This page provides direct links to important official pharmacovigilance, drug safety, and regulatory guidance resources. Always verify current requirements from the official authority website before making regulatory or compliance decisions.
Global Pharmacovigilance and Drug Safety Resources
- US FDA Drug Safety and Surveillance
- US FDA FAERS – Adverse Event Reporting System
- EMA Good Pharmacovigilance Practices – GVP
- EMA Pharmacovigilance – Post Authorisation
- MHRA Good Pharmacovigilance Practice
- WHO Pharmacovigilance
- WHO Uppsala Monitoring Centre – UMC
- ICH Efficacy Guidelines – E2 Pharmacovigilance Series
- MedDRA Official Website
- CIOMS – Council for International Organizations of Medical Sciences
Country and Regional Regulatory Authorities
- Health Canada – MedEffect Canada
- Therapeutic Goods Administration – TGA Safety Information
- PMDA Japan – Safety Information
- CDSCO India – Pharmacovigilance
- Pharmacovigilance Programme of India – PvPI
Important Note
These links are provided for educational reference only. Regulatory requirements may change over time. Readers should always consult official authority websites, applicable local regulations, company SOPs, and qualified regulatory professionals before making pharmacovigilance compliance decisions.