The Provisions for Drug Registration was reviewed and adopted by the first executive meeting of State Administration for Market Regulation in 2020 on January 15, 2020, and will come into force on July 1, 2020.

The new Registration has been comprehensively revised in the 2007 version, innovating in the concept of drug supervision, introducing the concept of full lifecycle management of drugs, and designing a system to strengthen the regulatory system throughout the entire process from drug development and marketing, post marketing management, to drug registration and certificate cancellation.

In accordance with the requirements of the State Council for simplifying policies and delegating management to lower levels, new Registration has created a new drug registration management method: the first is to establish a related review and approval system; the second is to implement an implied licensing system for the approval of drug clinical trials, and to replace the original licensing system with a filing system for bioequivalence trials; the third is to implement classified management of drug changes; fourthly, implement a risk based evaluation, verification, and inspection model based on the level of product innovation and risk characteristics; the fifth is to scientifically establish the drug registration and inspection process, and adjust the drug registration and inspection to be initiated before acceptance; the sixth is to strengthen supervision during and after the event, emphasize the continuous compliance of research and development behavior, strictly enforce post market research management requirements, strengthen information disclosure and social supervision, and strengthen drug lifecycle management.

Compared with the 2007 version, many new concepts and institutional designs have been introduced. For example, new systems such as the holder system for drug marketing licenses, implied license for drug clinical trials, priority review and approval, review and approval of raw and auxiliary packaging and formulation associations, communication and exchange, and expert consultation. The new version of the "Regulation" has comprehensively optimized and upgraded the existing system to meet the requirements of the reform of the drug review and approval system, as well as the needs of scientific progress and rapid development of the pharmaceutical industry.