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General Administration Department of the National Medical Products Administration, Working Procedures for the Protection of Pharmaceutical Trial Data (Draft for Comments)
国家药监局综合司药品试验数据保护工作程序 (征求意见稿)
NMPA details procedures for applying for pharma data protection / Issued: 2025-03-19
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Issued: March 19, 2025
Main contents: The Center for Drug Evaluation (the “DEC”) of the National Medical Products Administration (the “NMPA”) is responsible for specifically carrying out the data protection work under the guidance of the NMPA.
When accepting an application for marketing authorization for a chemical drug or biologic, the data protection application submitted by the pharmaceutical registration applicant (the “Applicant”)