China Tightens Obligations of CMOs in Drug Contract Manufacturing

On 6 January 2026, the National Medical Products Administration (“NMPA”) released the Announcement on Strengthening the Supervision and Administration of Drug Contract Manufacturing (“Announcement”), with immediate effect. This Announcement builds upon the Marketing Authorization Holder (“MAH”) system established by the 2019 Drug Administration Law, and reinforced by the Provisions for the Supervision and Administration of Marketing Authorization Holders’ Implementation of Their Responsibilities for Drug Quality and Safety (“MAH Provisions”) in 2022 and the Announcement on Strengthening the Supervision and Administration of Contract Manufacturing by MAHs (“Announcement No. 132”) in October 2023. The new Announcement aims to ensure that both MAHs and Contract Manufacturing Organizations (“CMOs”) jointly uphold their obligations to safeguard drug quality.

This evolution is further reinforced by the revised Implementing Regulations of the Drug Administration Law, to be effective from 1 May 2026, in terms of segmented contract manufacturing. Thus, the release of this Announcement serves as a necessary response to address the increasing regulatory demands arising from this legislative development

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