To promote the innovative development of pharmaceuticals and improve the protection system for pharmaceutical test data, the National Medical Products Administration (NMPA) has formulated the "Measures for the Protection of Pharmaceutical Test Data" (hereinafter referred to as the "Measures") with reference to relevant laws such as the "Drug Administration Law of the People's Republic of China" and its implementing regulations, and international experience. The Measures are hereby promulgated and shall come into effect from the date of this announcement. Relevant matters are announced as follows:
1. From the date of this announcement, applicants for drug registration may submit an application for the protection of pharmaceutical test data simultaneously with the submission of a drug registration application.
2. For drug registration applications that have been accepted before the date of this announcement but have not yet completed the review, if they meet the conditions for protection of pharmaceutical test data as provided in the Measures, the applicant shall submit an application for the protection of pharmaceutical test data to the Center for Drug Evaluation of the NMPA (hereinafter referred to as the CDE) within 15 days from the date of this announcement and provide relevant materials. Specific requirements will be separately issued by the CDE. Failure to submit within the prescribed period shall be deemed a waiver of the protection of pharmaceutical test data. If the review period is less than 20 days, the CDE shall suspend the countdown and resume it after forming the preliminary opinion on the protection of pharmaceutical test data. After completing the technical review, the CDE shall report the preliminary opinions to the NMPA. Drugs that are reviewed and determined to meet the conditions for data protection will be implemented in accordance with the relevant provisions of the Measures.
3. For drug registration applications that have entered the administrative approval stage before the date of this announcement but have not yet been approved, if they meet the conditions for protection of pharmaceutical test data as provided in the Measures, the applicant shall apply to the CDE for protection of pharmaceutical test data within 15 days from the date of this announcement. From the date of this announcement until the data protection information is publicly announced on the CDE website, drug registration applications relying on the protected data will neither be accepted nor approved.
Attachment：
Measures for the Protection of Drug Trial Data.doc
National Medical Products Administration May 15, 2026
(Reprinted from: Official WeChat account of the Drug Evaluation Center of the National Medical Products Administration)