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

by cyb2025
H. King
API
China DMF
China regulatory affairs
Registration practice points

HAMISH KING
Cisema Hong Kong, China

ABSTRACT

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

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.

ABOUT THE AUTHOR

Hamish King is COO at Cisema, a China-focused CRO and regulatory consultancy founded in Munich and Beijing in 2002. A lawyer by training – admitted in Hong Kong and NSW, Australia – Hamish previously worked with UK “magic circle” firm Linklaters in Hong Kong, and has nearly 10 years’ experience in the legal and regulatory fields. He has obtained the RAC and CFA qualifications. Regularly writing articles and speaking on China regulatory affairs and pathways for life sciences products, Hamish lives in Hong Kong.

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