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Center for Drug Evaluation issued the Technical Guidance for Real-World Study Supporting Research & Development and Evaluation of Pediatric Drugs (Interim)

CCFDIE| Updated: 2020-09-01

Considering the actual needs in research & development and registration of pediatric drugs, to help enterprises better understand the application of the Guidance for Real World Evidences Supporting Research & Development and Evaluation of Drugs (Interim) in research & development of pediatric drugs, upon the approval by the NMPA, CDE issued the Technical Guidance for Real-World Study Supporting Research & Development and Evaluation of Pediatric Drugs (Interim) on August 27, 2020, which shall come into force as of the date of issuance.