六章　医疗机构药事管理
第七章　药品上市后管理
第八章　药品价格和广告
第九章　药品储备和供应
第十章　监督管理
第十一章　法律责任
第十二章　附　　则

Pharmaceutical regulations

Eway Biotech - Empowering Clinical trial Strategies and Solutions

Drug Administration Law of the People's Republicof China (2019 Revision)

Passed by the Seventh Session of the StandingCommittee of the Sixth National People's Congress on 20 September 1984
First amendment by the Twentieth Session ofthe Standing Committee of the Ninth National People's Congress on 28 February 2001
First revision on 28 December 2013 pursuantto the Decision of the Standing Committee of the National People's Congress on Revisionof Seven Pieces of Legislation Including the "Marine Environmental ProtectionLaw of the People's Republic of China" passed by the Sixth Session of the StandingCommittee of the Twelfth National People's Congress
Second revision on 24 April 2015 pursuant tothe Decision on Revision of the "Drug Administration Law of the People's Republicof China" passed by the Fourteenth Session of the Standing Committee of theTwelfth National People's Congress
Second amendment by the Twelfth Session of theStanding Committee of the Thirteenth National People's Congress on 26 August 2019

Chapter 1 General Principles

Article 1 This Law is enacted for the purposesof strengthening drug administration, to ensure drug quality, protecting the public'smedication safety and legitimate rights and interests, protecting and promotingpublic health.
Article 2 This Law shall apply to drug researchand development, manufacturing, distribution and use in the People's Republic ofChina and the supervision and administration activities thereof.
Drugs referred to in the Law shall mean substancesused for the prevention, treatment and diagnosis of human diseases and intendedfor the regulation of the physiological functions of human beings, for which indication,usage and dosage are stipulated, including traditional Chinese medicine, chemicalmedicine and biological products etc.
Article 3 Drug administration shall focus onpublic health, adhere to the principle of "risk management, whole process supervision,and social co-governance", establish a scientific and strict supervision andadministration system, comprehensively improve drug quality, and ensure drug safety,efficacy and accessibility of drugs.
Article 4 The State develops both modern medicinesand traditional medicines, to give full play to their role in prevention and treatmentof diseases and in the health care.
The State protects wild crud drugs and traditionalChinese medicine resources and encourages cultivation of genuine Chinese herbalmedicine.
Article 5 The State encourages research anddevelopment of new drugs, and protects the legitimate rights and interests of citizens,legal persons and other organizations in research and development of new drugs.
Article 6 The State implements marketing authorizationholder system for drug administration. Drug marketing authorization holders shallbe responsible pursuant to the law for drug safety, efficacy and quality controllabilitythroughout the drug research and development, manufacturing, distribution and useprocess.
Article 7 The conduct of drug research and development,manufacturing, distribution, and use, shall comply with applicable laws, regulations,standards and practices, to ensure the authenticity, accuracy, integrity and traceabilityof the whole-process data.
Article 8 The drug administrative departmentunder the State Council presides over the supervision and administration of drugsthroughout the country. The relevant departments under the State Council are responsiblefor supervision and administration related to drug within their respective responsibilities.The drug administrative department under the State Council cooperates with the relevantdepartments under the State Council to implement the drug industry development plansand industrial policies developed by the state.
The drug regulatory authorities of the people’sgovernment of a province, an autonomous region, or a municipality directly underthe Central Government shall undertake the drug supervision and administration withinits administrative region. The department in charge of drug regulation under thepeople’s governments of a city or county that sets districts (hereinafter referredto as the "drug administrative department") shall be responsible for thedrug supervision and administration within its administrative region. The relevantdepartments under the local people’s governments at o r above the county level shallbe responsible for supervision and administration related to drug within their respectiveresponsibilities.
Article 9 The local people's governments ator above the county level shall be responsible for the work of drug supervisionand administration within their respective administrative regions. They shall lead,organize, and coordinate the work of drug supervision and administration withintheir respective administrative regions as well as response to drug safety emergency.They shall establish and improve the work mechanism of drug supervision and administration,and the information sharing system.
Article 10 The people's governments at or abovethe county level shall incorporate the work of drug safety into the plans for theeconomic and social development of the people at the corresponding levels, and includefunds for drug safety in their government budgets, strengthen the capacity-buildingof drug supervision, and provide safeguards for drug safety work.
Article 11 Professional drug technology institutionsestablished or designated by drug regulatory departments perform review, testing,inspection, monitoring and evaluation as required by the conduct of drug supervisionand administration according to law.
Article 12 The State establishes and improvesupon a drug traceability system. The drug administrative department of the StateCouncil shall formulate unified drug traceability standards and regulations, propelmutual communication and sharing of drug traceability information, to achieve drugtraceability.
The State establishes a pharmacovigilance systemto monitor, identify, evaluate and control adverse reactions or other adverse reactionsrelated to drug usage drug.
Article 13 The people's governments at all levelsshall strengthen the publicity and education of drug safety, and carry out the popularizationof knowledge on laws and regulations of drug safety.
The new media shall publicize knowledge on relevantlaws and regulations of drugs, and supervise unlawful acts concerning drugs by publicopinions. The publicity and reporting about drugs shall be comprehensive, scientific,objective and fair.
Article 14 Drug industry associations shallstrengthen self-discipline, establish and improve industrial standard, promote thesystem construction of industrial integrity, guide and urge enterprises to manufactureand distribute drugs according to applicable laws.
Article 15 Units and individuals that have madesignificant contributions to drug development, manufacturing, distri bution, useand supervision and administration shall be commended and rewarded by the people’sgovernment and its relevant departments at or above the county level in accordingwith relevant provisions.

Chapter 2 Drug Researchand Development and Registration

Article 16 The State supports innovation ofnew drugs which are guided by clinical value and have clear or special therapeuticeffect on human diseases, encourages research and manufacture of drugs which havenew therapeutic mechanisms, treat serious life-threatening diseases or rare diseases,and have multiple targeted systemic regulatory interventions for humans, and promotestechnological advancement for drugs.
The State encourages to utilize modern scienceand technology and traditional methods for traditional Chi nese medicine technologyresearch and development, establishes and improves a technical evaluation systemthat is applicable to traditional Chinese medicine characteristics, and promotesChinese medicine heritage and innovation.
The State takes effective measures, encouragesresearch and development and innovation of pediatric drugs, boosts development ofnew drugs, dosage forms and strengths of pediatric drugs which are in line withpediatric physiological features, and prioritizes review and approval of pediatricdrugs.
Article 17 Drug research and development activitiesshall comply with Good Laboratory Practice(GLP), and Good Clinical Practice(GCP),and ensure that the whole drug research and development process continuously comply with statutory requirements.
GLP and GCP shall be formulated by the drugadministrative department of the State Council jointly with the relevant State Councildepartments.
Article 18 Non-clinical studies for drugs shallcomply with the relevant provisions of the State, with personnel, field, equipment,instruments and management systems corresponding to the study, and ensure the authenticityof the data, documents and samples.
Article 19 For drug clinical trials application,according to the provisions of the drug administrativ e department of the StateCouncil, the applicant shall submit the relevant data, documents and samples suchas research and development methods, specification, pharmacological and toxicologicalstudy results etc truthfully, and be subject to approval by the drug administrativedepartment of the State Council. The drug administrative department of the StateCouncil shall, within 60 working days from the date of acceptance of a clinicaltrial application, decide on approval or not of the application and notify the clinicaltrial applicant; where the applicant is not notified within the stipulated period,the application shall be deemed approved. Bioequivalence study applications shallbe filed for record to the drug administrative department of the State Council.
Drug clinical trials shall be conducted at aclinical trial institution which meets the corresponding criteria. Drug clinicaltrial institutions shall be subject to record administration; detailed measuresshall be formulated by the drug administrative department of the State Council jointlywith the competent health administrative department of the State Council.
Article 20 Conducting drug clinical trials shallcomply with ethical principles, formulate a clinical trial protocol, and be subjectto review and approval by ethics committee.
The ethics committee shall establish an ethicsreview system, to ensure that the ethics review process is independent, objectiveand equitable, supervise standardized conduct of drug clinical trials, protect thelegitima te rights and interests of trial subjects, and safeguard public interest.
Article 21 Conducting a drug clinical trialshall make truthful statement and explanation to the trial subjects or their guardiansin regard to the details such as the clinical trial objective and risks, obtainan informed consent letter signedvoluntarily by the trial subject or his/her guardian,and take effective measures to protect the lawful rights and interests of the trialsubjects.
Article 22 Where safety issues or other risksare discovered during the drug clinical trial period, the clinical trial applicantshall promptly adjust the clinical trial protocol, suspend or terminate the clinicaltrial, and report to the drug administra tive department of the State Council. Wherenecessary, the drug administrative department of the State Council may order theapplicant to adjust the clinical trial protocol, suspend or terminate the clinicaltrial.
Article 23 For drugs under clinical trial whichare used for treatment of serious life-threatening diseases for which there is noeffective treatment, where it is concluded from medical observation that such drugsare beneficial and comply with ethical principles, such drug may be used withinthe clinical trial institution on other patients with the same condition upon reviewby ethics committee and obtaining informed consent.
Article 24 Drugs marketed in China shall besubject to approval by the drug administrative department of the State Council,and obtain a drug approval license, except for traditional Chinese medicinal herbsand traditional Chinese medicine preparations which are not subject to review andapproval administration. The list of traditional Chinese medicinal herbs and traditionalChinese medicine preparations shall be formulated by the drug administrative departmentof the State Council jointly with the competent traditional Chinese medicine administrativedepartment of the State Council.
Applicants for drug registration shall providetrue, adequate and credible data, documents and samples to prove the drug safety,efficacy and quality.
Article 25 The drug administrative departmentof the State Council shall organize CMC, clinical and other technical staff to reviewdrug registration application on drug safety, efficacy and quality as well as qualitymanagement, risk control and liability compensation etc; where the application meetsthe criteria, a drug approval license shall be issued.
During the review and approval, the drug administrativedepartment of the State Council shall combine the review and approval of the chemicaldrug substance, review of the excipients and primary packag ing materials with drugproduct approve the specification, manufacturing process, labeling and leaflet.
Excipients referred to in this Law shall meanthe excipients and additives used in drug manufacturing and formulation.
Article 26 For drug used for treatment of seriouslife-threatening diseases for which there is no effective treatment, as well asdrugs urgently need for public health, where the drug clinical trial data to showefficacy and predictable clinical value. it can be conditionally approved, and therelevant information should be stated in the dug registration license.
Article 27 The drug administrative departmentof the State Council shall optimize the drug review and approval work system, strengthencapability building, establish and improve upon communication, expert advisory mechanismetc, optimize the review and review and approval process, and improve the reviewand approva l productivity.
The review conclusion and rational for drugmarketing approval shall be disclosed for public supervision pursuant to the law.Commercial secrets accessed in the review and approval shall be kept confidential.
Article 28 Drugs on market shall comply withthe national drug specifications. Where the drug specifications approved by thedrug administrative department strict than the national drug specification, theapproved specification shall be implemented; where the national drug specificationis not in place, the approved drug specification shall be complied with.
The "Pharmacopoeia of the People's Republicof China" and drug specifications published by the drug administrative departmentare the national drug specifications.
The drug administrative department of the StateCouncil shall, jointly with the competent health administrative department of theState Council, organize the pharmacopoeia committee to take charge of formulationand revision of the national drug specification.
The drug testing institution set up or appointedby the drug administrative department of the State Council shall be responsiblefor calibration of national drug standard substances and references materials.
Article 29 Drug names listed in the nationaldrug specifications shall be generic drug names. Names listed as generic drug namesshall not be used as a trademark.

Chapter 3 Drug MarketingAuthorization Holder

Article 30 Drug Marketing Authorization Holder(MAH) refers to enterprises or R&D institutions which hold a drug approval license.
MAHs shall, pursuant to the provisions of thisLaw, be liable for non-clinical study, clinical trial, manufacturing and distribution,post-marketinging study, monitoring, reporting and handling of adverse reactionsof the drug product. Other organizations and individuals engaged in drug researchand development, manufacturing, distribution, storage, transportation, use activitiesetc shall abide by the corresponding liability pursuant to the law.
The legal representative and the principal responsibleperson of the MAH shall take full responsibilities for the quality of the drug products.
Article 31 The MAHs shall establish a drug qualityassurance system, and appoint specialized personnel to take charge independentlyof drug quality management.
The MAHs shall conduct the audit on the qualitymanagement system of their entrusted drug manufacturing enterprise and drug distributionenterprise on a regular basis, and supervise the entrusted enterprises to ensuretheir continuous capability on the quality assurance and quality control.
Article 32 The MAHs can either produce drugproducts by themselves or entrust a drug manufacturing enterprise for production.
The MAHs that produce a drug product by themselvesshall obtain a Drug Manufacturing Certificate in accordance with the provisionsof this Law; where a drug is contracted for production, the MAHs shall entrust aqualified drug manufacturing enterprises. An entrustment agreement and a qualityagreement shall be signed between the MAHs and the drug manufacturing enterprises.The MAHs and the entrusted manufacturing enterprises should perform their obligationsunder the agreement strictly.
The drug administrative department(s) of theState Council shall develop guidelines for drug entrusted production and qualityagreements to provide guidance and supervision for the MAHs and the entrusted manufacturersto perform obligations of the drug quality assurance.
Entrusted manufacturing of blood products, narcoticdrugs, psychotropic drugs, and medicinal toxic drugs, drug precursor chemicals isprohibited, unless otherwise stipulated by the drug administrative department(s)of the State Council.
Article 33 The MAHs shall establish a marketingrelease procedure, to conduct the inspection of drug products released by manufacturingenterprises, and the drug products can be released only after signed off by theauthorized qualified person. . Drug products which do not conform to the nationaldrug standards shall not be released.
Article 34 The MAHs can either distribute drugproducts by themselves or entrust a drug distributor for distribution. The MAHsengaged in drug retail activities shall obtain a drug supply certificate.
The MAHs engaged in distribution of drugs bythemselves shall meet the criteria stipulated in Article 52 of this Law; for entrusteddistribution, the entrusted drug distribution enterprise shall meet the criteria.An entrustment agreement shall be signed between the MAHs and the entrusted drugdistributor. The MAHs and the entrusted distributor shall perform their obligationsunder the agreement strictly.
Article 35 If the MAH, the drugmanufacturing enterprise or the drug distributor entrusts a third party tostorage and transport the drug products, an assessment should be conducted on theentrusted party’s capacities of the quality assurance and risk management. An entrustmentagreement should be signed with the entrusted party to specify the drug qualityresponsibility, operation procedures and other aspects. The entrusted party shallbe supervised by the MAHs, the drug manufacturing enterprises or the drug distributors.
Article 36 The MAHs, the drug manufacturingenterprises, the drug distributors, and the medical institutions shall establishand implement drug quality traceability systems, to guarantee the traceability ofdrug products.
Article 37 The MAHs shall establish an annualreport system, to report annually to the drug administrative department(s) underthe provinces, autonomous regions, or municipality directly under the Central Government,about the drug production and the distribution, the post-marketinging studies, andthe risk management, etc., in accordance with the regulations.
Article 38 Where the MAH is an overseas enterprise,the enterprise legal person within the territory of the People’s Republic of Chinashall be designated to fulfill the obligations of the MAH and assume the joint liabilityof the MAH together.
Article 39 The manufacturers of traditionalChinese medicine preparation shall fulfill relevant obligations of the MAH, andshall implement whole process management for the manufacturing and distributionof the preparation, establish a quality traceability system of the preparation toensure the safety, efficacy and traceability of the preparation.
Article 40 The MAHs can transfer the drug approvallicense after approval by the drug administrative department(s) of the State Council.The acquiring party should have the ability of the quality management, risk preventionand control and liability of compensation to ensure the safety and efficacy ofthe drug, and fully fulfill the obligations of the MAH according to the law.

Chapter 4 Drug Manufacturing

Article 41 Undertaking of drug manufacturingshall be subject to approval by the drug administrative department of the People'sGovernment of the province, autonomous region or municipality directly under theCentral Government at their locality, and shall obtain the Drug Manufacturing Certificate.It is not permitted to manufacture drugs without the Drug ManufacturingCertificate.
The Drug Manufacturing Certificate shall statethe expiry date and the scope of manufacturing, and be subject to review and promulgateupon expiry date.
Article 42 Undertaking of drug manufacturingshall satisfy the following criteria:
employing pharmacy technicians, engineers andthe corresponding technicians who obtain qualifications pursuant to the law;
having factory premises, facilities and hygieneenvironment that are applicable to drug manufacturing;
having the setup, staff and the requisite equipmentfor quality management and quality inspection for the drugs manufactured by themanufacturer;
having rules and regulations to ensure the qualityof drugs, and comply with the requirements of Good Manufacturing Practice whichis stipulated by the drug administrative department of the State Council pursuantto this Law.
Article 43 Undertaking of drug manufacturingshall comply with Good Manufacturing Practice, establish and improve upon a drugmanufacturing quality management system, ensure the whole drug manufacturing processcontinuously comply with statutory requirements.
The legal representative and the key person-in-chargeof a drug manufacturing enterprise shall be fully responsible for the enterprise'sdrug manufacturing activities.
Article 44 The drug shall be manufactured inaccordance with the national drug standards and the manufacturing process approvedby the drug administrative department. The manufacturing and inspection recordsshall be complete and accurate and shall not be fabricated.
The prepared slices of Chinese crude drugs shallbe processed in accordance with national drug standards; where the national drugstandards do not stipulate, the processing shall comply with the processing normsformulated by the drug administrative department of the People's Government of theprovince, autonomous region or municipality directly under the Central Government.The processing regulations formulated by the drug administrative department of thePeople's Government of the province, autonomous region or municipality directlyunder the Central Government shall be filed to the drug administrative departmentof the State Council. Where the processing does not comply with the national drugstandards or the processing regulations formulated by the drug administrative departmentof the People's Government of the province, autonomous region or municipality directlyunder the Central Government, the prepared slices of Chinese crude drugs shall notbe released from factory and marketed.
Article 45 The drug substances and excipientsrequired in drug manufacturing shall comply with medicinal requirements and therelevant requirements of the Good Manufacturing Practice.
For drug manufacturing, shall audit the suppliersof drug substances and excipients etc pursuant to the provisions, to ensure thatthe purchased and used drug substances and excipients comply with the requirementsstipulated in the preceding paragraph.
Article 46 Packaging materials andcontainers which come into direct contact with drugs shall comply with medicinalrequirements and comply with the standards for ensuring human health and safety.
Where the packaging materials and containerswhich come into direct contact with drugs are not compliant, the drug administrativedepartment shall order the manufacturer to stop using such packaging materials andcontainers.
Article 47 Drug manufacturing enterprises shallconduct drug quality inspection. The drug product which do not comply with the nationaldrug standards shall not be released from factory.
Drug manufacturing enterprises shall establishdrug product release procedures, and specify the release standards and criteria.Where the standards and criteria are complied with, can be released only upon signatureby the Qualified Person.
Article 48 Drug packaging shall comply withdrug quality requirements, and be convenient for stor age, transportation and medicaluse.
Shipments of the Chinese herbal medicine shallbe packed. Each packaging shall state the product name, place of origin, date, supplier,and be affixed with a quality conformance mark.
Article 49 Drug packaging shall be printed oraffixed with a label and include the package insert pursuant to the provisions.
The label or package insert shall state thegeneric name, ingredient, strength, name and address of MAH, name and address ofthe manufacturing enterprise, approval number, product batch number, date of manufacturing,period of validity, indications or functions, usage, dosage, contraindication, adversereactions and precautions. The wording of the label and package insert shall beclear, and the date of manufacturing and period of validity shall be prominent anddiscernible.
The label and package insert for narcotics,psychological drugs, toxic drugs for medical use, radiative drugs, drugs for externaluse and OTC drugs shall be printed with the stipulated mark.
Article 50 Staff of MAHs, drug manufacturingenterprises, drug distributors and medical institutions who come into direct contactwith drugs shall undergo health examination annually. Persons who suffer froman infectious disease or other diseases which may cause contamination to drugs shallnot engage in work which involve direct contact with drugs.

Chapter 5 Drug Distribution

Article 51 Undertaking of drug wholesale shallbe subject to approval by the drug administrative department of the people's governmentof the province, autonomous region or municipality directly under the Central Governmentat their locality, and shall obtain a drug supply certificate Undertaking of drugretail shall be subject to approval by the drug administrative department of a people'sgovernment of county level or above at the locality, and shall obtain a drug supplycertificate. Operation of drug distribution without a drug supply certificate isprohibited.
A drug supply certificate shall state the validityperiod and the scope of business, and be subject to review and reissuance upon expiryof the validity period.
The drug administrative department implementingcertification of drug distribution shall, in addition to complying with the criteriastipulated in Article 52 of this Law, adhere to the principle of convenience ofdrug purchase for the public.
Article 52 Undertaking of drug distributionactivities shall meet the following criteria:
having legally qualified pharmacists or otherdrug technicians;
having business premises, equipment, warehousingfacilities and hygiene environment corresponding to the drug distribution;
having the quality management units or personnelcorresponding to the drug distribution; and
having rules and system to ensure drug quality,and comply with the requirements of Good Supply Practice formulated by the drugadministrative department of the State Council pursuant to this Law.
Article 53 Undertaking drug distribution activitiesshall comply with the Good Supply Practice, establish and improve the quality managementsystem for drug distribution, and ensure that the whole drug distribution processcontinuously comply with statutory requirements.
The State encourages and guides drug retailchain operation. The headquarters of a drug retai l chain business enterprise shallestablish a unified quality management system, perform management responsibilitiesfor the business activities of the retail chain enterprises.
The legal representative and the key person-in-chargeof a drug distribution enterprise shall be fully responsible for the enterprise'sdrug distribution activities.
Article 54 The State implements a classificationadministration system for preion drugs and over-the-counter drugs. Detailedmeasures shall be formulated by the drug administrative department of the StateCouncil jointly with the health administrative department of the State Council.
Article 55 MAHs, drug manufacturing enterprises,drug distribution enterprises and medical institutions shall procuredrugs froman MAH or an enterprise qualified to engage in drug manufacturing or distribution,except for procurement of traditional Chinese medicine herbs which are not subjectto approval administration.
Article 56 Drug distribution enterprises procuringdrugs for sales shall establish and implement a purchase inspection and acceptancesystem, and check the certificate of drug quality and other marks; where the stipulatedrequirements are not met, such drugs shall not be procured and sold.
Article 57 Drug distribution enterprise shallkeep authentic and complete procurement and sales records when procuring and sellingdrugs. The procurement and sales records shall state the drug generic name, dosageform, strength, batch number, shelf-life, MAH, manufacturing enterprise, procurementor sales unit, procurement or sales quantity, procurement or sales price, procurementor sales date and other contents stipulated by the drug administrative departmentof the State Council.
Article 58 Drug distribution enterprises engagingin drug retail shall state the administration, dosage and precautions accuratelyand correctly; preion for dispensing shall be verified; drugs listed in apreion shall not be arbitrar ily changed or substituted. It shall be refusedto dispense incompatible or over-dose preions; where necessary, the preionmay be dispensed only upon correction or resigning by the prescribing physician.
Drug distribution enterprises engaging in saleof traditional Chinese medicine herbs shall state the place of origin.
Pharmacists or other pharmacy technicians whohave obtained qualifications pursuant to the law shall be responsible for the enterprise'sdrug management, preion examination and dispensing, and guidance of rationaluse of drugs, etc.
Article 59 Drug distribution enterprises shallformulate and implement drug storage system, adopt the requisite refrigeration,anti-freezing, dehumidifying, insect and rodent control measures, etc. to ensuredrug quality.
Drug stock-in and stock-out shall be subjectto an examination system.
Article 60 Traditional Chinese medicine herbsmay be sold at urban and rural trade markets, unless otherwise stipulated by theState Council.
Article 61 MAHs and drug distribution enterprisesengaging in online drug sales shall comply with the relevant provisions of thisLaw on drug distribution. Detailed administrative measures shall be formulated bythe drug administrative department of the State Council jointly with the healthadministrative department of the State Council.
Drugs subject to special administration stipulatedby the State, such as vaccines, blood products, narcotic drugs, psychiatric drugs,toxic drugs for medical use, radioactive drugs, drug precursor chemicals, etc. shallnot be sold online.
Article 62 Third party platform providersfor online drug sales shall file record with the drug administrative departmentof the people's government of the province, autonomous region or municipalitydirectly under the Central Government at their locality pursuant to the provisionsof the drug administrative department of the State Council.
Third party platform providers shall examinethe qualifications of MAHs and drug distribution enterprises applying to operateon their platform, ensure that they comply with statutory requirements, and managedrug distribution activities carried out on their platform.
Where a third party platform provider discoversthat an MAH or a drug distribution enterprise operating on its platform hascommitted a violation of this Law, it shall promptly stop the offence and forthwithreport to the drug administrative department of the county people's government atits locality; where the offence is a serious violation, the third party platformprovider shall forthwith cease to provide the online transaction platform service.
Article 63 Newly-discovered and overseas-introducedherbs may be sold only upon approval by the drug administrative department of theState Council.
Article 64 Drugs shall be imported from approveddrug-importing ports, and the drug-importing enterprise shall file record with thedrug administrative department at the locality of the port. The customs shall processcustoms clearance formalities with the import drug customs clearance form issuedby the drug administrative department. Where there is no import drug customs clearanceform, the customs shall not release the cargo.
The drug administrative department at the localityof the port shall notify the drug control institute to conduct spot inspection onthe imported drugs pursuant to the provisions of the drug administrative departmentof the State Council.
The approved drug-importing ports shall be proposedby the drug administrative department of the State Council jointly with the GeneralAdministration of Customs, and subject to approval by the State Council.
Article 65 Where a medical institution has urgentclinical needs for small quantities of imported drugs, such drugs may be importedupon approval by the drug administrative department of the State Council or thepeople's government of the province, autonomous region or municipality directlyunder the Central Government authorized by the State Council. Imported drugs shallbe used for specific medical purposes within designated medical institutions.
Small quantities of drugs brought into Chinaby individuals for personal use shall be handled pursuant to the relevant provisionsof the State.
Article 66 Importers and exporters of narcoticdrugs and psychiatric drugs within the scope stipulated by the State shall presentthe importation permit or exportation permit issued by the drug administrative departmentof the State Council.
Article 67 Importation of drugs with unclearefficacy, significant adverse reactions or otherwise harmful to human health isprohibited.
Article 68 The drug administrative departmentof the State Council shall appoint a drug control institute to inspect the followingdrugs prior to sales or importation; drugs which have not been inspected or do notpass inspection shall not be sold or imported:
drugs sold in China for the first time;
biological products stipulated by the drug administrativedepartment of the State Council; and
any other drugs stipulated by the State Council.

Chapter 6 PharmacyAdministration of Medical Institutions

Article 69 Medical institutions shall employpharmacists or other drug professionals who obtain qualifications pursuant to thelaw to take charge of the medical institution's drug management, checking and dispensingof preions, medication guidance etc. No one who is not a drug professionalshall engage directly in pharmacy technical work.
Article 70 Medical institutions procuring drugsshall establish and implement a purchase inspection and acceptance system, to inspectthe qualification certificates and other marks of the drugs; where the stipulatedrequirements are not satisfied, such drugs shall not be procured and used.
Article 71 Medical institutions shall have premises,equipment, warehousing facilities and hygiene environment corresponding to use ofdrugs, formulate and implement a drug storage system, and adopt the requisite refrigeration,anti-freezing, dehumidifying, insect and rodent control measures etc, to ensurethe quality of drug.
Article 72 Medical institutions shall adhereto the principle of safe, effective, economical and reasonable medication, complywith the drug clinical application guidelines, clinical diagnosis and treatmentguide and drug package insert etc for rational use of drugs, and review the suitabilityof physician preion and medication orders.
Non-medical institutions using drugs shall complywith the relevant provisions on use of drugs by medical institutions in this Law.
Article 73 When dispensing preions, pharmacistsor other drug professionals who obtained qualifications pursuant to the law shallcheck the preion, and shall not arbitrarily change or substitute the drugslisted in the preion. For preions with drug incompatibilities or overdose,the pharmacist shall refuse to dispense; when necessary, the pharmacist may dispensethe preion only after the prescribing physician corrects the preionor signs again.
Article 74 Medical institutions engaging inpreparing drug preparations shall be subject to approval by the drug administrativedepartment of the People's Government of the province, autonomous region or municipalitydirectly under the Central Government at their locality, and obtain a medical institutionpreparation permit. Preparation of drug preparation without a medical institutionpreparation permit is prohibited.
A medical institution preparation permit shallstate the validity period, and be subject to review and reissuance upon expiry ofthe validity period.
Article 75 Medical institutions engaging inpreparing drug preparations shall have facilities, management system, inspectionequipment and hygiene environment which can ensure formulation quality.
Preparation of drug preparations by medicalinstitutions shall be carried out in accordance with the approved process, the requiredactive drug ingredients, excipients and packaging materials etc shall comply withmedicinal requirements.
Article 76 The drug preparation prepared bya medical institution shall be ones that are to meet the clinical need of theinstitutionbut not available in the market, and shall be subject to approval by the drug administrativedepartment of the People's Government of the province, autonomous region or municipalitydirectly under the Central Government at the locality, unless otherwise specifiedby the laws for the preparation of traditional Chinese medicine preparations.
The drug preparations prepared by a medicalinstitution shall be subject to quality inspection pursuant to the provisions; uponpassing inspection, the formulations shall be used in the medical institution itsown in accordance with physician preions. Upon approval by the drug administrativedepartment of the State Council or the drug administrative department of the People'sGovernment of the province, autonomous region or municipality directly under theCentral Government, the drug preparation prepared by the medical institution maybe allocated and used by other designated medical institutions.
Drug preparation prepared by medical institutionsshall not be sold on the market.

Chapter 7 Drug Post-marketingManagement

Article 77 MAH shall formulate drug post-marketingrisk management plan, take the initiative to carry out drug post- marketing study,to further confirm the safety, efficacy and quality controllability of the drugs,and strengthen continuous management of drugs launched to market.
Article 78 For drugs given conditional approval,the MAH shall adopt the corresponding risk management plan, and complete the relevantstudy within the stipulated period in accordance with the requirements; where theMAH is unable to complete the study within the stipulated period in accordance withthe requirements or is unable to prove that the benefits outweigh the risks, thedrug administrative department of the State Council shall handle the matter pursuantto the law, and may revoke the Drug approval license.
Article 79 Changes in the drug manufacturingprocess shall be subject to administration by classifications in accordance withthe risks and impact of the change on drug safety, efficacy and quality controllability.Major changes shall be subject to approval by the drug administrative departmentof the State Council, other changes shall be subject to filing or reporting to thedrug administrative department of the State Council.
MAH shall, pursuant to the provisions of thedrug administrative department of the State Council, conduct comprehensive evaluationand validation of the changes impact on drug safety, efficacy and quality controllability.
Article 80 MAH shall conduct adverse reactionsmonitoring of marketed drug, take the initiative to coll ect, track and analyzeinformation on suspected adverse reactions to the drugs, and promptly adopt riskcontrol measures for drugs for which risks are identified.
Article 81 MAH, drug manufacturing enterprises,drug distributors and medical institutions sh all regularly inspect the quality,efficacy and adverse reactions of drugs manufactured, distributed and used by them.Cases of suspected adverse reactions shall be promptly reported to the drug administrativedepartments and the competent health administrative authority. Detailed measuresshall be formulated by the drug administrative department of the State Council jointlywith the competent health administrative department of the State Council.
For drugs for which serious adverse reactionsare confirmed, the drug administrative department of the State Council or the drugadministrative department of the People's Government of the province, autonomousregion or centrally - administered municipality shall adopt emergency control measuresin accordance with the actual conditions to stop manufacturing, sale and use etc,and shall organize evaluation within five days, and issue an administrative handlingdecision within 15 days from the date of the evaluation conclusion pursuant to thelaw.
Article 82 Where drugs have quality issues orother potential safety concerns, MAH shall immediately stop selling, notify therelevant drug distributors and medical institutions to stop sales and use, recallsold drugs, promptly announce recall information, forthwith stop manufacturing wherenecessary, and report drug recall and handling situation to the drug administrativedepartment and the health administrative department of the People's Government ofthe province, autonomous region or centrally-administered municipality. The drugmanufacturing enterprise, drug distributors and medical institutions shall cooperate.
Where the MAH does not recall the drugs accordingto law, the drug administrative department of the People's Government of the province,autonomous region or centrally-administered municipality shall order the MAH torecall the drugs.
Article 83 MAH shall conduct regular post-marketingevaluation of the safety, efficacy and quality controllability of the drugs launchedto market. Where necessary, the drug administrative department of the State Councilmay order the MAH to conduct post-marketing evaluation or directly organize post-marketingevaluation.
Upon evaluation, the Drug approval license ofdrugs with unclear efficacy, significant adverse reactions or otherwise harmfulto human health shall be revoked.
Where the drug approval license is revoked,the drugs shall not be manufactured or imported, sold and used.
Drugs which the Drug approval license is revokedor drug is expired, etc. shall be destroyed or decontaminated pursuant to the lawunder the supervision of the drug administrative departments.

Chapter 8 Drug Pricingand Advertising

Article 84 The State improves upon the drugprocurement administration system, monitors drug pricing, conducts costs and pricinginvestigation, strengthens supervision and inspection of drug pricing, investigatesand deals with illegal drug pricing acts such as price monopolies, bull campaignsetc, and safeguards drug pricing order.
Article 85 For drugs subject to market-adjustedpricing pursuant to the law, MAH, drug manufacturing enterprises, drug distributionenterprises and medical institutions shall formulate pricing in accordance withthe principles of "fairness, reasonableness, honesty and integrity, quality-pricematch", and provide reasonably-priced drugs to drug users.
MAHs, drug manufacturing enterprises, drug distributionenterprises and medical institutions shall comply with the provisions of the competentdrug pricing administrative department of the State Council on administration ofdrug pricing, formulate and state drug retail prices, and shall not commit profiteering,price monopoly and price fraud etc.
Article 86 Drug MAHs, drug manufacturing enterprises,drug distribution enterprises and medical institutions shall provide informationon actual procurement and sale prices and procurement and sale quantities of thedrugs pursuant to the law to the competent drug pricing administrative department.
Article 87 Medical institutions shall providepatients with the price list of drugs used by them, announce the prices of commonly-useddrugs truthfully pursuant to the provisions, and strengthen management of reasonabledrug use. Detailed measures shall be formulated by the competent health administrativedepartment of the State Council.
Article 88 Drug MAHs, drug manufacturing enterprises,drug distribution enterprises and medical institutions shall not give or receiverebates or other improper gains in procurement and sale of drugs.
Drug MAHs, drug manufacturing enterprises, drugdistribution enterprises or their agents shall not give monies or other impropergains under any pretext to the person(s)-in-charge, drug procurement staff, physicians,pharmacists etc of medical institutions using their drugs. The person(s)-in-charge,drug procurement staff, physicians, pharmacists etc of medical institutions shallnot receive monies or other improper gains under any pretext from drug MAHs, drugmanufacturing enterprises, drug distribution enterprises or their agents.
Article 89 Drug advertisements shall be subjectto approval by the advertisement examination authorities determined by the People'sGovernment of the province, autonomous region or municipality directly under theCentral Government at the locality of the advertiser; drug advertisements shallnot be published without approval.
Article 90 The contents of drug advertisementsshall be true and legitimate, shall be based on the literature of the drug approvedby the drug administrative department of the State Council, and shall not containfalse information.
Drug advertisements shall not assert or guaranteeefficacy or safety of the advertised drug; shall not make use of the name or image of State agencies, research institutes, academicinstitutions, industry associations or experts, academicians, physicians, pharmacists,patients etc for recommendation or endorsement.
Non-drug advertisement shall not involve advertisingof drugs.
Article 91 For drug pricing and advertisingmatters not stipulated in this Law, the provisions of the Pricing Law of the People'sRepublic of China, the Anti-monopoly Law of the People's Republic of China, theLaw of the People's Republic of China Against Unfair Competition, the AdvertisingLaw of the People's Republic of China etc shall apply.

Chapter 9 Drug Reserveand Supply

Article 92 The State implements a drug reservesystem by the establishment of Central and local drug reserves.
In the event of serious disasters, epidemicoutbreaks or other emergencies, urgent drug deployment may be carried out pursuantto the provisions of the Emergency Response Law of the People's Republic of China.
Article 93 The State implements essential drugssystem, to select essential drugs of appropriate quantities, strengthen the organizingof manufacture and reserve, improve the supply capacity for essential drugs, andsatisfy basic medication needs for disease prevention and treatment.
Article 94 The State establishes a drug supplymonitoring system, to promptly gather, compile and analys is the supply informationof shortage drug, implement advance warning for shortage drug, and adopt countermeasures.
Article 95 The State implements a list administrationof shortage drug. Detailed measures shall be formulated by the competent healthadministrative department of the State Council jointly with the drugadministrative department of the State Council etc.
Where a MAH stops to manufacture the shortagedrug, it shall be reported to the drug administrative department of the State Councilor the drug administrative department of the People's Government of the province,autonomous region or municipality directly under the Central Government.
Article 96 The State encourages the research,development and manufacture of shortage drug, and implements priority review andapproval for the shortage drug for urgent clinical needs, or the new drugs for preventionand treatment of serious infectious diseases and rare diseases etc.
Article 97 The State Council may restrict orprohibit exportation of shortage drug. Where necessary, the relevant State Councildepartments may adopt measures such as organizing the manufacture, implementingprice intervention, or expanding importation etc to secure drug supply.
The drug marketing authorization holder, drugmanufacturing enterprises and drug distribution enterprises shall ensure drug manufactureand supply pursuant to the provisions.

Chapter 10 Supervisionand Administration

Article 98 Manufacturing (including preparation,same hereinafter), sale or use of fake drugs and inferior drugs are prohibited.
Any of the following circumstances shall bedeemed as fake drugs:
the ingredients in the drugs are not compliantwith the ingredients stipulated in the national drug standards;
a non-drug substance is simulated as a drugor one drug is simulated as another;
deteriorated drugs; or
the indications stated for the drugs exceedthe stipulated scope.
Any of the following circumstances shall bedeemed as inferior drugs:
the contents of the drugs are not compliantwith the contents stipulated in the national drug standards;
contaminated drugs;
drugs for which the validity period is not statedor the validity period is altered;
drugs for which the product batch number isnot stated or the product batch number is altered;
the validity period of the drugs has expired;
drugs with unauthorized addition of preservativesor excipients; or
any other drugs which do not comply with thedrug standards.
Manufacturing or importation of drugs withouta drug approval certificate is prohibited; use of active drug ingredients, packagingmaterials and containers which have not been reviewed and approved pursuant to theprovisions for drug manufacturing is prohibited.
Article 99 The drug administrative departmentsshall, pursuant to the provisions of laws and regulations, supervise and inspectdrug research and development, manufacturing, distribution and drug use by organizationsetc, and where necessary, conduct extended inspection on organizations and individualsproviding products or services for drug research and development, manufacturing,distribution and use; the relevant organizations and individuals shall cooperate,and shall not refuse or conceal information.
The drug administrative departments shall implementfocused supervision and inspection for high-risk drugs.
Where there is evidence to prove that thereare safety hazards, the drug administrative departments shall, based on supervisionand inspection findings, adopt measures such as issue a warning, schedule an interview,order the entity to make correction within a stipulated period, suspend manufacturingand sale, use, importation etc, and shall promptly announce inspection and handlingoutcome.
When conducting supervision and inspection,the drug administrative departments shall present their credentials, andkeep confidentialityof commercial secrets which have come into their knowledge during supervision andinspection.
Article 100 The drug administrative departmentsmay, based on supervision and administration needs, inspect the drug quality ofrandom samples. Random samples shall be taken pursuant to the provisions for inspection,and no fees shall be collected for inspection; random samples are required to bepurchased. The requisite expenses shall be reimbursed pursuant to the provisionsof the State Council.
Where there is evidence to prove that the drugsand the relevant materials thereof may harm human health, the drug administrativedepartments may seize or confiscate the drugs, and shall issue an administrativehandling decision within seven days; where there is a need to inspect the drugs,an administrative handling decision shall be issued within 15 days from issuanceof the inspection report.
Article 101 The State Council and the drug administrativedepartments of People's Governments of provinces, autonomous regions and municipalitydirectly under the Central Government shall announce the drug quality findings ofrandom samples inspected on a regular basis; where the announcement is improper,correction shall be made within the scope of the original announcement.
Article 102 A party concerned who disagreeswith the drug inspection findings may apply to the original drug inspection agencyor the drug inspection agency established or appointed by the higher- level drugadministrative departments for review within seven days from receipt of the druginspection findings, and may apply directly to the drug inspection agency establishedor appointed by the drug administrative department of the State Council for review.The drug inspection agency which accepts the application for review shall issuea review conclusion within the timeframe stipulated by the drug administrative departmentof the State Council.
Article 103 The drug administrative departmentsshall inspect compliance with GMP, GSP, GLP, GCP by MAHs, drug manufacturing enterprises,drug distribution enterprises, drug non-clinical safety evaluation research institutes,drug clinical trial organizations etc, and supervise these entities to continuouslycomply with statutory requirements.
Article 104 The State establishes a professionaland specialized team of drug inspectors. The inspectors shall be familiar with druglaws and regulations, and have professional knowledge in drugs.
Article 105 The drug administrative departmentsestablishes a drug safety credit record for MAHs, drug manufacturing enterprises,drug distribution enterprises, drug non-clinical safety evaluation research institutes,drug clinical trial organizations and medical institutions, to record issuance ofpermits, regular supervision and inspection findings, investigation and handlingof illegal acts etc, announce to the public pursuant to the law and promptly updaterecords; increase supervision and inspection frequency for entities with poor creditrecords, and may implement joint punishment pursuant to the provisions of the State.
Article 106 The drug administrative departmentsshall announce their email address and hotline number to accept enquiries, complaints,reports, and shall promptly reply, verify and handle enquiries, complaints, reportspursuant to the law. For verified reports, the informants shall be rewarded pursuantto the relevant provisions.
The drug administrative departments shall keepthe identity information of informants confidential and protect the legitimate rightsand interests of informants. Where an informant lodges a report against his/heremployer, the employer shall not retaliate against the informant by way of rescission,amendment of his/her labour contract or otherwise.
Article 107 The State implements a unified announcementsystem for drug safety information. General information on national drug safety,drug safety risk warning information, and serious drug safety incidents, as wellas information on investigation and handling thereof and other information requiredby the State Council to be announced on a unified basis, shall be announced by thedrug administrative department of the State Council on a unified basis. Drug safetyrisk warning information, serious drug safety incidents and information on investigationand handling thereof which have an impact on specific region may be announced bythe drug administrative department of the People's Government of the relevant province,autonomous region or -municipality directly under the Central Government. Unauthorizedannouncement of the aforesaid information is prohibited.
Announcement of drug safety information shallbe timely, accurate, comprehensive, and accompanied by necessary explanation toavoid misleading.
No organization or individual shall fabricateor disseminate false drug safety information.
Article 108 People's Governments of county leveland above shall formulate emergency plan for drug safety incidents. MAHs, Drug manufacturingenterprises, Drug distribution enterprises and medical institutions etc shall formulatetheir action plan for handling drug safety incidents, and organize and conduct trainingand drills.
Upon occurrence of a drug safety incident, aPeople's Government of county level and above shall forthwith organize countermeasuresin accordance with the emergency plan; the relevant organization shall forthwithadopt effective measures to handle the matter and prevent escalation.
Article 109 Where a drug administrative departmentfails to discover systemic risks of drug safety promptly or fails to eliminate drugsafety hazards within their supervision and administration region promptly, thePeople's Government or the drug administrative department of the higher-level People'sGovernment shall schedule an interview with the person- in-charge of the drug administrativedepartment.
Where a local People's Government fails to performdrug safety duties or fails to eliminate regional serious drug safety hazards promptly,the higher-level People's Government or the drug administrative department of thehigher-level People's Government shall schedule an interview with the person-in-chargeof the local People's Government.
The department and the local People's Governmentshall forthwith adopt measures to rectify drug supervision and administration work.
The scheduled interview and the rectificationshall be included in the drug supervision and administration work review and appraisalrecords of the relevant department and the local People's Government.
Article 110 A local People's Government andits drug administrative departments shall not use means such as requiring implementationof drug inspection, examination and approval etc to restrict or exclude drugs ofnon-local MAHs or drug manufacturing enterprises from entering the locality.
Article 111 The drug administrative departmentsand the professional technical organizations for drugs established or appointedby the drug administrative departments shall not participate in drug manufacturingand business activities, and shall not recommend or supervise drug manufacturingand sale in their capacity.
Staff of the drug administrative departmentsand the professional technical organizations for drugs established or appointedby the drug administrative departments shall not participate in drug manufacturingand business activities.
Article 112 Where the State Council has otherspecial administrative provisions on narcotic drugs, psychiatric drugs, toxic drugsfor medical use, radioactive drugs, pharmaceutical precursor chemicals etc, suchprovisions shall prevail.
Article 113 Upon discovery of a drug violationwhich allegedly constitutes a criminal offence, the drug administrative departmentsshall promptly forward the case to the public security authorities.
Where it is not necessary to pursue criminalliability pursuant to the law or criminal punishment is not required pursuant tothe law, but it is necessary to pursue administrative liability, the public securityauthorities, the People's Procuratora te and the People's Court shall promptly forwardthe case to the drug administrative departments.
Where the public security authorities, the People'sProcuratorate and the People's Court seek assistance from the drug administrativedepartments, the ecological environment administrative authorities etc to provideinspection conclusion and confirmation opinion as well as decontamination of theinvolved drugs etc, the relevant authorities shall promptly provide and assist.

Chapter 11 Legal Liability

Article 114 Where a violation of the provisionsof this Law constitutes a criminal offence, criminal liability shall be pursuedin accordance with the law.
Article 115 Offenders who engage in drug manufacturingand sale without obtaining a drug manufacturing Certificate, drug business permitor medical institution preparation permit shall be ordered to close down, the drugsand illegal income from the illegal manufacturing and sale shall be confiscated,and a fine ranging from 15 times to 30 times of the value of the drugs from theillegal manufacturing and sale (including sold and unsold drugs, same hereinafter)shall be imposed simultaneously; where the value of the drugs is less than RMB100,000,the fine shall be computed in accordance withRMB100,000.
Article 116 For manufacturing and sale of fakedrugs, the drugs and illegal income from the illegal manufacturing and sale shallbe confiscated, and the offender shall be ordered to suspend manufacturing and distributionand make correction, the drug approval certificate shall be revoked, and a fineranging from 15 times to 30 times of the value of the drugs from the illegal manufacturingand sale shall be imposed simultaneously; where the value of the drugs is less thanRMB100,000, the fine shall be computed in accordance with RMB100,000; in seriouscases, the drug manufacturing permit, drug business permit or medical institutionpreparation permit shall be revoked, and the drug administrative authorities shallnot accept an application from the offender within the next 10 years; where thedrug marketing permit holder is an overseas enterprise, its drugs shall be bannedfrom importation for the next 10 years.
Article 117 For manufacturing and sale of inferiordrugs, the drugs and illegal income from the illegal manufacturing and sale shallbe confiscated, and a fine ranging from 10 times to 20 times of the value of thedrugs from the illegal manufacturing and sale shall be imposed simultaneously;where the value of the drugs from the illegal manufacturing and wholesale is lessthan RMB100,000, the fine shall be computed in accordance with RMB100,000; wherethe value of the drugs from the illegal retail is less than RMB10,000, the fineshall be computed in accordance with RMB10,000; in serious cases, the offender shallbe ordered to suspend manufacturing and distribution, and the drug approval certificate,drug manufacturing permit, drug business permit or medical institution preparationpermit may be revoked.
For manufacturing and sale of traditional Chinesemedicine preparations which do not comply with drug standards but there is no impacton safety or effectiveness, the offender shall be ordered to make correction withina stipulated period, and be given a warning; and may be subject to a fine rangingfrom RMB100,000 to RMB500,000.
Article 118 For manufacturing and sale of fakedrugs, or manufacturing and sale of inferior drugs where the case is serious, theincome derived by the legal representative, the principal responsible person, thepersons directly in charge and the other persons responsible from the entity duringthe period of occurrence of the illegal act shall be confiscated, a fine rangingfrom 30% to 300% of the income shall be imposed on these individuals simultaneously,and they shall be banned permanently from engaging in drug manufacturing and businessactivities and may be detained by the public security authorities for five daysto 15 days.
The active drug ingredients, excipients, packagingmaterials and manufacturing equipment used by the manufacturers for manufacturingof fake drugs or inferior drugs shall be confiscated.
Article 119 Organizations using drugs whichuse fake drugs or inferior drugs shall be punished pursuant to the provisions onsale of fake drugs and retail of inferior drugs; in serious cases, where the legalrepresentative, the principa l responsible person, the persons directly in chargeand the other persons responsible hold a medical and health practitioner certificate,the practitioner certificate shall be revoked.
Article 120 Where a person facilitates storageor transportation when he/she is or should be aware that the drugs are fakedrugs or inferior drugs or fall under item (1) to item (5) of the first paragraphof Article 124 of this Law, all storag e and transportation income shall be confiscatedand a fine ranging from one to five times the amount of illegal income shall beimposed simultaneously; in serious cases, a fine ranging from five to 15 times theamount of illegal income shall be imposed simultaneously; where the amount of illegalincome is less than RMB50,000, the fine shall be computation in accordance withRMB50,000.
Article 121 The punishment decision on fakedrugs or inferior drugs shall state the quality inspection conclusion of the druginspection agency pursuant to the law.
Article 122 For forgery, alteration, lease,borrowing, illegal sale and purchase of permit or drug approval certificate, illegalincome shall be confiscated and a fine ranging from one to five times the amountof illegal income shall be imposed simultaneously; in serious cases, a fine rangingfrom five to 10 times the amount of illegal income shall be imposed simultaneously,the drug manufacturing permit, drug business permit, medical institution preparationpermit or drug approval certificate shall be revoked, the legal representative,and the principal responsible person, the persons directly in charge and the otherpersons responsible shall be subject to a fine ranging from RMB20,000 to RMB200,000,banned from engaging in drug manufacturingand business activities for the next 10 years, and may be detained by the publicsecurity authorities for five days to 15 days; where the amount of illegal incomeis less than RMB100,000, the fine shall be computation in accordance with RMB100,000.
Article 123 Where an entity provides false certificate,data, materials, samples or adopts other measures to obtain a clinical trial permit,drug manufacturing permit, drug business permit, medical institution preparationpermit or drug registration certificate fraudulently, the relevant permit shallbe revoked, and it shall be banned from submitting the corresponding applicationfor the next 10 years and shall be subject to a fine ranging from RMB500,000 toRMB5 million simultaneously; in serious cases, the legal representative, the keyperson-in-charge, the directly-accountable person-in- charge and other directly-accountablepersonnel shall be subject to a fine ranging from RMB20,000 to RMB200,000, and bannedfrom engaging in drugmanufacturing and business activities for the next 10 years,and may be detained by the public security authorities for five days to 15 days.
Article 124 For any of the following violationsof this Law, the drugs and illegal income from illegal manufacturing, importationand sale as well as the active drug ingredients, excipients, packaging materialsand manufacturing equipment used specifically for illegal manufacturing shall be confiscated, andthe offender shall be ordered to suspendmanufacturing and distribution and make correction, and simultaneously be subjectto a fine ranging from 15 times to 30 times the value of the drugs which are illegallymanufactured, imported or sold; where the value of the drugs is less than RMB100,000,the fine shall be computed in accordance with RMB100,000; in serious cases, thedrug approval certificate shall be revoked, and the drug manufacturing permit, drugbusiness permit or medical institution preparation permit may be revoked; the incomederived by the legal representative, the principal responsible person, the personsdirectly in charge and the other persons responsible from the entity during theperiod of occurrence of the illegal act shall be confiscated, a fine ranging from30% to 300% of the income shall be imposed on these individuals simultaneously,and they shall be banned from engaging in drug manufacturing and business activitiesfor the next 10 years or permanently, and may be detained by the public securityauthorities for five days to 15 days:
manufacturing or importation of drugs withoutobtaining a drug approval certificate;
manufacturing or importation of drugs with afraudulently obtained drug approval certificate;
use of active drug ingredients which have notbeen reviewed and approved for drug manufacturing;
sale of drugs which has not been inspected asrequired;
manufacturing and sale of drugs prohibited bythe drug administrative department of the State Council;
fabrication of manufacturing, inspection records;or
making significant change in the drug manufacturingprocess without approval.
For sale of drugs stipulated in item (1) toitem (3) of the preceding paragraph, or use of drugs stipulated in item (1) to item(5) of the preceding paragraph by organizations using drugs, the offender shallbe punished pursuant to the provisions of the preceding paragraph; in serious cases,where the legal representative, the principal responsi ble person, the persons directlyin charge and the other persons responsible of the organization using drugs holda medical practitioner certificate, the medical practitioner certificate shall alsobe revoked.
Punishment imposed on offenders who import withoutapproval small quantities of drugs which have been legitimately launched in overseasmarket may be reduced or exempted in lesser cases.
Article 125 For any of the following violationsof this Law, the drugs and illegal income from illegal manufacturing and sale, aswell as packaging materials and containers thereof shall be confiscated, and theoffender shall be ordered to stop manufacturing and distribution and make correction,and be subject to a fine ranging from RMB500,000 to RMB5 million simultaneously;in serious cases, the drug approval certificate, drug manufacturing permit, drugbusiness permit shall be revoked, the legal representative, the principal responsibleperson, the persons directly in charge and the other persons responsible shall besubject to a fine ranging from RMB20,000 to RMB200,000 and may be banned 10 yearsor permanently from drug manufacturing and business activities:
conduct drug clinical trial without approval;
use packing materials or containers which comeinto direct contact with drugs when they have not been examined and approved fordrug manufacturing, or sell such drugs; or
use labels or packaging insert which have notbeen examined and approved.
Article 126 Unless otherwise stipulated in thisLaw, drug marketing authorization holders, drug manufacturing enterprises, drugbusiness enterprises, drug non-clinical safety evaluation research institutes,drug clinical trial organizations which do not comply with drug manufacturing qualitymanagement norms, drug business quality managementnorms, drug non-clinical study quality management norms, drug clinical trial qualitymanagement norms etc shall be ordered to make correction within a stipulated periodand be given a warning; where correction is not made within the stipulated period,a fine ranging from RMB100,000 to RMB500,000 shall be imposed; in serious cases,the offender shall be subject to a fine ranging from RMB500,000 to RMB2 million,and ordered to suspend manufacturing and distribution and make correction, and thedrug approval certificate, drug manufacturing permit, drug business permit etc maybe revoked; the drug non-clinical safety evaluation research institute, the drugclinical trial organization shall be banned from conducting drug non- clinical safetyevaluation study or drug clinical trial for the next five years, the income of thelegal representative, the principal responsible person, the persons directly incharge and the other persons responsible derived from the entity during the periodof occurrence of the illegal act shall be confiscated, a fine ranging from 10% to50% of the income shall be imposed on these individuals simultaneously, and theyshall be banned fromengaging in drug manufacturing and business activities for10 years to permanently.
Article 127 For any of the following violationsof this Law, the offender shall be ordered to make correction within a stipulatedperiod and be given a warning; where correction is not made within the stipulatedperiod, a fine ranging from RMB100,000 to RMB500,000 shall be imposed:
conduct bioequivalence test without completingfiling formalities;
during the drug clinical trial period, the clinicaltrial applicant fails to promptly adjust the clinical trial plan, suspend or terminateclinical trial, or fails to report to the drug administrative department of theState Council, upon discovery of safety issues or other risks;
fail to establish and implement a drug trackingsystem pursuant to the provisions;
fail to submit annual report pursuant to theprovisions;
fail to complete filing or reporting formalitiesfor changes in the drug manufacturing pursuant to the provisions;
fail to formulate a risk management plan afterlaunch of drugs to market; or
fail to carry out drug post-marketing launchstudy or post-marketing launch appraisal pursuant to the provisions.
Article 128 In addition to punishment for offencespertaining to fake drugs, inferior drugs pursuant to the law, where the drug packagingdoes not print or affix label, packaging insert is not included pursuant to theprovisions, or where the literature does not include the relevant information orthe stipulated mark pursuant to the provisions, the offender shall be ordered tomake correction and be given a warning; in serious cases, the drug registrationcertificate shall be revoked.
Article 129 Where a drug marketingauthorization holder, drug manufacturing enterprise, drug business enterpriseor medical institution violates the provisions of this Law in failure to procuredrugs from a drug marketing authorization holder or an enterprise which has drugmanufacturing or distribution qualification, it shall be ordered to make correction,the illegally procured drugs and the illegal income shall be confiscated, and afine ranging from 2 to 10 times the value of the illegally procured drugs shallbe imposed simultaneously; in serious cases, a fine ranging from 10 to 30 timesthe value of the drugs shall be imposed simultaneously, and the drug approval certificate,drug manufacturing permit, drug business permit or medical institution practicepermit shall be revoked; where the value of the drugs is less than RMB50,000, thefine shall be computed in accordance with RMB50,000.
Article 130 Where a drug business enterpriseviolates the provisions of this Law in failure to keep records for procurement andsale of drugs pursuant to the provisions, failure to state the usage, dosage ofretail drugs correctly, or failure to fill preions pursuant to the provisions,it shall be ordered to make correction and be given a warning; in serious cases,the drug business permit shall be revoked.
Article 131 Where a third party platform providerfor online drug transactions violates the provisions of this Law in failure to performobligations such as examination of qualification, reporting, cessation of onlinetransaction platform services etc, it shall be ordered to make correction, illegalincome shall be confiscated, and a fine ranging from RMB200,000 to RMB2 millionshall be imposed simultaneously; in serious cases, the third party platform providershall be ordered to suspend operation and make correction and be subject to a fineranging from RMB2 million to RMB5 million simultaneously.
Article 132 For importation of drugs for whicha drug registration certificate is obtained, where the importer fails to file recordswith the drug administrative authorities at the approved importing port pursuantto the provisions, it shall be ordered to make correction within a stipulated periodand be given a warning; where correction is not made within the stipulated period,the drug registration certificate shall be revoked.
Article 133 Where a medical institution violatesthe provisions of this Law in selling formulations prepared by the medical institutionon the market, it shall be ordered to make correction, the formulations and illegalincome from illegal sale shall be confiscated, and a fine ranging from two to fivetimes the value of the illegally sold formulations shall be imposed simultaneously;in serious cases, a fine ranging from five to 15 times the value of the formulations shall be imposed simultaneously; where the value of the formulations is less thanRMB50,000, the fine shall be computed in accordance with RMB50,000.
Article 134 Where a drug marketing authorizationholder fails to monitor adverse reactions to drugs or report suspected adverse reactionsto drugs pursuant to the provisions, it shall be ordered to make correctionwithin a stipulated period and be given a warning; where correction is not madewithin the stipulated period, it shall be ordered to suspend manufacturing and distributionand make correction, and be subject to a fine ranging from RMB100,000 to RMB1 millionsimultaneously.
Where a drug business enterprise fails to reportsuspected adverse reactions to drugs pursuant to the provisions, it shall be orderedto make correction within a stipulated period and be given a warning; where correctionis not made within the stipulated period, it shall be ordered to suspend manufacturingand distribution and make correction, and a fine ranging from RMB50,000 to RMB500,000shall be imposed simultaneously.
Where a medical institution fails to reportsuspected adverse reactions to drugs, it shall be ordered to make correction withina stipulated period and be given a warning; where correction is not made withinthe stipulated period, a fine ranging from RMB50,000 to RMB500,000 shall be imposed.
Article 135 Where a drug marketing authorizationholder is ordered by the drug administrative department of thePeople'sGovernment of the province, autonomous region or centrally-administered municipalityto recall drugs but refuses to do so, it shall be subject to a fine ranging fromfive to 10 times the value of the drugs to be recalled; where the value of the drugsis less than RMB100,000, the fine shall be computed in accordance with RMB100,000;in serious cases, the drug approval certificate, drug manufacturing permit or drugbusiness permit shall be revoked; the legal representative, the principal responsibleperson, the persons directly in charge and the other perso ns responsible shallbe subject to a fine ranging from RMB20,000 to RMB200,000. Where a drug manufacturingenterprise, drug business enterprise or medical institution refuses to cooperatein the recall of drugs, it shall be subject to a fine ranging from RMB100,000 toRMB500,000.
Article 136 Where the drug marketing authorizationholder is an overseas enterprise, and the enterprise legal person in China appointedby the drug marketing permit holder does not perform the relevant obligations pursuantto the provisions of this Law, the provisions of this Law on the legal liabilityof drug marketing permit holder shall apply.
Article 137 Any of the following acts shallbe subject to the heavier punishment within the range of punishment stipulated inthis Law:
passing narcotics, psychotropic substances,medicinal toxic drugs and radioactive drugs off as other drugs or vice versa;
producing or selling counterfeit or substandarddrugs of which the main users are pregnant and parturient women, infants and children;
manufacturing and sale of biological productswhich are fake drugs or inferior drugs;
manufacturing and sale of fake drugs or inferiordrugs which cause personal injuries;
repeat offence in manufacturing and sale offake drugs or inferior drugs; or
refuse or evade supervision and inspection,forgery, mutilation or concealment of the relevant evidential materials, or useseized or confiscated items without authorization.
Article 138 Where a drug inspection agency issuesfalse inspection reports, it shall be ordered to make correction and be given awarning, and the drug inspection agency shall be subject to a fine ranging fromRMB200,000 to RMB1 million simultaneously; the persons directly in charge and theother persons responsible shall be demoted, removed or dismissed pursuant to thelaw, illegal income shall be confiscated, and a fine of less than RMB50,000 shallbe imposed simultaneously; in serious cases, the inspection qualification shallbe revoked. Where the inspection conclusion issued by a drug inspection agency isuntrue and causes damages, it shall bear the corresponding compensation liability.
Article 139 Administrative punishment stipulatedin Article 115 to Article 138 of this Law shall be decided by the drug administrativedepartments of People's Governments of county level and above in accordance withdivision of work; revocation of permit or certificate shall be decided by the issuingauthorities of the permit or certificate.
Article 140 Where a drug marketing authorizationholder, drug manufacturing enterprise, drug business enterprise or medical institutionviolates the provisions of this Law in staff recruitment, the drug administrativeauthorities or the health administrative authorities shall order the drug marketingauthorization holder, drug manufacturing enterprise, drug business enterprise ormedical institution to dismiss the staff, and impose a fine ranging from RMB50,000to RMB200,000 thereon.
Article 141 Where a drug marketing authorizationholder, drug manufacturing enterprise, drug business enterprise or medical institutiongives or receives rebates or other improper gains in the drug procurement andsale process, or the drug marketing authorization holder, drug manufacturing enterprise,drug business enterprise or its agent gives monies or other improper gains to theperson(s)-in-charge, drug procurement staff, physicians, pharmacists etc of medicalinstitutions using their drugs, the market regulatory department shall confiscatethe illegal income and impose a fine ranging from RMB300,000 to RMB3 million simultaneously;in serious cases, the business license of the drug marketing authorization holder,drug manufacturing enterprise and drug business enterprise shall be revoked; thedrug approval certificate, drug manufacturing permit and drug business permit shallbe revoked by the drug administrative authorities.
Where a drug marketing authorization holder,drug manufacturing enterprise or drug business enterprise bribes State officialsin drug research and development process or drug manufacturing and distribution,the legal representative, the principal responsible person, the persons directlyin charge and the other persons responsible shall be banned permanently from engagingin drug manufacturing and business activities.
Article 142 Where the person(s)-in-charge, procurementstaff etc of a drug marketing authorization holder, drug manufacturing enterpriseor drug business enterprise receives monies or other improper gains in drug procurementand sale process from other drug marketing permit holders, drug manufacturing enterprises,drug business enterprises or their agents, the illegal income shall be confiscatedand punishment shall be imposed pursuant to the law; in serious cases, such individualsshall be banned from engaging in drug manufacturing and business activities forthe next five years.
Where the person(s)-in-charge, drug procurementstaff, physicians, pharmacists etc of a medical institution receives monies or otherimproper gains from a drug marketing authorization holder, drug manufacturing enterprise,drug business enterprise or its agent, the competent health administrative authoritiesor the medical institution shall impose punishment and confiscate the illegal income;in serious cases, their practitioner certificate shall be revoked.
Article 143 Persons who violate the provisionsof this Law in fabricating or disseminating false drug safety information, wherethe offence constitutes a violation of security administration, the public securityauthorities shall impose securityadministration punishment pursuant to the law.
Article 144 Where a drug marketing authorizationholder, drug manufacturing enterprise, drug business enterprise or medical institutionviolates the provisions of this Law and causes damages to users of their drugs,it shall bear compensation liability pursuant to the law.
Victims who suffer damages due to drug qualityissues may seek compensation from the drug marketing permit holder and the drugmanufacturing enterprise, and may also seek compensation from the drug businessenterprise and medical institution. Upon receipt of compensation claim from a victim,the entity shall compensate first; after the compensation, it may seek recoveryon the compensation pursuant to the law.
For manufacturing fake drugs or inferior drugsor engaging in sale or use of fake drugs or inferior drugs knowingly, in additionto seeking compensation, the victims or their immediate family members may alsoseek indemnity based on 10 times of the payment amount or three times of the damages;where the additional compensation amount is less than RMB1,000, it shall be roundedup to RMB1,000.
Article 145 Where a drug administrative departmentor the professional technical organization for drugs established or appointed bythe drug administrative department participate in drug manufacturing and businessactivities, it shall be ordered by its higher-level competent administrative departmentto make correction, and its illegal income shall be confiscated; in serious cases,the directly-accountable person-in-charge and other directly-accountable personnelshall be punished pursuant to the law.
Where the staff of a drug administrative departmentor the professional technical organization for drugs established or appointed bythe drug administrative department participate in drug manufacturing and businessactivities, they shall be punished pursuant to the law.
Article 146 Where a drug administrative departmentor the drug inspection agency established or appointed by the drug administrativedepartment collects inspection fees illegally for supervision and inspection ofdrugs, the relevant government department shall order it to make refund, and punishthe directly-accountable person-in-charge and other directly-accountable personnelpursuant to the law; in serious cases, the inspection qualification shall be revoked.
Article 147 Where a drug administrative departmentviolates the provisions of this Law in committing any of the following acts, therelevant permit shall be revoked, and the persons directly in charge and the otherpersons responsible shall be punished pursuant to the law:
approves drug clinical trials which do not satisfythe criteria;
issues drug registration certificates for drugswhich do not satisfy the criteria; or
issues drug manufacturing permit, drug businesspermit or medical institution preparation permit to organizations which do not satisfythe criteria.
Article 148 Where a People's Government of countylevel and above violates the provisions of this Law in committing any of thefollowing acts, the persons directly in charge and the other persons responsibleshall be given a demerit or serious demerit;
in serious cases, such individuals shall bedemoted, removed or dismissed:
conceal, delay or omit reporting of drug safetyincident or make false reporting of drug safety incident;
fail to promptly eliminate regional seriousdrug safety hazards and causes a very serious drug safety incident within theiradministrative region or recurrent serious drug safety incidents; or
incompetent performance of duties which causesserious adverse impact or serious losses.
Article 149 Where a drug administrative departmentetc violates the provisions of this Law in committing any of the following acts,the persons directly in charge and the other persons responsible shall be recordeda demerit or serious demerit; in relatively serious cases, such individuals shallbe demoted or removed; in serious cases, such individual shall be dismissed:
conceal, delay, omit or make false reportingof drug safety incident;
fail to promptly investigate and deal with adrug safety violation upon discovery of such violation;
fail to promptly discover systemic risks ofdrug safety, or fail to promptly eliminate drug safety hazards within their supervisionand administration region, resulting in serious consequences; or
fail to perform drug supervision and administrationduties, resulting in serious adverse impact or serious losses.
Article 150 Drug supervision and administrationofficers guilty of abusing official powers, corruption and practicing favoritism,dereliction of duties shall be punished pursuant to the law.
Where the directly-accountable person-in-chargeand other directly-accountable personnel of a drug administrative department commitdereliction of duties or malfeasance in the investigation and punishment of illegalacts involving fake drugs or inferior drugs, they shall be subject to heavy punishmentpursuant to the law.
Article 151 The value of goods stipulated inthis Chapter shall be computed in accordance with the pricing of the illegallymanufacturedand sold drugs; where there is no pricing, the computation shall be based on themarket prices of the same type of drugs.

Chapter 12 SupplementaryProvisions

Article 152 The cultivation, harvest and feedingof Chinese herbal medicine shall be regulated in accordance with provisions of applicablelaws and administrative regulations.
Article 153 Measures for the management of thefolk crude drugs customarily used in certain regions shall be provided by the drugadministrative department together with the competent department for traditionalChinese medicines under the State Council.
Article 154 Specific measures for enforcementof this Law by the Chinese People’s Liberation Army and Chinese Armed Police Forceshall be formulated by the State Council and Central Military Commission in accordancewith this Law.
Article 155 This Law shall be implemented witheffect from 1 December 2019.

Chapter 1 General Principles
Chapter 2 Drug Research and Development and Registration
Chapter 3 Drug Marketing Authorization Holder
Chapter 4 Drug Manufacturing
Chapter 5 Drug Distribution
Chapter 6 Pharmacy Administration of Medical Institutions
Chapter 7 Drug Post-marketing Management
Chapter 8 Drug Pricing and Advertising
Chapter 9 Drug Reserve and Supply
Chapter 10 Supervision and Administration
Chapter 11 Legal Liability
Chapter 12 Supplementary Provisions

中华人民共和国药品管理法

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Drug Administration Law of the People's Republicof China (2019 Revision)

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