The European Medicines Agency (EMA) has announced that the European Commission’s Up-Scaling the Global Univocal Identification of Medicines (UNICOM) initiative’s Digital Application Dataset Integration (DADI) project will be leveraged to implement regulatory data submissions. Amplexor’s Renato Rjavec looks at what this means for the pharma industry.
Pharma has long needed a more data-driven and standards-based method of managing regulated product data. But following the announcement on DADI by the EMA, it would appear that full identification of medicinal products (IDMP)-based regulatory data exchange, via a system-to-system interface between pharmaceutical companies and the EMA, now has no hope of becoming a reality until after 2023. For the time being, regulatory teams will have to manually manage data in two repositories — information populated via DADI web forms, and the data sets held within their own internal RIM systems.
The announcement is a disappointment for some, but leveraging the parallel DADI project offers a means to maintain progress toward a data-driven submissions management future — e.g., by optimizing submissions-handling processes and enabling the full use of project management services (PMS) master data — and it also relieves pressure on the pharma industry, which was running hard against a deadline.
What is the DADI Project?
DADI, which has been running in parallel with IDMP / substances, products, organizations, referentials (SPOR) developments, offers an important step toward optimizing submissions-handling processes and enabling concrete use of PMS master data. Its main goal is to replace PDF-based e-application forms with web forms submitted via a portal.
However, it does not deliver fluid data exchange. Rather, the DADI portal will support access to current PMS data (to the extent that this has been migrated and integrated from the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD), also known as the Article 57 database, 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 eAF PDF with embedded PMS data in the fast healthcare interoperability resources (FHIR) XML format. However, additional FHIR data import/export API is not planned any time soon.
Six-Month Transition
The EMA has provided plenty of information on the new DADI approach. It says that the go-live of the web form, which was originally planned for March 2022, has now been postponed until October 2022. According to EMA’s DADI eAF Project Q&A, this 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, the use of both the web form and structured PMS data will be required.
The release of the final FHIR specifications is expected for the second quarter of 2022. The DADI project team will create an FHIR specification as the backbone for each of the new web-based forms. Another significant change is that the go-live of the variation web form will be for all EU procedures — not for centrally authorized products in step one and non-centralized in step two as previously planned.
PMS data, migrated from Article 57 / XEVMPD and the EMA’s internal database for centralized procedure, will be used in DADI forms. There must be a PMS ID. Missing or incorrect data can be entered, filled, or proposed. Initially, however, there will be no direct system-based option to submit full product data sets to PMS, and timelines for this are not yet known. The PMS will be fed only via the XEVMPD data submission process, and that 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.
The EMA will share an Excel spreadsheet containing all DADI-applicable data elements in the near future, but it will not provide an API at go-live and has not suggested a timeline for this.
Manual Burden
The process for marketing authorization application (MAA) submission remains the same, says the EMA. The eAF PDF output format will not change, and the PDF is to be linked to the submission, as is the case today. Plans 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 companies will probably still be required to adopt this model eventually.
Falling back on DADI fails to relieve the manual data input burden due to the limited scope of XEVMPD, but, on the other hand, the previous implementation timelines were very tight, and the EMA guidelines and systems in place were not mature enough to guarantee a smooth go-live and productive use.
Better Informed
The EMA’s new approach should keep stakeholders better informed about progress and appears to provide a viable route to achieving tangible outcomes. Companies should still maintain product data that conform 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 of supporting fuller, standards-based data exchange.
Companies can continue to ready their databases. It is possible right now to take all of the relevant information and encode and store it properly in the database. And, of course, this needs to be connected with the RMS-controlled vocabularies. IDMP is complex, so the system should be built to provide guidance so that users are clear when information should be put in the field, as well as any dependencies, constraints, and so on.
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 them to the level that is still needed for XEVMPD submissions. And to support this seamlessly, solutions need to be able to extract information out of the complex IDMP data model to generate the eXtended EudraVigilance Medicinal Product Report Message (XEVPRM) 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 the EMA is now implementing the TOM, where data and content are submitted alongside each other. This is key also for systems to support early collection of data, even though, at this stage, data need to be double-entered manually.
As a result of the changes, it is increasingly important that companies plan to encompass regulatory activities in an end-to-end solution — integrating planning and tracking regulatory activities, safekeeping product registration information, and compiling and publishing eCTD submissions all under one umbrella.
Realistic Outputs
The announcement has been a disappointment to some, but the new agile approach outlined by the EMA is a step in the right direction and has the potential to drive more realistic and tangible outputs in shorter timeframes. Rather than wait for a solution that addresses every requirement, this agile approach should give the industry something to work with sooner rather than later, and the DADI project offers the benefit of having many operational elements right now.
But beyond the immediate challenges of responding to this significant change of tack, there are implications for the data-driven future of the sector. Increasingly, companies will have to look outside their own walls when envisioning the direction of their regulatory solutions. At one time, highly tailored technology solutions were necessary to address the complex individual challenges of organizations. Data sharing looks set to becoming increasingly key to regulatory activities, and, in the future, companies will have to be ready to pivot and change at speed. The EMA’s shift to the DADI project is likely to mark the beginning of a period of accelerating change and need for flexibility, so there is no better time than now to get ready for it.
