Improving access to medicine adverse event data – sponsor survey

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.

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.

New AEMS adverse event search for sponsors

On 20 November 2023, we launched new functionality allowing sponsors to search for and download de-identified adverse event reports relevant to their medicines and biologicals. This means sponsors no longer need to email the TGA to request this information.

Sponsors can now log into the AEMS portal using their AEMS/TGA Business Services (TBS) accounts and view, search, filter and extract data on adverse event reports submitted since 2018, including those:

• submitted by parties other than the sponsor organisation
• containing the same active ingredient as their products but where the tradename was not specified
• with a decision of rejected or withdrawn.

Through this new functionality sponsors have greater and faster access to adverse event data to support their pharmacovigilance obligations and analysis of safety signals.

Guidance on using this new functionality is available in the AEMS guidance for sponsors.

Other improvements to how we share adverse event data

In June 2021, we implemented improvements to the DAEN – medicines, including how information is displayed on‑screen and the ability to download public data in multiple formats.

We are considering other improvements to how we receive and share medicine adverse event data in the future, including the voluntary adoption of the ICH E2B(R3) standard.