On May 15, 2026, China’s National Medical Products Administration (NMPA) successively released the Implementation Measures for Drug Trial Data Protection and an Interpretation of the same.

The Measures effective May 15, 2026, providing equal drug trial data protection terms for domestic and foreign-developed drugs. The data protection scope includes all test data used in the drug marketing authorization application to demonstrate the safety, efficacy, and quality controllability of the drug.  During the data protection period, the NMPA will not approve any marketing authorization applications or supplemental applications for improved new drugs, generic chemical drugs, or biosimilars submitted by other applicants without the holder’s consent and relying on the holder’s protected data. The Interpretation provides more details on the Measures, such as what is test data used to prove the safety, efficacy and quality controllability of drugs and is new clinical trial data protected for conditionally approved drugs.

                                                                                                                   Source. National Medical Products Administration