In the tumultuous year of 2020, the COVID-19 pandemic did not appear to hinder the progress of regulatory reform and new drug approvals in China. The National Medical Products Administration (NMPA) continued to implement many regulations and guidelines. The number of drug applications and the timeline of review and approval were not negatively impacted.
A total of 46 new drugs were approved in 2020 (less than the 53 approved in 2019), including 28 chemical drugs and 18 biological products. In this article, “new drug” is defined as innovative chemical drugs and biological products approved for the first time in China, and drugs already approved outside China but approved in China for the first time.