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
Issued: March 19, 2025
Main contents: A six year data protection term shall be granted from the date of the first domestic marketing authorization for an innovator drug.
Where an application is made for the marketing in mainland China of an originator drug that is marketed abroad but not yet marketed in mainland China, the data protection term shall be six years minus the time difference between date of acceptance of the application submitted for marketing authorization for the drug in mainland China and the date on which marketing authorization was first secured outside of mainland China for such drug.
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