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China Opens Up Non-End-To-End Manufacturing Of Biologics Within, Across Border

19 Nov 2024

• By Xu Hu

China implements a new pilot scheme allowing non-end-to-end manufacturing of certain biologics before possible nationwide implementation for all such products, with resource optimization and aligned quality management systems among the main goals.

New rules shift — China's NMPA launched a pilot program of non-end-to-end manufacturing of certain biologics due at the end of 2026. (Shutterstock)

China’s National Medical Products Administration (NMPA) announced on 21 October the work plan for a pilot program to allow the non-end-to-end manufacturing of a broad range of biologic pharmaceuticals.

Its scope includes innovative drugs, those with urgent clinical needs and NMPA-designated products such as multivalent vaccines, antibodies, antibody-drug conjugates...