General Administration Department of the National Medical Products Administration, Implementing Measures for the Protection of Pharmaceutical Trial Data (Trial Implementation, Draft for Comments)

国家药监局综合司药品试验数据保护实施办法 (试行，征求意见稿)

China proposes different data protection periods for three categories of drugs / Issued: 2025-03-19

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Issued: March 19, 2025

Main contents: A six year data protection term shall be granted from the date of the first domestic1 marketing authorization for an innovator drug.