On May 15, 2026, China’s National Medical Products Administration (“NMPA”) issued the Implementation Measures for Drug Trial Data Protection (the “Measures”), effective immediately, to formalize China’s protection regime for eligible undisclosed chemistry, manufacturing and control (CMC) and clinical study data submitted in marketing authorization applications. The Measures define the eligible products, protection periods, application process, publication mechanism, and restrictions on follow-on applications that rely on protected data.

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