Active pharmaceutical ingredients (API) in China: Approval process, timelines, practice points

INTRODUCTION
Active pharmaceutical ingredient (API) application pathways in China have evolved substantially over the past 5 years. In 2018, the drug master file (DMF) system was introduced, superseding the previous approval procedure, which had been in place for more than ten years, and which was similar to that of finished drugs and therefore very costly and time-consuming for applicants. See Figure 1 for a timeline of recent key regulatory changes.

This paper reviews key application requirements and approval pathways for API in China, and explores challenges and key practice points for applicants.

REGULATORY FRAMEWORK
The SAMR (State Administration for Market Regulation) and NMPA (National Medical Products Administration) – former CFDA (China Food and Drug Administration) – are responsible for the management and registration of pharmaceutical products as well as medical devices, in-vitro diagnostics and cosmetics in China. The CDE (Center for Drug Evaluation) is NMPA’s specific department responsible for the registration of pharmaceutical products.