On March 30, the State Administration for Market Regulation (SAMR) promulgated the Provisions for Drug Registration by Order No. 27, and the Provisions for the Supervision and Administration of Drug Production by Order No. 28, which shall be officially implemented from July 1, 2020. 

The Party Committees of SAMR and NMPA have, heretofore, reviewed and revised the Drafts for Deliberation of the above Provisions pursuant to the Legislation Law of the People's Republic of China, the Provisions for Drafting Procedures of Rules & Regulations, and the SAMR Provisions for Drafting Procedures of Rules & Regulations; per the latest requirements of the newly enforcedVaccine Administration Law of the People's Republic of China and the newly revised Drug Administration Law; and on the basis of seriously implementing the decisions and deployment of the CPC Party Central Committee and the State Council on drug & vaccine regulatory reform, and adhering to the law-based reform consensus to promote various reforms and innovations in the field of drugs. In the process of drafting and reviewing, we adhered to the requirements of scientific, democratic, and law-based legislation, and listened to opinions and suggestions extensively. Aiming at the key and difficult issues in the revision, expert evaluations are specially organized to fully conduct research and demonstration. On January 15, the above two regulations were reviewed and approved by the 1st SAMR executive meeting in 2020. 

In the drafting and revision process, four basic ideas were followed: First, adhere to the Four Strictest (Strictest Standards, Regulation, Punishment, and Accountability) requirements to regulate drug registration and production, strengthen the whole-process regulation, strictly prevent and control drug quality and safety risks, and firmly adhere to the bottom line of safeguarding public safety. Second, deepen reform and innovation to fully implement the Marketing Authorization Holder management system, encourage drug innovation, continue to optimize the drug registration review & approval system and drug production permit system, and build a scientific and efficient review & approval process. Third, highlight the people-centered, problem-oriented approach to draw on international regulatory practice and experience while taking into account the domestic situation, focus on solving the prominent issues in drug registration and production supervision, clarify the scope and expedite the marketing registration for short supplied, clinically urgently-needed drugs, pediatric drugs, orphan drugs, drugs against major infectious diseases, and urgently-needed vaccines for disease prevention & control. Specific requirements shall be made to ensure sustained compliance in pharmaceutical production. Fourth, strengthen accountability to strictly implement corporate principal responsibility and regulatory responsibilities, refine corporate obligations in drug R&D, registration, production and other links; and clarify the division of powers amongst regulatory authorities and the corresponding inspection requirements. 

The revision of the two Provisions, which are the core supporting regulations in the field of drug supervision, will lay the foundation for the rule of law to strengthen drug quality and safety risk control, standardize and strengthen drug supervision, and ensure drug safety, effectiveness and quality control.