Improving access to medicine adverse event data – sponsor survey

Closed 18 Feb 2022

Opened 19 Jan 2022

Feedback updated 28 Mar 2022

We asked

We asked for feedback on proposed new functionality that would allow sponsors to view and export relevant de-identified medicine adverse event data from TGA systems, using their existing sponsor authentication process (e.g. TGA Business Systems login credentials). We specifically asked about:

  • The type of medicine adverse event data sponsors would wish to view and/or extract from TGA’s Adverse Events Management System (AEMS) and their preferred format.
  • Sponsors’ views on using 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 (EDI) service.

You said

We received 44 survey responses from sponsors and research organisations spanning prescription, non-prescription and complementary medicines, and medicinal cannabis products. Respondents broadly supported the initiative and provided valuable feedback on our proposals.

Sponsor access to medicine adverse event data

Almost all respondents stated they rely on the public Database of Adverse Event Notifications (DAEN)-medicines and direct email requests to TGA to obtain information on medicine adverse events. Most respondents import this data into their company pharmacovigilance systems to fulfill their TGA pharmacovigilance responsibilities and to supplement their international reporting obligations.

For the proposed new functionality respondents wished to access the same information they receive through their existing mechanisms. They also requested access to additional data, such as data to assist in identifying duplicates, information about the seriousness of an adverse event, concomitant use of medicine and medical conditions, and case type (e.g., post-market, Special Access Scheme (SAS) or under clinical trial).

Viewing/extracting adverse event data held within TGA systems

Most respondents supported the use of the proposed functionality to view adverse event data that relates to both their own products and other products which have the same active ingredient. A large majority stated that they wish to extract data directly into their pharmacovigilance systems. Although it is not mandatory for sponsors to seek historical adverse event cases, many requested access to the full range of available mapped sponsor-product data. Many respondents indicated that automating the ability to extract data would reduce regulatory burden for sponsors in meeting their pharmacovigilance responsibilities. The majority preferred receiving adverse events data via E2B R3 ICSR message, with a flat .CSV file being the second preferred option. Other file format options were pdf and xml.

Most respondents agreed that agents (i.e. nominated officers external to the company who have permission to undertake regulatory correspondence with TGA on behalf of the sponsor) should have the same access as sponsors to this data.  

EDI Gateway

The majority of respondents stated they currently submit cases through the EDI Gateway, with almost all eager to receive data through this functionality. Some respondents who have not yet implemented EDI functionality also showed interest in future adoption to reduce manual processes.

Where use of EDI was not adopted, respondents stated this was due to concerns over lack of expertise in required standards, perceived complexity of the functionality, resource constraints, low volume of reportable cases and need for consistent formats with global partners.

E2B R3 – Current behaviour and transition

Most respondents currently submit case reports to overseas regulators using the ICH E2B(R3) standard and almost all respondents supported a voluntary transition to use of this standard as an input channel. Where not supported, reasons included concerns over company size, need for resources, and complexities involved in adoption.

Most respondents were eager to adopt the updated standard within a year’s time, with the majority stating they could transition within 6 months. Most other respondents are willing to transition within 2 years, with a small proportion stating they would require 3-5 years for implementation.

Product terminology

WHO drug dictionary was the most commonly used terminology for coding product information in sponsors’ internal systems and cases submitted in the E2B R3 format. Some respondents stated they use extended EudraVigilance medicinal product dictionary (XEVMPD) and bespoke terminology.

Some respondents are already using ISO IDMP standards for submitting cases in the E2B R3 format, with a few also planning to adopt these in the near future.

We did

We are considering your feedback

Thank you to everyone who responded to the survey. The feedback received will inform IT requirements for the proposed functionality, as well as our privacy impact considerations. Guidance for sponsors about this new functionality will be published as part of implementation.

Other improvements to how we share adverse event data

We are currently working on restoring the ability for users to extract and save search results from the DAEN‑medicines, as well as other improvements to how information is displayed on‑screen. These improvements are expected to be available on the TGA website in the coming months.

Published responses

View submitted responses where consent has been given to publish the response.

Overview

The Therapeutic Goods Administration (TGA) monitors the safety of medicines (including vaccines) by collecting and assessing reports of adverse events and taking regulatory action to improve medicine safety. The sponsors of medicines in Australia also have pharmacovigilance responsibilities, including the need to collect and assess adverse event reports and inform the TGA where any significant safety issues have been identified for their products.

The Medicines Adverse Event Data Exchange project seeks to improve the management of medicines safety signals by:

  • improving how we 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.

This survey is specifically seeking feedback on improving access to adverse event data for medicine sponsor organisations to assist with their pharmacovigilance obligations.

Sponsor access to medicine adverse event data

Medicine sponsors need access to product related adverse event data to fulfill their pharmacovigilance responsibilities. 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 (AEMS).
  • 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 (EDI) service.

We want your feedback

We invite you to provide your feedback by completing our online survey.

All survey responses will be published on the TGA Consultation Hub, unless requested to be kept confidential.

Please contact us at medsafetyprojects@health.gov.au if you have any issues with completing this survey.

What happens next

This consultation has now closed. Thank you to all who provided their feedback.

We will be reviewing and analysing all feedback received and updating the results on this page. Watch this space!

Audiences

  • Prescription medicines
  • Complementary medicines
  • Over-the-counter medicines
  • Biologicals
  • Other

Interests

  • e-Health
  • Regulatory policy
  • Immunisation
  • Prescription drugs
  • Non-prescription medicines