News23.09.2025

The latest drug safety regulatory updates you need to know

πŸ“’ No spin. Just the latest #drugsafety regulatory updates you need to know.

πŸ‡¨πŸ‡¦ Canada: Guidance document updates for Good Pharmacovigilance Practices (GVP) inspections - Public consultation

πŸ‡¨πŸ‡Ώ Czechia: Publication of Summaries of Risk Management Plans - New

πŸ‡°πŸ‡ͺ Kenya: Guidelines on Submission of Documentation for Compassionate Use Authorization (CUA) of Health Products and Technologies – New

πŸ‡ΈπŸ‡¦ Saudi Arabia: GVP Product- or Population-Specific Considerations III: Advanced Therapy Medicinal Products – Public Consultation

πŸ‡ΊπŸ‡Έ USA: Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act - Draft guidance

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#pharmacovigilance #patientsafety