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New medicine adverse event search for sponsors

Published

We have launched a new search functionality in the Adverse Event Management System (AEMS) web portal. 

As a sponsor, you can now access TGA-held adverse event reports relevant to your medicines and biologicals in a self-serve manner. You can:

  • search for reports
  • filter results using multiple data attributes
  • download de-identified Public Case Detail (PCD) and Case Line Listing (CLL) reports for inclusion into your own pharmacovigilance systems.

This new functionality was created in response to feedback to our 2022 sponsor survey on Improving access to medicine adverse event data.

Guidance on using this new functionality is available in the AEMS guidance for sponsors.

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