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

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 (ADCs), GLP-1 agonists and insulin.

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Xu Hu

Read more by Xu Hu

Xu is a senior reporter and covers aspects on policy and regulations in China pharma industry within the APAC Pharma news team.

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