The General Office of the State Council recently issued the "Opinions on Fully Deepening the Reform of Drug and Medical Device Supervision and Promoting the High Quality Development of the Pharmaceutical Industry" (hereinafter referred to as the "Opinions").

The Opinion proposes that by 2027, the legal and regulatory system for the supervision of drugs and medical devices will be more perfect, and the regulatory system, mechanism, and methods will better adapt to the needs of pharmaceutical innovation and high-quality industrial development. The quality and efficiency of the review and approval of innovative drugs and medical devices will be significantly improved, and the supervision of the entire life cycle will be significantly strengthened. The quality and safety level will be comprehensively improved, and a regulatory system that is compatible with pharmaceutical innovation and industrial development will be established. By 2035, the quality, safety, effectiveness, and accessibility of drugs and medical devices will be fully guaranteed, and the pharmaceutical industry will have stronger innovation creativity and global competitiveness, basically achieving regulatory modernization.

The Opinion specifies 24 reform measures in 5 aspects. One is to increase support for the research and innovation of drugs and medical devices. Improve the review and approval mechanism to fully support major innovations, increase support for traditional Chinese medicine research and development innovation, give full play to the leading role of standards in drug and medical device innovation, improve the relevant systems for intellectual property protection of drugs and medical devices, and actively support the promotion and use of innovative drugs and medical devices. The second is to improve the quality and efficiency of drug and medical device evaluation and approval. Strengthen the pre registration guidance for drugs and medical devices, accelerate the approval and listing of urgently needed clinical drugs and medical devices, optimize the clinical trial review and approval mechanism, drug supplementary application review and approval, and drug and medical device registration inspection, and accelerate the review and approval of rare disease drugs and medical devices. The third is to enhance the compliance level of the pharmaceutical industry through efficient and strict supervision. Promote the authorization of batch issuance of biological products (vaccines), enhance the quality of generic drugs, promote the informatization of production and inspection processes in pharmaceutical enterprises, improve the efficiency of drug and medical device supervision and inspection, strengthen the vigilance of innovative drugs and medical devices, and improve the quality and efficiency of supervision of new forms of pharmaceutical circulation. The fourth is to support the pharmaceutical industry in expanding its opening-up and cooperation with the outside world. Deepen the transformation and implementation of international general regulatory rules, explore the segmented production mode of biological products, optimize the import approval of drugs and medical devices, and support the export trade of drugs and medical devices. The fifth is to establish a regulatory system that adapts to industrial development and safety needs. Continuously strengthen regulatory capacity building, vigorously develop scientific drug regulation, and enhance regulatory informatization construction.