The termination of Internet Explorer

We have written this year about EMA’s product information system for medicinal products, XEVMPD, and its lack of support of current day web browsers such as Chrome, Mozilla, Edge and Safari. The system can be only used with Internet Explorer (IE) which was by itself already annoying but became a real challenge for all European regulatory affairs professionals in July 2022 when Internet Explorer was terminated.

During the past summer EMA introduced IE Tab extension for modern browsers as a solution. Users of XEVMPD are able to acquire a license for IE Tab from the EudraVigilance page and the software license is paid by EMA. The extension emulates old versions of Internet Explorer software and according to the developer of the extension it can be used for Java, Silverlight and ActiveX.

When will Chrome or other browsers be supported?

Some time ago, we received a question from a reader of the Tepsivo blog asking when modern browsers would be supported by XEVMPD. As EMA had not communicated anything related to timelines or details about this particular matter we did not have any idea of when that could be. To find out more, we contacted the EMA through the official communication pathway.

To give some background information, it turned out that our reader was in a situation where Internet Explorer was no longer available but installing an extension to a browser was not that simple. Many life science organizations and corporations in general restrict what their users can install on their computers and there are organizations that even restrict what sites the users can access through their browser using the company network. Executable files and browser extensions are known safety risks, so it is understandable. Life science and healthcare organizations tend to be particularly careful with staff of varying IT skills handling sensitive information.

In the current situation with XEVMPD, the IT departments of pharmaceutical companies and other healthcare organizations have to customize or configure user setups for the regulatory team members who are responsible for updating or monitoring medicinal product information in the XEVMPD.

There will be no update

The response we received from the EMA was the following:

“The XEVMPD/Article57 user interface (EVWEB) can only be accessed using an IE Tab extension in Google Chrome or Microsoft Edge.
There are no plans to change the platform as XEVMPD submissions will be replaced with PMS submissions in the future. PMS UI will be built taking into account those limitations and using current browsers.”

This answers the question partially: XEVMPD will never be updated to support Chrome, Safari or Mozilla but there will be a time when the regulatory affairs experts submitting marketing authorization applications, updating the product information or contact details related to the organization responsible for the products will be able to perform these tasks no matter what browser they are using. But we do not know when that time will be.

EMA has not published any updates since July 2022 related to the implementation of Product Data Management Services (PMS). As we have described in our comprehensive description of IDMP, the first iteration of the PMS is planned to cover a subset of the authorized medicinal product part of the ISO IDMP standards and the new ISO IDMP compatible data submission format (HL7 FHIR) replaces the current data submission format, the eXtended EudraVigilance Product Report Message (XEVPRM).

In 2022, EMA has focused on replacing the current .pdf based electronic application and variation forms (eAF) by web-based forms as part of DADI project and improving the technical components needed to reflect authorized data in the PMS. PMS is linked to the electronic variation forms because it provides the product data for these.

Importantly for the timeline of delivering a new product information management system and finally ending the era of playing around with Internet Explorer emulations, EMA is still deciding on some aspects of the PMS implementation.

• “whether it is still relevant to follow a two-step approach (CAP & Fast Healthcare Interoperability Resources (FHIR) message first; non-CAPs second) and how this impacts the process described in the EU Implementation Guide’s (EU IG) chapter 3;


• whether replacing the Art 57 data submission format, the eXtended EudraVigilance Product Report Message (XEVPRM) format, with the new ISO IDMP compatible format (HL7 FHIR) takes place only after all relevant application forms are released by the Digital Application Dataset Integration (DADI) project.”

Especially the latter seems to be relevant for the timeline. DADI variation forms project timeline is by the end of Q4 2023. If EMA decides to wait until the end of the DADI forms, which now have a new name (and abbreviation, of course): Product Lifecycle Management (PLM) Portal, it means that at least one part of PMS implementation would start earliest in 2024.