TGA Move to Improve Access to Device Information

The TGA have implemented two new website functions to provide better access to device information. Details are below.

• Adverse Event Database (DAEN)

In a response to the need for more information about device adverse events to be publicly available, the TGA have launched an adverse event database called DAEN – database of adverse event notifications.

The database provides public information regarding adverse events and near adverse events occurring in Australia. It includes only events captured using the online reporting system starting in June 2012 and includes reports from a wide range of sources, such as members of the public, general practitioners, nurses, other health professionals and the therapeutic goods industry.

• Australian Register for Therapeutic Goods (ARTG) Access

The ARTG can now be searched via the TGA website (www.tga.gov.au) in addition to the online system eBusiness website (www.ebs.tga.gov.au).  The search function will now produce results relating to information and resources, in addition to specific ARTG inclusions.

For further information about expected TGA reforms, contact KD&A.