What DADI means for regulatory submissions

A more data-driven way of managing regulated product data, based on agreed standards, is the future of pharma. But the EMA’s decision means that for now, regulatory teams will have to manually manage data in two repositories – both information populated via DADI web forms, and the fuller data sets held within their own internal RIM systems.

Nevertheless, although the announcement was a disappointment to some, leveraging the parallel DADI project relieves pressure on the pharma industry. DADI, which has been running in parallel with IDMP/SPOR developments, offers an important step towards optimising submissions-handling processes and enabling concrete use of product management services (PMS) master data. Its primary goal is to replace PDF-based e-application forms with web forms submitted via a portal.

DADI 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/integrated from 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 eAF PDF with embedded PMS data in the FHIR XML format.

The timeframe for implementation has also altered. The go-live of the variation web form, originally planned for March 2022 has now been postponed until October 2022. According to the 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, both the use of the web form and the use of structured PMS data will be required.

The final Fast Healthcare Interoperability Resources (FHIR) spec is set to be released in the second quarter of 2022 and 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 Centrally Authorised Products in Step 1 and Non-Centralised in Step 2, as previously planned).

PMS data (migrated from Article57/xEVMPD and EMA’s internal database for Centralised Procedure) will be used in DADI forms. There must be a PMS ID. Missing or incorrect data can be entered, filled or proposed. The PMS will be fed only via the xEVMPD data submission process and that remains unchanged. Having correct data, at least in Article57/xEVMPD or ideally in IDMP granularity, will ease the process of web form-filling.

The EMA says it will share an Excel spreadsheet containing all DADI-applicable data elements soon. However, it will not provide an API at go-live.

The process for MAA submission remains the same, says the EMA. 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.

For the time being, 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 stand them in good stead for the longer-term objective of supporting fuller standards-based data exchange.

They can also continue readying their databases. It is possible right now to take all 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 thorough guidance for users.

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 actually submit the eCTD sequence. This is how the EMA is now implementing the TOM (Target Operating Model), 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 needs to be manually double-entered.

The new agile approach adopted 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, an agile approach should give the industry something to work with sooner rather than later and the DADI project has many elements that are operational right now.

Responding to the EMA’s shift to the DADI project is likely to mark the beginning of a period marked by accelerating change and the need for flexibility from all industry players. In the future, companies will have to look outside their own walls when envisioning the direction of their regulatory solutions. And as data sharing becomes increasingly key to regulatory activities, businesses of all kinds will have to be ready to swiftly pivot and change.

About the author

Renato Rjavec is Director of Product Management, at Amplexor Life Sciences. Amplexor Life Sciences helps organisations that are developing pharmaceutical drugs, medical devices and biotechnology to launch products and break into new markets quickly using end-to-end regulatory and quality management solutions. Its solutions and services expedite the management of highly structured data and the creation and delivery of consistent, compliant global content. Amplexor’s services include technology consultancy, implementation and management services.