It is a critical step for overseas drug applicants to choose a right registration classification for marketing authorization in China. Only after determining the product's registration class, and with knowledge of corresponding fees and application dossier requirements, applicants can get on the right track for registration.
Applicants can also evaluate the product to see if it is qualified for expedited programs for drug marketing approval.1
This article is expected to help you understand how China NMPA classifies chemical drugs. For biological product registration classification, please click here.
You can also sign up at ChemLinked BaiPharm portal and watch our webinar Drug Registration Classification System in China.
1. Chemical Drug Registration Classification
The Chemical Drug Registration Classification and Application Dossier Requirements2 released by National Medical Products Administration (NMPA) took effect on Oct. 1, 2020. The regulation specified the five registration classes of chemical drugs:
