Australia’s TGA Launches Database of Adverse Event Notifications

Posted 19 June 2013 By Ansis Helmanis, RegLink

Australia's Therapeutic Goods Administration has launched a new Database of Adverse Event Notifications (DAEN), an online resource that will provide the public and the health care community with access to adverse event reports.

The database, which will be updated monthly, includes reports from January 1971 up until three months prior to the date of access to allow the agency to investigate new reports.   The database currently contains around 251,000 reports of adverse events, divided into two parts, one for those relating to drugs and vaccines, and the other for those relating to medical devices. 


TGA: DAEN Reporting

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Categories: Regulatory Update, TGA

Tags: DAEN, Adverse Event Reporting, australia

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