Guidelines

Date
2023-08-06
Drugs Guide
Child resistant packaging requirements
2023-07-09
Drugs Guide
Clinical Considerations for Efficacy and Safety Assessment
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)
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