Adverse event monitoring internationally

The TGA, like other regulatory agencies around the world, monitors the safety of medicines, vaccines, medical devices and biologicals to contribute to a better understanding of their possible adverse effects when they are used in the market place. This is known as 'therapeutic product vigilance'.

World Health Organization

The World Health Organization (WHO) Programme for International Drug Monitoring is an international collaboration being maintained by the Uppsala Monitoring Centre, Sweden. As of December 2014, 120 countries had joined the collaboration, including Australia.

VigiBase is the WHO database of adverse event reports. The TGA sends reports to VigiBase, and often uses VigiBase data in its investigation of potential safety signals associated with medicines supplied in Australia.

The WHO Department of Essential Health Technologies (EHT), Diagnostics Imaging and Medical devices Team (DIM) aims to ensure improved access to, quality and use of safe and appropriate medical devices in line with Primary Health Care Reform.

New Zealand

As New Zealand is one of our near neighbours, the TGA works closely with its therapeutic goods regulatory agency, the Medicines and Medical Devices Safety Authority (Medsafe). Information on important safety signals is routinely shared and the TGA regularly collaborates with Medsafe on a range of other issues.

In New Zealand the collection of adverse events related to medicines is contracted by the Ministry of Health to the New Zealand Pharmacovigilance Centre (NZPhvC). The Centre for Adverse Reactions Monitoring is part of the NZPhvC and collects and evaluates spontaneous reports of adverse events related to medicines, vaccines, herbal products and dietary supplements from New Zealand health professionals and consumers. The centre informs Medsafe about possible safety signals associated with medicines.

The collection and evaluation of adverse events related to medical devices for possible safety issues is undertaken by Medsafe.

International adverse event databases

Worldwide, a number of regulatory agencies make information about reported adverse events publicly available. These include:

Medical devices

• the US Food and Drug Administration Manufacturer and User Facility Device Experience.

Medicines

• the Danish Health and Medicines Authority Interactive Adverse Drug Reaction overviews
• the European Medicines Agency Suspected Adverse Drug Reaction Reports Database
• the Health Canada Canada Vigilance Adverse Reaction Online Database
• the Netherlands Pharmacovigilance Centre Lareb Databank
• the New Zealand Medsafe Suspected Medicine Adverse Reaction Search
• the UK Medicines and Healthcare products Regulatory Agency Interactive Drug Analysis Profiles
• the US Food and Drug Administration FDA Adverse Event Reporting System (FAERS).