New Adverse Event Management System launched
In response to feedback to the TGA's 2022 sponsor survey on Improving access to medicine adverse event data, the TGA have now finalised their launch of a new search functionality, the Adverse Event Management System (AEMS).
Sponsors can now access TGA-held adverse event reports relevant to their own medicines to:
- 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.
Sponsors can use the feature through the AEMS portal or TGA’s Business Services Sign In using your TBS account.
As specified in the AEMS guidance for sponsors, once a new TBS user account is created, it can only be used to access AEMS the next day. See New medicine Adverse event search for sponsors.
Electronic notification form updates
Following the update to the Pharmacovigilance responsibilities of medicine sponsors: Australian recommendations and requirements guidance in August, the TGA have made the following improvements to the medicine safety issues electronic notification form in response to stakeholder feedback.
1. A secondary email address field - an email address provided in this field will also receive a copy of the submitted safety issue notification.
2. A preview page - this will allow the reporter to review the details of their safety issue notification as the final step prior to submission of the form.
TGA Webinar: Understanding changes to the Pharmacovigilance (PV_ Guidelines
The TGA held 2 webinars in August, outlining and explaining the changes contained in version 3.0, with the opportunity for Q&A. A third and final TGA webinar is now set for Thursday 14 December at 1:00pm AEDT and will be a further opportunity for Q&A on the changes to the PV guidelines. The TGA are inviting stakeholders to submit questions prior to the webinar, as these will be addressed first and questions may not be accepted live during the webinar. Register for the webinar and submit questions here.
Reminder - implementation period
The 6-month implementation period of the changes to the PV, during which adoption of the changes included in this update are strongly encouraged but not mandatory and will not be inspected against, will conclude on Wednesday 31 January 2024. During this time, the TGA expect significant safety issues (SSIs) to continue to be reported. The TGA has advised that changes to reporting requirements will not be enforced or inspected against until February 2024. All existing requirements in the PV Guidelines are excluded from this implementation period and will continue to be enforced.