Guidelines

Date
2025-06-18
Drugs Guide
Guideline on Quality Considerations for Development and Comparability Assessment of Biosimilars
2025-05-12
Drugs Guide
Regulatory Guidance for Literature Based Support for Efficacy and Safety of Medicine
2025-05-04
Drugs Guide
Classifying Legal Status of Veterinary Medicinal Products Guidance
2025-03-25
Drugs Guide
Guidelines for Variation Requirements
2025-03-25
Medical Devices Guide
Guidance for ISO 13485 Requirements and Corresponding SFDA-MDS Requirements (MDS-G024)
2025-02-02
Drugs Guide
Regulation and Requirements for Conducting Clinical Trials on Drug
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