On March 30, the State Administration for Market Regulation announced the "Administrative Measures for Drug Registration" by Order No. 27 of the General Administration and the "Administrative Measures for the Supervision and Administration of Drug Production" by Order 28. The two regulations will be officially implemented on July 1, 2020.

The quality and safety of medicines are closely related to the health of the people. General Secretary Xi Jinping emphasized that the responsibility for drug safety is more important than Mount Tai, and requires that the supervision of drug quality and safety be strengthened in accordance with the "four strictest". Premier Li Keqiang called for the establishment of the strictest drug safety supervision system. The Party Central Committee and the State Council issued the "Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices" (Ting Zi [2017] No. 42) and other important documents to make major reform arrangements for the drug review and approval system. In June 2019, the Standing Committee of the National People's Congress deliberated and passed the Vaccine Management Law; in August, it deliberated and passed the newly revised Drug Management Law. In accordance with the latest requirements of the two laws, the State Food and Drug Administration has stepped up the revision and drafting of supporting regulations such as the Measures for the Administration of Drug Registration and the Measures for the Supervision and Administration of Drug Production, and submitted the revised drafts of the two regulations for review on November 29 The draft is submitted to the State Administration for Market Regulation for review.

The Party Group of the State Administration for Market Regulation and the Party Group of the State Food and Drug Administration earnestly implement the decisions and deployments of the Party Central Committee and the State Council on drug and vaccine regulatory reforms, adhere to the rule of law to build consensus on reforms, promote various reforms and innovations in the drug sector on the track of the rule of law, and implement new formulations The latest requirements of the “Vaccine Administration Law” and the newly revised “Drug Administration Law”, in accordance with the “Legislative Law”, “Regulations on the Procedure of Regulations” and “Regulations on the Procedure of Regulations of the State Administration for Market Regulation”, the drafts of the two regulations were submitted for review. Reviewed and revised. In the process of drafting and review, adhere to the requirements of scientific legislation, democratic legislation, and law-based legislation, and extensively listen to opinions and suggestions. In view of the key and difficult issues in the revision, experts are specially organized to evaluate and fully conduct research and demonstration. On January 15, the first administrative meeting of the General Administration of China in 2020 reviewed and approved the above two regulations.

The basic ideas followed in the drafting and revision process: First, adhere to the "four strictest." Strict drug registration management and drug production supervision, strengthen supervision of the whole process, strictly prevent and control drug quality and safety risks, and firmly maintain the bottom line of public safety. The second is to deepen reform and innovation. Fully implement the marketing authorization holder management system, encourage drug innovation, continue to optimize the drug registration review and approval system and the drug production license system, and build a scientific and efficient review and approval process. The third is to highlight the problem orientation. Adhere to the people-centered approach, learn from the practical experience of international supervision, and combine with domestic supervision practices to focus on solving outstanding problems in drug registration and drug production supervision. The clinically urgently needed drugs, drugs for children, drugs for rare diseases, drugs for major infectious diseases, and diseases Vaccines urgently needed for prevention and control and innovative vaccines are clearly included in the scope of accelerated listing and registration. Put forward clear requirements for continuous compliance in drug production. The fourth is to strengthen the implementation of responsibilities. Strictly implement the main responsibility and supervisory responsibility of enterprises, refine the obligations of drug development, registration, and production, and clarify the division of powers and supervision and inspection requirements of the supervisory department.

The main contents of the amendments include: First, fully implement the drug marketing authorization holder system. It is clear that the applicant is an enterprise or drug research and development institution that can bear corresponding responsibilities, and requires the establishment of a drug quality assurance system, management of the entire life cycle of the drug, post-marketing research, and responsibility for the safety, effectiveness and quality of the listed drug. The second is to optimize the review and approval workflow. Do a good job in the connection of drug registration acceptance, review, verification and inspection, change the original review, verification and inspection from "series" to "parallel", establish breakthrough therapeutic drugs, conditional approval, and priority review The four accelerated channels for approval and special approval have clarified the review time limit, and improved the efficiency of drug registration and the expectation of the registration time limit. In accordance with the principles of risk management, the requirements of “delegation, management and service” were implemented, and classified management of changes was implemented. The third is to implement full life cycle management requirements. Strengthen drug development, registration and post-marketing supervision. Increase the supervision of drug non-clinical research institutions, drug clinical trial institutions and relevant requirements for drug safety credit files. Pay attention to the organic connection between registration and production license, implement the regulatory requirements of drug production quality management, clarify inspection procedures and follow-up measures for inspection results. Actively promote social co-governance, require public review conclusions and basis, and accept social supervision. The fourth is to strengthen accountability. Refine penalties, severely crack down on data fraud and other violations of laws and regulations, and create a good environment that encourages innovation.

As the core supporting regulations in the field of drug supervision, the revision of the two regulations will lay a legal foundation for strengthening drug quality and safety risk control, standardizing and strengthening drug supervision, and ensuring drug safety, effectiveness and quality control. In the next step, the State Food and Drug Administration will promptly formulate supporting documents to ensure that various regulations are implemented, effectively improve the quality of drugs, and ensure that drugs are safe, effective, and accessible.