China’s National Medical Products Administration (NMPA) has issued new implementation measures formalising protection for eligible undisclosed drug trial data submitted in marketing authorisation applications in China.

• Data Protection: The measures provide protection periods of up to six years for eligible chemistry, manufacturing and control (CMC) and clinical study data used in drug approval applications.
• Effective Date: The Implementation Measures for Drug Trial Data Protection took effect on 15 May 2026.
• Regulatory Scope: The measures apply to eligible chemical drugs and biological products approved in China and set rules covering application procedures, publication mechanisms, and restrictions on follow-on applications relying on protected data.

This summary is based on a news article issued by BioSpectrum Asia.

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