Useful Links

Regulatory

Europe

• European Medicines Agency
• European Good Pharmacovigilance Practices Guidelines
• MHRA
• UK SmPC

USA

• FDA Drug Safety guidances
• MedWatch
• USPI
• REMS

Japan

• MHLW
• PMDA

Other Regions

• Arab Guidelines
• Russian Guidelines
• Israel Pharmacovigilance Section
• Arab PV guidelines Rename to Saudi Guideline on Good PV Practice

EU Record Linkage Databases

• PHARMO
• Clinical Practice Research Datalink
• EPID Research

WHO

• Uppsala monitoring centre

Pharmacoepidemiology and PASS

• ISPE
• GPP
• ENCePP
• GVP VIII
• Sentinel Initiative

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