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SFDA issues Criteria for Writing Drug Periodic Safety Update Reports
- Publisher：
- Publication：2012/9/17
In order to standardize and offer guidance to the writing of drug Periodic Safety Update Reports (PSUR), improve drug manufacturers’ ability to analyze and evaluate drug safety issues, the State Food and Drug Administration (SFDA) formulated the Criteria for Writing Drug Periodic Safety Update Reports in accordance with the Provisions for Adverse Drug Reaction Reporting and Monitoring. The Criteria, which was issued recently, specifies the general requirements, basic principles and main contents for writing Periodic Safety Update Reports.