Guidelines

Date
2026-04-20
Drugs Guide
Framework on the Use of Real-World Data (RWD) and Real-World Evidence (RWE) to Support Effectiveness and Safety for Marketing Authorization of Medicinal Products
2026-04-12
Drugs Guide
Guideline on good pharmacovigilance practices(GVP)Product- or Population-Specific Considerations III: Advanced Therapy Medicinal Products
2026-04-02
Drugs Guide
Research and Investigational Drugs (RAID) Designation
2026-03-31
Drugs Guide
Guidelines for Variation Requirements
2026-03-09
Drugs Guide
Guidelines for Chemical and Pharmaceutical Quality Documentation of Small Molecules Investigational Product in Clinical Trial
2026-02-02
Drugs Guide
Clinical Considerations for Vaccines
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