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Consultation: Improving access to medicine adverse event data - sponsor survey

19 January 2022

Opening date: 19 January 2022

Closing date: 18 February 2022

We have changed the way to make submissions.

Submissions now should be provided through our consultation hub.

This consultation closed on 18 February 2022.

The Therapeutic Goods Administration (TGA) sought feedback from sponsors on a proposal to improve their access to medicine adverse event data to support their pharmacovigilance obligations.

There is currently no ability for sponsors to automatically view or export de-identified adverse event data held in TGA systems. Instead, sponsors seek to access relevant data by manually searching the public Database of Adverse Event Notifications (DAEN) - Medicines and through email requests to the TGA. Both of these methods are inefficient for sponsors and the TGA, resulting in delays in access to important safety information.

We propose to implement functionality that allows sponsors to view and export relevant de-identified medicine adverse event data from TGA systems using their existing sponsor authentication processes. To develop this functionality, we are seeking feedback on:

  • What medicine adverse event data do sponsors wish to view and/or extract from TGA's Adverse Events Management System.
  • The preferred format(s) for the extracted data to support its upload into sponsor pharmacovigilance systems.
  • Sponsors' ability to transition to use the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Enterprise to Business (E2B) R3 standard for submitting and receiving adverse event reports via the secure Electronic Data Interchange service.

For more information and to have your say, please view and complete the online survey on the TGA Consultation Hub.

Timetable

The survey opened on Wednesday 19 January 2022. Interested parties responded by close of business Friday 18 February 2022.

Enquiries

For enquiries relating to the consultation or your submission please email medsafetyprojects@health.gov.au.