The big DADI switch: EMA’s 11th-hour IDMP rethink and what it means for data-based regulatory submissions

by Renato Rjavec | Mar 9, 2022 | Blog

Tags: IDMP

Learn more about the latest EMA’s IDMP rethink and how that will affect data-based regulatory submissions.

At the beginning of this year the European Medicines Agency (EMA) finally broke cover and publicly confirmed the rumours that had been spreading over the preceding months. The DADI (Digital Application Dataset Integration) project will now serve as a ‘Plan B’ to initiate the implementation of regulatory data submissions based on FHIR format. At the eleventh hour, this has been deemed the only way to achieve PMS go-live.

For pharma companies and software vendors, this is the latest setback – not to mention shock turn of events – in an IDMP implementation saga that has been dragging on for years. Everyone accepts that a more data-driven way of managing regulated product data, based on agreed standards, is the future. Yet, preparing for this brave new tomorrow has already cost many companies a fortune.

Although leveraging the parallel DADI project (which replaces PDF-based e-application forms with web forms submitted via a portal) does offer synergies and means to maintain progress, EMA’s decision is also bitterly disappointing. It means that, for at least for the foreseeable future, regulatory teams will have to manage data in two repositories (the information populated via DADI web forms, and the comprehensive data sets held within their own internal RIM systems), entering the input for each manually. While FHIR-based structured information will be embedded in the eAF file exportable from DADI portal, full regulatory data exchange between companies and the EMA PMS via a system-to-system software interface in FHIR format won’t become a reality until after 2023.

Who’s the DADI?

The DADI project, which has been running in parallel with IDMP/SPOR developments, offers an important step towards optimizing submissions handling processes and enabling the full use of product management services (PMS) master data.

What DADI does not deliver, however, is fluid data exchange. Rather, the DADI portal will support:

  • Access to current PMS data (to the extent that this has been migrated/integrated from XEVMPD and other EMA databases);
  • The entry of suggested PMS data changes (initially only for variations of existing products in the PMS);
  • Generation of an eAF PDF with embedded PMS data in the FHIR XML format.

Unfortunately, this is where progress ends in the short term: additional FHIR data import/export interface is not planned any time soon.

Recognising the need to provide clarity after months of uncertainty and silence, EMA scheduled two webinars in January to explain the change in approach and provide some details about the revised plans and guidelines. One of these sessions included a live demo of the web form under development. In February, EMA published the updated DADI Roadmap and updated its FAQ document. The next demo session is already scheduled for March.

Key learnings

The key takeaways of the EMA’s DADI communications to date are summarized below:

  1. The go-live of the variation web form was originally planned for March 2022 but has now been postponed until October 2022, to be followed by a minimum 6-month transition period in which parallel use of old and new forms is permitted;
  2. In parallel, web forms for initial applications and renewals will be developed with an anticipated timeline stretching beyond 2023 (but this is not yet clearly defined);
  3. Release of the final FHIR spec is expected in Q2/2022;
  4. The go-live of the variation web form will be for all EU procedures (not Centrally Authorized Products in Step 1 and Non-Centralized in Step 2, as previously planned);
  5. PMS data (migrated from Article57/xEVMPD and EMA’s internal database for Centralized Procedure) will be used in DADI forms;
  6. Missing or incorrect data can be entered/filled/proposed. Initially, though, there will be no PMS feedback (and timelines for this are not yet known): the PMS will be fed only via the xEVMPD data submission process which remains unchanged;
  7. Having correct data in Article57/xEVMPD will ease or speed up the process of web form-filling;
  8. EMA will share an Excel spreadsheet containing all DADI-applicable data elements soon;
  9. EMA will not provide an API at go-live: no timelines for this have been communicated.

What does all of this mean in practice?

EMA has emphasized that the entire process for MAA submission will not change. The eAF PDF output format will not change, and the PDF is to be linked to the submission as is the case today.

Ambitions to move towards the proposed new IDMP/SPOR-based target operating model (TOM) based on data-driven product information exchange have been watered down, at least in the short term. It is still expected that companies will eventually be required to adopt this model but by when is not known.

Even though the benefits of a portal and web forms over the current eAF/PDF approach are important, the deployment of DADI in place of the planned-for FHIR data submission has come as a shock to the industry and to the technology vendors working towards compliant data-based solutions.

Both pharma companies and vendors have been working around the clock to deliver against the previously communicated plans, based on EU IDMP Implementation Guidance v2.1, only to find that the direction has changed abruptly – with little or no warning. It’s also not clear when the next revision of the EU IDMP IG will be published.

Frustratingly, these latest developments will hamper fuller process transformation for now. Falling back on the DADI portal for submissions (and even then, only for reporting variations) will fail to alleviate the manual data input burden due to the limited scope of XEVMPD.

On the other hand, the developments have also come as something of a relief to the industry and to vendors, as the previous implementation timelines were very tight and the maturity of the EMA guidelines and systems in place was not sufficient to guarantee a smooth go-live and productive use.

As the dust settles, the EMA’s new agile approach seems to provide a viable route to achieving some tangible outcomes in the near future, and keeping stakeholders better informed about progress.

How to respond – and how Amplexor LS can help

The important thing for the industry now is to maintain product data that conforms to the data granularity requirements of IDMP, as well as XEVMPD electronic submissions based on these standards. This will keep companies in good stead for the longer-term objectives: supporting fuller standards-based data exchange.

Rest assured that Amplexor Life Sciences Suite fully supports the latest DADI requirements. We are also continuously and carefully monitoring the situation so that we can respond swiftly to any further changes. Certainly we are primed to support our pharma industry clients as they adjust their plans for a data-driven regulatory future.

Agnes Cwienczek

Agnes Cwienczek

Head of Product Management & Consulting

About the author

Agnes has been in the position of ALSS Head of Product Management and
Consulting since May 2017. Her main responsibilities are the contribution to
the development and enhancement of the Amplexor Life Sciences Suite,
supervision of the Life Sciences Consultants as well as the provision of
business process and data management expertise to Amplexor clients in
Regulatory Information Management, Document Management, and
Submission Management.