Global Adverse Event Databases

The United States Food and Drug Administration

Mandatory Reporting According to Applicable Regulations

Drugs and Biologics

  • Drugs – FDA Adverse Event Reporting System (FAERS) Data Files

Devices

Vaccine Adverse Event Reporting System

Australia – Therapeutic Goods Administration

Database of Adverse Event Notifications (DAEN)

The Therapeutic Goods Administration (TGA) receives adverse event reports associated with medicines and medical devices. These reports come from a wide range of sources, including members of the public, general practitioners, nurses, other health professionals and the therapeutic goods industry.

The Database of Adverse Event Notifications – medicines contains information from reports of adverse events that the TGA has received in relation to medicines, including vaccines, used in Australia.

  • Medicines – Database of Adverse Event Notifications (DAEN for Medicines)
  • Medical Devices – Database of Adverse Event Notifications (DAEN for Medical Devices)

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Canada

The Canada Vigilance Program is a spontaneous reporting system that is designed to detect signals of potential health product safety issues during the post-market period.

EU

European Database of Suspected Adverse Drug Reaction Reports

You can view data on suspected side-effects also known as suspected adverse drug reactions for authorised medicines in the European Economic Area (EEA).

EUDAMED: European Database on Medical Devices – a secure web-based portal acting as a central repository for information exchange between national competent Authorities and the Commission.

Japan

The Japan Council for Quality Health Care (JQ) has been conducting various activities, such as the Project to Collect Medical Near-Miss/Adverse Event Information and the evaluation of medical services provided at hospitals, in order to maintain public confidence in healthcare services and improve the quality of the services.

Germany

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent federal higher authority within the portfolio of the Federal Ministry of Health.

Korea – The Korea Institute of Drug Safety and Risk Management (KIDS)

  • The Korea Adverse Event Reporting System (KAERS)

UK

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Last Updated: 2016-06-03

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