On Monday 16th May, the European Medicines Agency (EMA) hosted their latest webinar on the implementation of the new eAF (electronic Application Form) Portal, or, the “DADI” project, entitled “DADI-PMS Webinar: Variations Form for Human Medicinal Products - What will happen at Go-Live”. This webinar took a slightly different angle to the others we’ve seen to date which have focussed on: the data structure of the new eAF, overlaps with XEVMPD and IDMP, and the look and feel of the as yet unnamed new system.
Now, EMA wants to talk about process, which is important and welcome news. Clarity around the new process is needed; from a documentation perspective we are less informed today than we were at the turn of the year, with EMA withdrawing chapter three of the implementation guide, and potentially moving away from the two-step implementation approach. Why bring this up now? While webinars are a great way to share information, as the implementation of the new web form gets ever closer, the need for clear, written, detailed information is becoming increasingly more urgent.
This blog is a summary of my opinions, based on my understanding of EMA’s webinar and the material provided on the accompanying slides. If there’s anything which you interpreted differently, or if you’re able to provide a bit more colour to this, then please leave your comments below.
Firstly, the User Acceptance Testing (UAT) phase of the project has been extended. The Limited UAT which was due to complete in Q2 2022 will spill over into Q3. The wider UAT will now run into Q4 2022, leaving less time between completion of the UAT and launch of the form, which remains planned for Q4 2022.
The Data Cleansing phase has been removed entirely from the plan. This had been scheduled to start in Q1 2023 and complete in Q4 of the same year. The removal of the data cleansing phase is explained as: “correcting/completing product data…is not required for the successful use of the DADI variations forms…”. The new plan includes intermediate releases in Q2 and Q3 of 2023, and a major release in Q4 to manage changes to structured data fields (following a brief UAT in Q3 to test this functionality) – I’ll cover this in a little more detail further on.
Other significant points to note
1. XEVMPD Changes?
It was reiterated that XEVMPD submissions will be required at the go-live of the new eAF portal, something we already knew. The really interesting part of the update is contained in the following slide:
“In the future electronic Application Forms (eAFs) can be used to update Art 57.”
The Article 57 process has been around in, basically, the same form for a decade; the update process is stable (if inefficient); and organisations, systems and procedures probably haven’t changed a great deal over the last few years.
Changing the Article 57 process now seems, to me, a strange idea. IDMP timelines are already difficult, resource is clearly at a premium, and as I see it; any diversion away from implementing the Target Operating Model (TOM) in the PMS is likely an unwanted distraction for all involved. Hopefully more clarification will come soon.
1. Management of Structured Data
In the webinar, EMA provided a little more detail on how structured data will be managed in the new eAF, and its plan for managing changes to these data.
The EMA plans to utilise structured PMS data in the new eAF, which will be migrated from SIAMED (CAPs only) and the Article 57 (XEVMPD) database. It has clarified the scope of the data which will be used from the PMS in the new portal at go-live, which is much more limited than the scope provided in the FHIR mapping spreadsheet, and of course the EU IDMP Implementation Guide.
The definition of the word “used” above is clear: data which has been migrated to the PMS from XEVPMD and SIAMED will be made available to view in the eAF portal and used for the purpose of completing the form. It does not mean that the MAH will be able to make changes or corrections to this data in the PMS using the eAF directly. If the structured data elements in question are migrated from XEVMPD, it will be possible to change or correct them in the PMS by updating XEVMPD itself. This updated data will then be made available to use in the new eAF in “near real-time” (though, I’m not sure if this is from the submission of the XEVMPD update by the MAH, or from the EMA final acknowledgement – an important distinction). If, however, the structured data elements are not available in XEVMPD, they cannot be updated in the PMS, and so MAHs may see incorrect or inconsistent information every time they intend to submit an impacting variation (i.e., one which intends to change the structured data elements).
As I mentioned earlier, EMA plans to introduce the ability to make changes to structured PMS data fields using the eAF in their next major release, coming in Q4 2023. The data cleansing window has been removed from the implementation plan entirely. This means that it will not be possible to update or correct any PMS data using the eAF directly, until at least Q4 2023, and this phase will cover only a very limited set of data. As a consequence, some data may remain incorrect or inconsistent in the PMS for potentially 16 months or more. This is sure to frustrate and confuse many.
I’m frequently asked about our plans for helping our customers to manage DADI, and while many companies are currently working through their data, finding the gaps, managing the transformations, adjusting to the required granularity; this update from the EMA concerns me, because:
The structured data used in the new eAF portal will potentially deviate to some extent from the IDMP standards, so your IDMP compliant RIM data may not match the information presented to you in the new eAF portal.
The period of time that these differences will exist is likely to be a lot longer than first anticipated.
The opportunity to fix these things looks to be very limited – at least in the first instance .
EMA has stated that one of the goals of the PMS is to deliver a trusted, good quality source of product data. This is important, and I think the EMA needs to consider whether its current plans allow this to a sufficient degree. For me, the removal of the data cleansing window is a real blow to this objective.
In addition to this, I think it’s now time for the EMA to up its game. Providing such significant updates on webinars alone is simply not good enough. We need detailed, written information to help clarify these changes to the plan, avoid any potential misunderstandings, and provide us with some much-needed clarity.