There was a notable surge in the acceptance of drug registration applications in 2023
In recent years, a plethora of policies aimed at fostering pharmaceutical innovation have persistently stimulated the vitality of industrial innovation, leading to a steady surge in the number of drug registration applications throughout 2023.According to the report, in 2023, the Center for Drug Evaluation accepted a total of 18,503 registration, with a a significant rise (35.84% compared to the last year). Specifically, 16,898 registrations were for drug formulations, reflecting a 36.63% year-on-year increase, while 1,605 applications were for chemical raw materials, marking a 28.09% rise from the preceding year.
In the realm of drug formulation registration applications, two primary categories exist: technical evaluation and direct administrative approval. In the latest reporting period, there were 13,153 technical evaluation registration applications, marking a notable year-on-year surge of 41.41%. Additionally, there were 3,745 direct administrative approval registration, reflecting a solid increase of 22.11% compared to the previous year.
Drug formulation registration applications include technical evaluation and direct administrative approval registration applications, of which 13153 were technical evaluation registration applications, a year-on-year increase of 41.41%;There were 3745 direct administrative approval registration applications, an increase of 22.11% year-on-year.
In 2023, the growth rate of traditional Chinese medicine registration applications is remarkable. The Centre for Drug Evaluation received a total of 1163 registration applications for traditional Chinese medicine technology evaluation throughout the year, a year-on-year increase of 176.25%. 9813 chemical drug registration applications were submitted, an increase of 39.11% year-on-year, accounting for 74.66% of the total number of drug registration applications that require technical evaluation; 2168 applications for registration of biological products increased by 19.12% year-on-year.
In 2023, the Centre for Drug Evaluation received 2997 new drug clinical trial applications (INDs) throughout the year, marking a substantial increase of 33.56% compared to the previous year; 170 confirmatory clinical trial applications, an increase of 32.81% from 2022; 470 new drug marketing authorization applications (referred to as "NDAs") increased by 40.72% year-on-year; Furthermore, 3852 applications for marketing authorization of drugs with the same name and formula, as well as chemical generic drugs (referred to as "ANDA"), an increase of 66.25% year-on-year;There were 1006 applications for consistency evaluation of generic drug quality and efficacy (referred to as "consistency evaluation applications"), an increase of 20.48% compared to last year; 4115 supplementary applications, a year-on-year increase of 36.26%; 534 applications for re registration of drugs produced overseas increased by 28.06% year-on-year.
Emerging therapies are steadily maturing, with evaluations persistently emphasizing both novel and efficacious drugs.
It is reported that the Centre for Drug Evaluation is continuously deepening the reform of drug review and approval, improving and accelerating the listing and registration procedures, ensuring that review resources continue to tilt towards clinically urgently needed and clinically advantageous products, strengthening communication and interaction with applicants, shortening drug research and development and technical review time, and focusing on promoting the accelerated listing of clinically urgently needed drugs.
The report indicates that in 2023, a total of 40 Class 1 innovative drugs will receive approval for marketing. Among these, 9 will undergo approval via the priority review process, while 13 will be granted marketing approval with specific conditions attached. Additionally, 8 drugs will enter the breakthrough therapeutic drug pathway during the clinical research phase, and 4 COVID-19 therapeutic drugs will be approved through a specialized expedited procedure.In recent years, significant advancements have been achieved in both basic research and the practical application of novel mechanisms and target drugs. This progress is exemplified by the increasing maturity of next-generation therapies such as cell therapy, gene therapy, and small nucleic acid drugs.
In 2023, a notable milestone was reached in the pharmaceutical landscape with the approval of 891 therapeutic bioproducts, marking a significant increase from the previous year. Among these approvals, 695 were deemed innovative therapeutic bioproducts, showcasing a diverse range of 510 varieties, representing a remarkable year-on-year growth of 25.68%. Furthermore, there was a commendable surge in the approval of New Drug Applications (NDAs), with 32 therapeutic biological products receiving the green light, including 19 innovative varieties, reflecting a remarkable year-on-year increase of 111.11%. In response to the pressing healthcare needs of both the general public and specific demographics, a total of 45 rare disease drugs were granted approval throughout the year. Excluding rare disease drugs falling under the four categories of chemical compounds, this approval included 15 products expedited to market through priority review and approval procedures, with one variety receiving conditional approval for market distribution.Moreover, 92 of children's medication products gained approval over the course of the year, with 72 successful marketing approval applications. Notably, 26 were fast-tracked to market through priority review and approval procedures, underscoring a concerted effort to address pediatric healthcare needs in a timely manner.
Another 20 varieties are approved to expand the indications for children, benefiting more pediatric patients and millions of families. Last year, the Centre for Drug Evaluation formulated and released technical guidelines for the application of physiological pharmacokinetic models in pediatric drug development, as well as quantitative methodological guidelines for extrapolating adult drug use data to pediatric populations (trial) and other guidelines applicable to pediatric drug use; In order to solve the difficulty of swallowing medication for special groups, the Technical Guidelines for Quality Attribute Research of Chewable Tablets (Chemical Drugs) (Trial) have been formulated and released to further accelerate the research and development process of medication for children and special populations. In addition, for the whole year of 2023, 86 varieties of original research drugs that have been listed overseas but not domestically were approved, of which 62 were newly approved for marketing, including 1 variety included in the list of urgently needed overseas new drugs for clinical use, and 24 new indications, providing patients with more safe, effective, and quality controlled clinical drugs for treating serious life-threatening diseases and responding to public health.
Actively carry out drug research and development, technical evaluation, publicity, and training
In 2023, the Centre for Drug Evaluation promptly sorted out the drug review policies, regulations, technical guidelines, and process management consulting, addressing pressing that enterprises are concerned about. It conducted 12 online training sessions on specific topics, reaching a audience of over 110000 people, focusing on explaining the review business.
The center systematically explained communication and exchange, registration acceptance and electronic declaration, verification and inspection, routine review processes, accelerated review processes, and written supplements during the review process. The center provided applicants with concepts, requirements, problems, and practical operations, covering the entire process of drug registration business; Promoting the research and development of innovative drugs, traditional Chinese medicine inheritance and innovation, clinical urgent drug research and development and other related policies and regulations, reform achievements, technical guidance principles, etc., actively disseminating new measures and methods encouraged by the center to the outside world, stimulating the research and development momentum of China's pharmaceutical industry, and promoting new drug research and development and registration applications.
In service of the national and regional development strategies, the centre has focused on industry concerns and conducted 12 offline training sessions with nearly 8000 participants.
In the Beijing-Tianjin-Hebei region, the centre held training courses on ICH E6 (R3): Good Clinical Practice for Drug Trial Quality Management and anti-tumor innovative drugs. They also traveled to the Yangtze River Delta and the Greater Bay Area to conduct training meetings on "Guiding Principles for Clinical Research and Development Technology of Cell and Gene Therapy Products", "Chemical New Drug Communication and Exchange Training Meetings", "Special Regulations for Traditional Chinese Medicine Registration Management Training Courses", and "Technical Guidance Training Meetings for Biological Product Change Management".
Furthermore, the centre went to Liaoning, Jilin, and Heilongjiang to carry out a series of drug registration technology training courses to support the development of the pharmaceutical industry in Northeast China. In collaboration with the three provincial bureaus of Liaoning, Jilin, and Heilongjiang, centre jointly hosted three special topics on chemical medicine, biological products, and traditional Chinese medicine. In strict accordance with the requirements of "early intervention, one enterprise, one policy, full process guidance, and research and review linkage", we innovatively integrated drug registration technology training with enterprise symposiums. This approach provided targeted training and guidance for key varieties and key pharmaceutical enterprises in Northeast China, helping to revitalize the innovation and high-quality development of the biopharmaceutical industry in the region.
