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XEVMPD Windows and browser support
Recent notifications and document updates by EMA
Martti Ahtola | Nov 4, 2021
We recently wrote in our blog about the browser support issues that EMA is having with their XEVMPD / Article 57 database that is mandatory to be used by all pharmaceutical companies who have authorized products or ongoing trial in the EU. We were not the only ones who have been wondering about this and now it seems that EMA is finally doing something about it.
New guidance coming
EMA communicated today to the EudraVigilance users that there is a new ‘xEVMPD Support’ section available under ‘User Support’ in the EudraVigilance Restricted area.
According to EMA, they strongly recommend “using the latest version of Windows and supported web browsers to access the latest security updates, in line with best practice. EMA will provide further guidance on supported browsers in early 2022.”
EMA has also uploaded a new version of Article 57 User Interface (UI) Installation Guide. For us personally, the highlight of this updated guide is the following sentence:
“This will be done in Internet Explorer or an Internet Browser which can emulate Internet Explorer and will be further described in the next steps.”
What is not mentioned on the publicly available EMA page, is the following information:
“EVWEB may require, depending on the software available on the Windows Client, to install an ActiveX Component for the User Interface […]. For versions of IE 8 and above, users also need to set their IE browser to compatibility view. New Windows 10 versions (20H1 and onwards) are not compatible with the version of ActiveX currently in use. Users are therefore advised to follow the below instructions to install Art57 UI on Microsoft Windows 10 20H1 and onwards versions.”
“These instructions have been developed in collaboration with Microsoft Support. Updating to the latest version of Microsoft Windows 10, and following these instructions, will improve the security profile of your workstation.”
“Following Microsoft’s announcement that IE11 will be retired from 15 June 2022 (see here) EMA has been testing Art57 UI using Edge and will communicate in Q1 2022 its recommendations and guidance. EMA is planning to upgrade Art57 UI using modern technologies and align it with its SPOR roadmap, which will be shared with stakeholders in 2022.”
Conclusion
Based on this limited information, it seems that EMA is working hard to move from the outdated systems to this century. It remains to be seen if they will succeed providing XEVMPD support for other browsers than IE and Edge before it becomes impossible to run the system in a secure way. For us EVWEB – Art 57 / XEVMPD was still working today without any changes or new downloads and installations.
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Hi,
Do you know if XEVMPD / Article 57 should work on Windows 11?
We have tried with Microsoft Edge in IE mode but we get an ActiveX error. We have made the same settings as we have done on Windows10 but we can’t make it work on Windows 11.
Thank you in advance,
Kind regards,
Martin
@Martin yes works with WIN 11, but you need use the IE tab extension as instructed by EMA.
@Martti Thank you for your answer. The EMA support has told me that they are working on a browser-based solution for a new XEVMPD UI that doesn’t need ActiveX or IE tab extension.