The EU’s Iteration 1 of IDMP implementation looked as if it was confirmed and ready to go. But the European Medicines Agency has now announced a change of plan. For the immediate future, the DADI user interface will enable structured data submissions for the EMA PMS. Amy Williams, a Director at Iperion – a Deloitte business – advises what firms should do next.
The European Medicines Agency (EMA) surprised the market in early 2022 by announcing a new plan for the implementation of EU ISO Identification of Medicinal Products (IDMP). Until further notice, the Digital Application Dataset Integration (DADI) user interface, which replaces the electronic Application Form (eAF), will be the vehicle for structured data submissions for the EMA Product Management Service (PMS).
With go-live 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 upmost in companies’ IDMP discussions.
There are clear next steps that companies can take to ensure they adapt without compromising their achievements thus far – and while remaining true to their broader ambitions.
Immediate priorities
The implementation of the EU IDMP has slowly taken shape over time. When the coronavirus epidemic struck, the list of data elements for IDMP was updated to address topical challenges such as drug supply, and 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 centralised authorisation activities. Full IDMP implementation remains firmly on the horizon, and should absolutely remain a consideration for data initiatives. Indeed, the go-live of DADI accelerates the submission of structured PMS data. Although the DADI interface only replaces the eAF, its nomination as a means of submitting data in a structured format offers pharma companies a chance to progress with and test out their PMS/data readiness.
In other words, 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 be prepared, looking towards future IDMP compliance.
There is also a need for readjustment for technology vendors, who have been striving to be ready with IDMP-supporting capabilities. Existing investments are not wasted but a refocus is needed in the interim – for instance on how to manage XEVMPD and IDMP data granularity, and what automations options will be available to facilitate structured data submission.
Expected changes
Here are some specific recommendations for companies as they switch their focus to DADI-based structured data submissions to the EMA PMS.
- Review stakeholders.
- Are the appropriate stakeholders included in discussions for the inclusion of structured data for non-centralised procedures – such as local affiliates? This will depend on who currently manages the relevant data.
- Are sufficient resources in place for the structured data maintenance?
- Get ready for double data submissions. xEVMPD (submissions to EMA’s Extended EudraVigilance Medicinal Product Dictionary) requirements aren’t going away just yet. With the implementation of IDMP Iteration 1, the intention of the target operating model is to cease 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.
- Teams and systems may need to be reconfigured.
- 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 oversee 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.
- At a data management level, capturing and managing the data in a centralised RIM system, so that everything is managed in structured form, could be the appropriate solution for the organisation.
- Assess your options. Implementing DADI could be as easy as replacing existing eAF processes , or could serve as a stepping stone on the IDMP journey for the collection, use and maintenance of structured PMS data, for instance.
A pragmatic approach
Although this shift in requirements might initially feel rather daunting, the most pragmatic approach is to break things down into tangible and actionable decisions and plans.
Where pharma companies already have an IDMP project well underway, and have made good progress preparing for Iteration 1 for centralised procedures, it’s important not to suddenly hit the brakes. Continuing with data remediation activity still makes sense given the scale of transformation that is ultimately required.
Meanwhile, 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 the next phase.
This last-minute change of tack from the EMA gives industry players 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 optimisation of the regulatory process and a reduction in the administrative burden for all stakeholders. Companies that can adapt to the new requirements can set themselves up for a data-driven regulatory management future while remaining true to their own operational ambitions.
About the author
Amy Williams, a Director at Iperion – a Deloitte business, has 15 years of experience in Life Sciences Regulatory Affairs, particularly in optimising regulatory information management systems (RIMs). Iperion, now part of Deloitte, is a globally operating life sciences consultancy firm which is paving the way to digital healthcare, by supporting standardisation and ensuring that the right technology, systems and processes are in place to enable insightful business decision-making and innovation.