Guidelines

Date
2023-04-04
Drugs Guide
Guidance on Submission of Chemistry, Manufacturing, and Control (CMC) Information for Cell-based Clinical Trial Applications
2023-03-29
Drugs Guide
Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances (VICH GL39)
2023-03-22
Medical Devices Guide
Guidance on MDMA –Significant and Non-Significant Changes (MDS-G012)
2023-01-30
Drugs Guide
Guideline on good pharmacovigilance practices (GVP)
2023-01-05
Drugs Guide
Good Manufacturing Practice (GMP) Guidelines
2023-01-03
Medical Devices Guide
Guidance for Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices (MDS – G010)
2022-12-22
Medical Devices Guide
Guidance for the operation and use of radiation emitting medical devices (MDS – G007)
2022-11-28
Drugs Guide
Approach of Dealing with Patents When Register Generic Drugs in SFDA
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