Joint Adverse Event Notifications System (JAENS)

The Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) receive 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 products industry. There are two search facilities below:

JAENS – medicines provides information about adverse events related to medicines and vaccines used in Australia and New Zealand
JAENS – medical devices provides information about adverse events related to medical devices used in Australia and New Zealand
JAENS – medicines
photo of tabletsThe JAENS – medicines contains information from reports of adverse events that the TGA and Medsafe has received in relation to medicines, including vaccines, used in Australia and New Zealand.

Search JAENS – medicines

More information about the JAENS – medicines
JAENS – medicines: consumer questions and answers
Consumer questions and answers about the JAENS – medicines
About the JAENS – medicines
Limitations of the data and search results
Instructions for searching the JAENS – medicines
How to use the JAENS – medicines
JAENS – medicines: about the search results
Information about the two types of search results from the JAENS – medicines
TGA safety monitoring of medicines
The TGA, like other regulatory agencies around the world, monitors the safety of medicines, including vaccines, to contribute to a better understanding of their possible adverse effects when they are used outside the controlled conditions of clinical trials
Medsafe safety monitoring of medicines
Medsafe, like other regulatory agencies around the world, monitors the safety of medicines, including vaccines, to contribute to a better understanding of their possible adverse effects when they are used outside the controlled conditions of clinical trials
Overview of how TGA manages adverse event reports
The information in the internal TGA database is analysed by the TGA for patterns of adverse events that may indicate a safety issue
Overview of how CARM manages adverse event reports
The Ministry of Health in New Zealand contracts the collection of adverse events related to medicines to the Centre for Adverse Reactions Monitoring (CARM) part of the New Zealand Pharmacovigilance Centre (NZPhvC). CARM provides Medsafe with data on potential safety issues
Medical Dictionary for Regulatory Activities – MedDRA
The Medical Dictionary for Regulatory Activities (MedDRA) is an internationally used set of terms relating to medical conditions, medicines and medical devices
Adverse event monitoring internationally
Worldwide, a number of regulatory agencies make information about reported adverse events publically available
JAENS – medical devices
photo of medical devicesThe JAENS – medical devices contains information from reports of adverse events that the TGA and Medsafe have received in relation to medical devices used in Australia and New Zealand.

Search JAENS – medical devices

More information about the JAENS – medical devices
JAENS – medical devices: Consumer questions and answers
Consumer questions and answers about the JAENS – medical devices
About the JAENS – medical devices
Limitations of the data and search results
Instructions for searching the JAENS – medical devices
How to use the JAENS – medical devices
JAENS – medical devices: about the search results
Information about the two types of search results from the JAENS – medical devices
TGA safety monitoring of medical devices
How the TGA monitors medical devices and detects potential safety concerns
Medsafe safety monitoring of medical devices
How Medsafe monitors medical devices and detects potential safety concerns
Overview of how TGA manages medical device adverse event reports
The information in the internal TGA database is analysed by the TGA for patterns of adverse events that may indicate a safety issue
Overview of how Medsafe manages medical device adverse event reports
The information in the internal Medsafe database is analysed by Medsafe for patterns of adverse events that may indicate a safety issue
Global Medical Device Nomenclature – GMDN
Information on the Global Medical Device Nomenclature (GMDN) system
Adverse event monitoring internationally
Worldwide, a number of regulatory agencies make information about reported adverse events publically available
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Content last updated: 27 June 2013

Content last reviewed: 27 June 2013

Web page last updated: 27 June 2013

URL: http://www.anztpa.org/projects/aem.htm

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