As part of its continuing effort to align its regulatory approach to drug registration and regulation with international practices, China is proposing modifications to the way it categorizes pharmaceuticals.
The draft plans would be the first restructuring of registration classifications of chemical drugs since 2016 and of biologics and vaccines since 2007. Chinese authorities are seeking feedback on the draft plans through the end of June.
Under a draft plan issued in May by China’s National Medical Products Administration (NMPA), therapeutic biologics drugs and vaccines would be separated into three broad categories instead of the current 15. Drugs not approved for use outside China would make up one of the three categories.
Also, for chemical drugs, the NMPA will further define innovative drugs verse generics.