New Progress in the Key Projects of the Action Plan for Drug Regulatory Science in China

  • 2021-12-10
According to recent news of the National Medical Products Administration (“NMPA”), the first group of key projects of the Action Plan for Drug Regulatory Science in China has made new progress, specifically, since launch, 45 among the 101 new tools, new methods and new standards studied and developed have been released and applied in drug regulation by the end of this October. 

In April 2019, the NMPA launched the first group of nine key research projects of the Action Plan for Drug Regulatory Science in China by centering on the drugs, medical devices and cosmetics regulation requirements in the new period and keeping a close eye on new industry, new technology and new product development in the world. Those key research projects have fruited, and the release of fruits including the Review Points for CT Images-assisted Pneumonia Triage and Assessment Software (for Trial Implementation) provides strong support for product innovative R&D and regulation and contributes to the winning of the battle of COVID-19 prevention and control. The NMPA continues to advance regulatory science research in the areas of drugs, medical devices, and cosmetics this year, and there has been further good news. 

The Technical Guidelines for Studies of Post-Approval CMC Changes to Traditional Chinese Medicines (for Trial Implementation) was released in April 2021, which is one of the supporting documents of the new edition of Provisions for Drug Registration, represents a result of the “TCM clinical practice-oriented TCM safety evaluation research” of the key projects of the Action Plan for Drug Regulatory Science in China, absorbs the experience of TCM production process change studies in recent decades, draws on international advanced concepts of drug change management, and further improves the review standard system in line with TCM characteristics. This project pooled the wisdom and strength of the regulator, the China Academy of Chinese Medical Sciences, etc., conducted research from dimensions including standard preparation, technical review, and inspection, and produced 11 new tools, methods and standards including the Technical Requirements for Quality Control and Standard Setting of Traditional Chinese Medicine Formula Granules and the Technical Guidelines for Studies of Quality Control of New Medicinal Materials of Traditional Chinese Medicine, to provide strong support to promote TCM innovation based on tradition, improve the review and approval system in line with TCM characteristics, and strengthen TCM quality safety regulation. 

Guided by the Review Points for Aided Decision-making Medical Device Software Using Deep Learning, there have been more than 20 kinds of Class III AI-based software as a medical device (SaMD) approved for marketing. With the accumulation of experience in regulation over AI-based medical devices, the Guiding Principles for Review of Registration of AI-based Medical Devices (Exposure Draft) was released in June 2021 to solicit opinions from society and has now been applied for approval and release for implementation, and the guiding principles for specific products are being developed. 

The NMPA issued the Notice on Matters Concerning the Registration of Drug-Device Combination Products (hereinafter referred to as the Notice) in July 2021, and the Center for Medical Device Evaluation, NMPA solicited opinions on the Guiding Principles for Review of Registration of Drug-Device Combinations (Exposure Draft) from society in the same period. Under the background of the reform of the review and approval system and the emergence of innovative combination products in China, the Notice has timely adjusted the marketing certificate requirements for such products and modified the attribute definition content, representing a result of the “drug-device combination product technical evaluation research” of the key projects of the Action Plan for Drug Regulatory Science in China. It is learned that during the advancement of the project, the project team decomposed nine subtasks and defined eight time points, and the participating entities researched the regulation and technical evaluation difficulties, drew on international regulatory experience, combined with the reality of China, and put forward suggestions for regulation. 

The key project in the area of cosmetics has also made a breakthrough, to boost the development of the cosmetics regulatory system and technical support capacity and the unleashing of benefits from the reform. The NMPA completed the filing of four new cosmetic raw materials including N-acetylneuraminic acid in June this year, which has greatly shortened the time to market of new raw materials and injected vitality for innovation in the cosmetics industry. 

The achievement of the series of results would be impossible without the thorough arrangements of and advancement from the high level by the NMPA. Since the launch of the first group of key projects, the NMPA has prepared the plan for division of work, defined the project leading and implementing entities and main cooperative entities, guided the entities to accomplish coordination, management, and research, and regularly held project advancement meetings to require strict project management, assessment and acceptance. As a result, all the work has proceeded orderly, and the Action Plan for Drug Regulatory Science in China has been thoroughly advanced. Based on the present, taking into account the long-term development, and oriented toward solving problems, the NMPA is committed to promoting the Action Plan for Drug Regulatory Science in China to enter into a new stage to meet the public’s health demand. The NMPA, based on a systematic summary of the implementation of the first group of key projects, released the second group of 10 key projects of the Action Plan for Drug Regulatory Science in China in June this year. The implementation plan has been prepared for each project so far, and the leading and implementing entities are accelerating innovation according to the principle of focusing on the frontiers, highlighting priorities, strengthening actual effects, and advancing steadily. 

The NMPA will next overall advance the development of regulatory science research bases and key laboratories, include drug regulatory science research in the related national science and technology plans, focus on supporting regulatory science research in areas of TCM, vaccines, gene-based drugs, cell drugs, AI-based medical devices, new medical device materials, and new cosmetics raw materials, and accelerate the marketing of new products. 

Source: China Pharmaceutical News