The TGA is seeking feedback from sponsors, via an online survey, on a proposal to improve sponsor access to extract de-identified medicine adverse event data to support their pharmacovigilance (PV) obligations. Your feedback to the survey will help inform the TGA how to best tailor what data sponsors would like to view or extract.
The Sponsor survey is open now, closing on 18 February 2022.
This survey is part of the TGA’s Medicines Adverse Event Data Exchange project, which seeks to improve the management of medicines safety signals by:
- improving how TGA share medicine adverse event data held in TGA systems with sponsors, jurisdictions and the public; and
- making it easier for health professionals to report adverse events to the TGA.
About the Survey
There is currently no ability for sponsors to automatically view or export de-identified adverse event data held in TGA systems, which is needed as part of sponsor PV responsibilities. Instead, currently sponsors seek data by manually searching the public DAEN, and via email requests to the TGA, which is inefficient and causes delays.
This consultation proposes to implement new functionality that allows sponsors to view and export documents with relevant de-identified medicine adverse event data from TGA systems using existing sponsor authentication. They are seeking sponsors’ feedback on:
- What medicine adverse event data 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 OV 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.
Start the survey here and view the consultation page here.
Some of the survey questions require some thought and team discussion - information and survey questions can be accessed prior to starting the survey at this consultation document.
CMA would like to hear from members on how you perceive these proposals will help or hinder the complementary medicine industry and any concerns or constructive suggestions relating to the industry level. please contact Lucy.Lang@cmaustralia.org.auLucy.Lang@cmasutralia.org.au with feedback.