By Amy Williams, Iperion – a Deloitte business
Just when the life sciences industry was as sure as it could be that EU Iteration 1 of ISO Identification of Medicinal Products (IDMP) implementation for centralized procedures in Europe was confirmed and ready to go, the European Medicines Agency announced a change of plan. Until further notice, the Digital Application Dataset Integration (DADI) user interface, originally designated as a replacement for the electronic Application Form (eAF), will be used to enable structured data submissions for the EMA Product Management Service (PMS).
With go-live of this approach planned for October 2022, companies have until April 2023 to adopt DADI. Fitting DADI into an IDMP strategy — especially for those that have already invested considerable resources and budget in preparing for IDMP Iteration 1 submissions — is now uppermost in companies’ IDMP discussions.
There are clear next steps companies can take to ensure they adapt without compromising their achievements thus far — and whilst remaining true to their broader ambitions.
How Does This Confusion Lead To Opportunity?
The evolution of the EU IDMP implementation has become more concrete incrementally. With the pandemic, we saw the list of data elements for IDMP updated to address topical challenges such as drug supply. In the wake of the pandemic, momentum around IDMP implementation/data submissions was building accordingly: the EU Implementation Guide 2.0; then 2.1; then plans for the imminent release of 2.2.
This latest repositioning requires that life sciences companies and their technology vendors take a step back to reflect on their immediate priorities, not least because DADI-based submissions extend to all EU procedures, not just centralized authorization activities.
Full IDMP implementation remains firmly on the horizon and should remain a consideration for data initiatives, however. Indeed, the go-live of DADI accelerates the submission of structured PMS data. Although the DADI interface ultimately only replaces the eAF, its nomination as a means of submitting data in a structured format does offer pharma companies a chance to progress with — and test — their PMS data readiness.
This is a step forward and progress is tangible. Data-driven processes remain the end goal, data still needs to be captured from documents and aligned throughout the company, and companies still need to prepare for all of this, looking towards future IDMP compliance.
For technology vendors, which have been striving to be ready with IDMP-supporting capabilities, there is a need for readjustment too. Existing investments are not wasted, but a refocus is needed in the interim, for instance, on how to manage EMA’s Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) and IDMP data granularity, and what automation options will be available to facilitate structured data submission.
Adjustments To Expect
Below are some specific recommendations as companies switch their focus to DADI-based structured data submissions.
- Are the appropriate stakeholders included in discussions for the inclusion of structured data for non-centralized procedures (non-CAPs), such as local affiliates? This will depend on who manages the relevant data currently.
- Are sufficient resources in place for the structured data maintenance?
Be prepared for double data submissions.
xEVMPD requirements aren’t going away just yet. With the implementation of IDMP Iteration 1, the intention of the target operating model is to cease the submissions of xEVMPD. However, xEVMPD will be retained, at least for now. Companies will submit first via DADI as part of the submission package and then again for xEVMPD, post approval.
Be ready to reconfigure teams and systems.
- Up to now, eAF preparation at many companies has fallen under the remit of regulatory affairs rather than regulatory operations or regulatory information management (RIM) teams. Now that DADI is becoming something more than a straight replacement for the eAF, companies need to consider whether it still makes sense for RA teams to look after this process, or whether use of data stewards within regulatory ops/management — to collect and govern the structured data required for the submissions — would be more appropriate and cost efficient.
- From a data management level, capturing and managing the data in a centralized RIM system, so that everything is managed in structured form, could be the appropriate solution for the organization.
Remember that there are choices.
The implementation of DADI could be as easy as replacing existing eAF processes or serve as a stepping-stone on the IDMP journey for the collection, use, and maintenance of structured PMS data, for instance.
Maintaining Perspective & Momentum
The new shift in requirements needs an immediate review and decision in the short term. The most pragmatic approach will be to break down the challenge into more tangible and actionable decisions and plans, making it possible to keep moving forward.
Where pharma companies already have an IDMP project well underway and have made good progress preparing for Iteration 1 for centralized procedures, it’s important not to suddenly press “stop”. Continuing with data remediation activity still makes sense given the scale of transformation that is ultimately required.
Those companies that aren’t as far along with their IDMP activities may be able to redirect their projects, reframing them to incorporate the new DADI-related requirements at this stage and pushing out Iteration 1 compliance to a later phase.
Ultimately, the latest changes provide the industry with a chance to take stock of what they are doing, and why, and how far they still have to go. The changes required to implement structured data submissions for DADI compliance are not insurmountable. The end objective should still be optimization of the regulatory process and reduction in the administrative burden for all stakeholders. Companies that adapt to the new requirements while remaining true to their own operational ambitions will set themselves up well for a data-driven regulatory management future.
About the Author:
Amy Williams, a director at Iperion - a Deloitte business, has 15 years of experience in life sciences regulatory affairs, particularly in optimizing regulatory information management systems (RIMs). Iperion is a globally operating life sciences consultancy firm. Williams can be reached at firstname.lastname@example.org.