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.
Link to Key Requirements and Practical Impact Key Requirements and Practical Impact
The Measures apply to eligible chemical drugs and biological products approved in China, and they protect complete, non-public CMC and clinical study data that the applicant independently obtained and first used in China for a marketing authorization application. The maximum protection period is six years and runs from the date the marketing authorization is approved in China.
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