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28 2025.04
Guidance on the Application of Real-World Data Based on Disease Registries (Final)
20 2023.03
Guidance on the Design and Protocol Development of Real-World Studies for Drugs (Final)
17 2023.03
Guideline on Using Patient Reported Outcomes in Drug Clinical trail (Final)
17 2023.03
Guidance on Communications of Using Real-World Evidence to Support Registration Applications for Drug and Biological Products (Final)
17 2023.03
Guideline on Using Real-World Study to Support the Development and Evaluation of Pediatric Drugs (Final)
17 2023.03
Guideline on Clinical Development of New Drug of Traditional Chinese Medicine Compound Preparations Based on Human-use Experience (Final)
03 2022.08
Statistical Guidelines on Clinical Studies of Drugs for Rare Diseases (Final)
01 2022.04
Guidance on Using Real-World Evidence to Support Drug Development and Regulatory Evaluation （Final）
01 2022.04
Guideline on Using Real-World Data to Generate Real-World Evidence (Final)
26 2022.01
Guideline on Integrated Summary of Efficacy for Clinical Trials (Final)