With EU IDMP 2.0, life sciences companies need to be on the lookout. Check how you can maximize efficiency of your regulatory submission processes.
At the 2021 virtual BE THE EXPERT 2021, Frits Stulp, Managing Director of Iperion, provided tips on the steps life sciences companies can take now to fully capitalize on EU implementation of IDMP, following the latest guidance.
The publication of EU IDMP version 2.0 implementation guidance in early 2021 has restarted the clock for life sciences companies targeting Europe to rethink the way they manage marketing authorization submissions – in such a way that brings them new operational efficiencies, while boosting the quality of the information provided to regulators.
The new Target Operating Model, around preparing and making submissions, offers some important opportunities for Regulatory Information Management and Publishing teams to coordinate their activities more closely. Here is a chance to reduce duplication of effort and to ensure greater consistency between the dossiers and covering information submitted and the story told by the underlying source data.
Pass the mustard: seize every data opportunity
Under XEVMPD, the pre-cursor to IDMP, data is submitted to EMA but a long time after the fact – beyond the point of marketing authorization having been awarded. As the Dutch might say, this has been a case of ‘mustard after the meal’ (something that could have been of value being served up too late).
In IDMP-compliant scenarios, master product data and document-based dossiers will be submitted simultaneously, and it will be expected that the content is interchangeable, free from anomalies (which would now be that much more obvious, potentially causing issues – not least reduced regulator confidence in the information).
The regulatory data continuum
The evolution from PDF-based electronic application forms (eAFs) currently uploaded via the CESSP e-submission portal, to the now-approved Digital Application Dataset Integration (DADI) project which will succeed it, feeds into this more streamlined and data-centric information management scenario, easing the form-filling and submission-handling process for all parties.
The point being that it makes no sense at all now for teams to persist in treating document and data-based submissions as distinct tasks, each approached more or less from scratch. Here, once and for all, is a chance for economies of scale, for default to a master source of product ‘truth’, from which any kind of submission can be generated semi-automatically, without risk of calling in or copying across old or incorrect information.
Keeping the submission end goals in sight
It’s deeply important to keep in mind why all of these changes have been devised, especially when trying to cost-justify new compliance projects.
The whole point of submitting data once to the regulator, and have it used in all relevant use cases, is to facilitate searching of information and make it more useful. We’re not too far now from a scenario where there will be more of a rolling review of products via a cloud-based platform, that can be followed online via a self-service mechanism. EMA may not have been very proactive in promoting this vision, nor the many new use cases for reliable centralized data on all available and emerging products, but they exist in abundance.
With the EU’s latest IDMP implementation guidance now readily accessible, and this data-driven process transformation vision within reach, life sciences companies are in a strong position to vet the software tools on the market and assess how far these will take them towards a more streamlined approach to regulatory submissions.
Questions to ask software vendors, something I have expanded on in my session at BE THE EXPERT 2021, include:
- Can the software handle both XEVMPD and IDMP product management services/submissions?
- Can you demonstrate its support for the new Target Operating Model, in particular parallel variations and data submissions, and a global data model which allows for regional interpretations?
- Is it able to support the HL7 Fast Healthcare Interoperability Resources (FHIR) messaging standard?
Managing Director of Iperion Life Sciences Consultancy
About the author
Frits Stulp is the Managing Director of Iperion Life Sciences Consultancy. He has been the Program Manager of the first completed IDMP implementation program, and also a member of the EMA ISO IDMP Task Force.