To promote drug innovation and improve the system for the drug trial data protection, the National Medical Products Administration (NMPA) has, in accordance with the Drug Administration Law of the People’s Republic of China, the Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China and other relevant provisions, and by drawing on international experience, formulated the Implementation Measures for Drug Trial Data Protection (hereinafter referred to as "the Implementation Measures"). The Implementation Measures are hereby issued and shall come into force as of the date of issuance. The relevant matters are hereby announced as follows:

I. As of the date of issuance of this Announcement, applicants for drug registration may file an application for drug trial data protection simultaneously with their drug registration applications.

II. For drug registration applications that have been accepted prior to the date of this announcement but remain under review, if the conditions for granting drug trial data protection under the Implementation Measures are met, the applicant shall file an application for drug trial data protection with the Center for Drug Evaluation of the National Medical Products Administration (hereinafter referred to as the CDE) within 15 days from the date of issuance of this Announcement, together with the supporting materials. Specific requirements shall be separately issued by the CDE. Failure to file the application within the prescribed time limit shall be deemed a waiver of the right to drug trial data protection. Where the remaining review time limit is less than 20 days, the CDE shall suspend the clock of the review time limit, which shall resume after a preliminary review opinion on drug trial data protection is finalized. Upon completion of the technical review, the CDE shall submit the preliminary review opinion together with the technical review results to the NMPA. Drugs verified to meet the conditions for drug trial data protection upon examination shall be handled in accordance with the relevant provisions of the Implementation Measures.

III. For drug registration applications that have already entered the administrative approval stage but have not yet been approved as of the date of this Announcement, and that meet the conditions for the grant of drug trial data protection as specified in the Implementation Measures, the applicant shall file an application for drug trial data protection with the CDE within 15 days from the date of issuance of this Announcement. From the date of this announcement until the CDE officially publishes the data protection information on its website, no drug registration applications relying on the aforesaid protected data shall be accepted or approved.

It is hereby announced.

Annex: Implementation Measures for the drug trial data protection

　　National Medical Products Administration

　　15th May 2026