Don’t be sidetracked by EMA’s DADI curveball: data is still the goal

Don’t be sidetracked by EMA’s DADI curveball: data is still the goal

by Karmen Umek Luzar |
Jun 20, 2022 |

Yes, the initial plans have altered to buy everyone a bit more time, but the broader plan is still on track – to make product data submissions at least as important as electronic documents (and ultimately the priority/default) in all communications with the regional Regulator.

In other words, whatever tweaks companies and software vendors make to their roadmap and immediate capabilities over the next few months, these should not detract from – nor dilute – the overarching plan to get regulated product data in complete, consistent and up-to-date order.

That’s so that when it is time to migrate to – and go live – with an optimized new regulatory information/submissions management platform or system, there is comprehensive, compliant, high-quality data ready to run across it.

And of course, the foundational work done now will stand companies in good stead for when other regions across the world implement their own take on IDMP – given that dynamic data exchange is where all of this will go, globally, in due course.

What’s changed, and how does it affect you?

To recap what’s changed in the interim, EMA’s Digital Application Dataset Integration (DADI) interface – a project that has been evolving alongside IDMP and SPOR (see https://esubmission.ema.europa.eu/ for more information) – will in the short term, from April 2023, serve as the means for entering electronic application forms through interactive web forms.

This will enable companies to pull data from the PMS (that has been migrated from XEVMPD and other EMA databases) and to get out the human-readable PDF format and machine-readable XML format. Both formats will be submitted along with the eCTD; this part of the process will not change.

This latest development is an important step toward the IDMP goal of reusing data from PMS, and the first step toward the IDMP standardization of data. EMA will support this approach for variation forms only at this point, extending it to initial applications and renewals later.

Ultimately, EMA’s plan is for standardized medicinal product data currently held in the xEVMPD database to be enriched for the PMS, where fuller, more granular, IDMP-compliant medicinal product detail will be kept and updated over time.

There are some practical challenges still to be worked out, such as how IDMP detail that is currently missing will be added to PMS, and how internal company RIM systems and EMA’s PMS database will get to a point of being able to exchange data more seamlessly without requiring manual data re-entry. But for now, this is a chance for companies to update and correct their data with EMA’s dictionary through the familiar XEVMPD process. (Ultimately, FHIR – the global industry standard for passing healthcare data between systems – will support more dynamic data exchange/sync’ing between companies’ RIM systems and EMA’s PMS.)

Rather than play for time, here are 4 opportunities that the interim DADI move makes possible, as well as 5 next steps that companies should take to stay on track with their data preparations:

4 benefits to exploit

  1. The use of the DADI interface for getting data from the EMA PMS allows life sciences companies and software providers to take a breath as they prepare for full-scale IDMP implementation and compliance. FHIR-based submissions via API have been pushed back for now (this will still happen, just not within the next year).
  2. The industry is now less dependent on immediate technology changes. There is no need for their RIM systems to support DADI, as at this point data won’t flow directly between RIM records and EMA’s PMS.
  3. The EMA’s roadmap allows for implementation to happen in manageable chunks. EMA’s ‘DADI first’ approach allows for Product (PMS) data re-use, and accounts for the largest proportion of regulatory submissions.
  4. This is a chance to reset or adapt IDMP/regulatory data strategies, catch up, and prepare to deliver maximum benefits and efficiencies from the preparations (e. g. by doing sufficient groundwork to enable a confident system migration, when the time comes).

5 things to do next, for pharma companies

  1. Set or re-set your strategy and position around regulatory, structured data.
  2. Collect and assess product data and prepare this for compliance (scoping and getting stuck into any data enrichment now) – so that it addresses the granularity of IDMP requirements and maps to EMA’s dictionaries/vocabularies.
  3. Prepare to support xEVMPD e-submissions based on the new data model and all of the levels of detail that are expected, to be ready for the future and to enable a rapid transition to IDMP.
  4. Improve your ability to respond and adapt quickly to further changes to regulatory requirements. EMA’s switch to using DADI to submit data to the PMS highlights just how swiftly the roadmap can change, and why an Agile approach to project management is so important.
  5. Start to migrate your content into the new target system as soon as possible. If you have started with the collection of data in Excel files locally, this data could become outdated if not maintained. Don’t leave thoughts of migration until the last minute. Plan for this now, as part of your overall scoping work.To maximize your IDMP system migration, or discuss your best route to IDMP data preparation as you plan for this, please fill out the contact form below and we’ll put you in touch with our experts.
    Get in touch with us

About the Author

Karmen Umek Luzar followed her Bachelor of Organisational Sciences in IT with a Master of Science in Information Management at the School of Economics and Business at the University of Ljubljana in 2005. Karmen started her professional career in Life Sciences in 2004 as a Consultant for INFOTEHNA/Amplexor Adriatic. In the course of her career at Amplexor she has managed interdisciplinary, or agile teams of 15 people, is highly skilled in writing state-of-the-art technical documentation and has a vast knowledge of software validation. Karmen has 20 years of experience in developing and implementing IT solutions in the Life Sciences industry, focused on RIM, Submission, XEVMPD and IDMP. She joined the Life Sciences Team at fme AG as a Senior Consultant in March 2022.

fme Life Sciences is a leading provider of business and technology services supporting the deployment of Content Services and ECM solutions to its clients in the Life Sciences Industry. We act as a trusted advisor and systems integration specialist across the Clinical, Regulatory and Quality and Manufacturing domains in Europe and North America. We do not exclusively recommend or promote any platform or vendor, but rather we focus on providing our clients with an independent perspective of the solutions available in the market.