An overview of the revised drug regulations, application process, and the requirements for the post-approval CMC amendments in China is presented in this article. The National Medical Products Administration (NMPA) is the regulatory authority in China that is responsible for evaluation of the new drug registration applications and the amendments during the life cycle of the drug.
NMPA launched the revised Drug Registration Regulations (DRR) from July 2020 through 2024. This is the first major revision of the drug regulations in China since 2007 and has significant impact on how the new drug registration applications and life cycle amendments are filed and evaluated by the NMPA.
China’s adaptation to ICH and a comparison with US FDA, EMA, and PMDA regulations is discussed.
