AEMS guidance for sponsors

This user guide outlines how sponsors can access and use the Adverse Event Management System (AEMS) web portal. It is designed to reduce administrative burden and provide sponsors with additional reporting and search functions to assist in fulfilling their pharmacovigilance responsibilities.

Find out how to:

• access the AEMS portal
• report adverse event using the reporting form
• search for adverse events in the AEMS portal
• generate, view, and download adverse event reports as public case details (PCD) or a case line listing (CLL)
• access historical reports submitted via the Adverse Drug Reaction System (ADRS).

In line with the Therapeutic Goods Administration (TGA) guidance Pharmacovigilance responsibilities of medicine sponsors, sponsors should refer to the public Database of Adverse Event Notifications (DAEN) as the source of truth for individual adverse events reported to the TGA for their products.   

Where additional data is not available through the AEMS web portal for a case of interest, please email us for this information at adr.reports@health.gov.au.

Download the user guide