Renato Rjavec is director of product management at Amplexor Life Sciences.

Renato Rjavec 

The saga of identification of medicinal products (IDMP) rollout has been dragging on for years, and the latest decision by the European Medicines Agency (EMA)—to focus on Digital Application Dataset Integration (DADI) project first—is only the latest bump in the road (1). Most industry players agree that a more data-driven way of managing regulated product data, based on agreed standards, is the future for the pharmaceutical industry. But EMA’s change of heart means that full IDMP-based regulatory data exchange, via a system-to-system interface between pharmaceutical companies and EMA, now won’t come into effect any time soon. For the time being, regulatory teams will have to manually manage data in two repositories—information populated via DADI web forms and the fuller data sets held within their own internal regulatory information management (RIM) systems.

Leveraging the parallel DADI project offers a means to maintain progress towards a future of data-driven submissions management (e.g., by optimizing submissions-handling processes and enabling the full use of product management services [PMS] master data). It also relieves a lot of pressure for the pharmaceutical industry.

The DADI project, which has been running in parallel with IDMP/substance, product, organization, and referential (SPOR) developments, offers an important step towards optimizing submissions-handling processes and enabling concrete use of PMS master data. Its primary goal is to replace PDF-based e-application forms with web forms submitted via a portal.

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 the extended EudraVigilance medicinal product dictionary [XEVMPD] and other EMA databases). It will also support the entry of suggested PMS data changes (initially only for variations of existing products in the PMS) and the generation of an electronic application form (eAF) PDF with embedded PMS data in the Fast Healthcare Interoperability Resources (FHIR) XML format. FHIR is a standard for exchanging healthcare information electronically. The DADI project team will create a specification FHIR as a backbone for each of the new web-based forms.

The go-live of the variation web form was originally planned for March 2022, but it has now been postponed until October 2022 (2). According to EMA’s DADI eAF project Q&A (3), the project go-live will be followed by a six-month transition period, during which both the PDF eAF and the web-based form can be used in parallel. At the end of the transition period, both the use of the web-form and the use of structured PMS data will be required. Another significant change is that 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 with the EU IDMP roadmap).

PMS data (migrated from Article 57/XEVMPD and EMA’s internal database for centralized procedure) will be used in DADI forms. Missing or incorrect data can be entered, filled, or proposed. Initially, though, there will be no direct system-based option to submit full product datasets to PMS and timelines for this are not yet known. The PMS will be fed only via the XEVMPD data submission process, which remains unchanged. Having correct data, at least in Article 57/XEVMPD or ideally in IDMP granularity, will ease or speed up the process of web form‑filling.

EMA will share a spreadsheet containing all DADI-applicable data elements in the near future. However, EMA will not provide an application programming interface at go-live.

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.

However, the process for a marketing authorization application submission will not change, says the EMA (4). 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, though it is still expected that companies will eventually be required to adopt this model. Falling back on the DADI portal for submissions will fail to alleviate the manual data input burden due to the limited scope of XEVMPD. Meanwhile, the developments have also come as a relief, as the previous implementation timelines were tight, and the maturity of the EMA guidelines and systems in place was insufficient to guarantee a smooth go-live and productive use.

EMA’s new agile approach seems to provide a viable route to achieving tangible outcomes in the near future. Companies should still maintain product data that conforms to the data granularity requirements of IDMP as well as XEVMPD electronic submissions based on these standards. This will put them in good stead for the longer-term objective: supporting fuller standards-based data exchange.

Companies can continue to get their databases ready. It is possible right now to take all the relevant information and encode and store it properly in the database. Of course, this needs to be connected with the referentials management services controlled vocabularies. IDMP is complex; therefore, the system should be built to provide guidance for those using it.

In the past, companies collected data in the granularity required by the XEVMPD. Now, there is a crucial requirement to be able to trim down data collected in IDMP granularity and convert it to the level that is still needed for XEVMPD submissions. To support this seamlessly, solutions need to be able to extract information out of the complex IDMP data model to generate the XEVPRM message in the appropriate format.

Companies can also continue with work on connecting processes, keeping in mind an impending process change that demands that companies submit a certain set of information to the data form before they submit the eCTD sequence. This is how EMA is now implementing the TOM, where data and content are submitted alongside each other. This is also a key for systems to support the early collection of data, even though at this stage data needs to be manually double-entered.

The latest news is just another bump in the long and troubled road of IDMP. But this new agile approach is a step in the right direction and could drive more realistic and tangible outputs in shorter time frames. Rather than wait for a solution that addresses every requirement, an agile approach should give the industry something to work with sooner rather than later, and many of the DADI project’s elements are operational right now.

As regulatory solutions change, data sharing will increasingly become key to regulatory activities, and businesses will have to be ready to pivot and change very quickly. EMA’s shift in priority to the DADI project may mark the beginning of a period marked by accelerating change and the need for flexibility. As such, companies should be prepared.

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When referring to this article, please cite it as F. Thomas, “What DADI Means for the Pharmaceutical Industry,” 

Articles

The move toward using the Digital Application Dataset Integration (DADI) project for the initial implementation of IDMP-based regulatory data submissions offers both opportunities and challenges for pharmaceutical organizations.