Medical Product Safety and Pharmacovigilance Subject Guide

Official web site for the Council for International Organizations of Medical Sciences (CIOMS)

A set of measures drawn up to facilitate the performance of the safety monitoring of medicines in the European Union

Web site for the European Medicines Agency (EMA) including detailed operational requirements of all EMA pharmacovigilance tasks including links to EU legislation

The Daily Journal of the United States Government

All efficacy guidelines developed by ICH including those specific to pharmacovigilance (E2A-E2F)

Official web site for the Medical Dictionary for Regulatory Activities (MedDRA)

Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

This website provides summary information about ongoing and completed postmarket safety evaluations of adverse experience reports made to FDA

Description of FDA’s postmarketing surveillance programs including FDA Adverse Event Reporting System (FAERS)

Excellent source of web sites for over 80 regulatory authorities throughout the world

VAERS is a post-marketing safety surveillance program, collecting information about adverse events (possible side effects) that occur after the administration of vaccines licensed for use in the United States.