Guidelines

2023-06-04
Drugs Guide
Guidance for Orphan Drug Designation
2023-06-01
Drugs Guide
Guideline on the Braille Requirements for Labeling Information of Medicinal Products for Human Use
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)
2023-03-22
Medical Devices Guide
Guidance on Manufacturing Paths of Medical Devices and Supplies (MDS-G011)
2023-03-20
Food, Drugs, Medical Devices Guide
Regulations and Requirements for the clearance of medicines, pharmaceutical products, medical devices, and food products that arrive for pilgrims use
2023-02-06
Medical Devices Guide
(MDS – G009) Guidance for Points of Care (POC) Medical Devices Manufacturing
2023-01-30
Drugs Guide
Guideline on good pharmacovigilance practices (GVP)
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