Renato Rjavec - Director of Product Management, Amplexor Life Sciences
The European Medicine Agency's (EMA) decision is the latest turn of events in an Identification of Medicinal Products (IDMP) rollout saga that has been dragging on for years. Most industry players agree that a more data-driven way of managing regulated product data, based on agreed standards, is the future for pharma. But full IDMP-based regulatory data exchange, via a system-to-system interface between pharmaceutical companies and EMA, now won’t become a reality until after 2023. For the present, regulatory teams will have to manually manage data in two repositories – information populated via Digital Application Dataset Integration (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 data-driven submissions management future – e.g., by optimizing submissions-handling processes and enabling the full use of Project Management Service (PMS) master data. It also relieves a lot of pressure for the pharmaceutical industry.
Towards Optimization
The DADI project, which has been running in parallel with IDMP/ 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 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 eAF PDF with embedded PMS data in the Fast Health Interoperability Resources (FHIR) XML format.
How It Will Work
The go-live of the variation web form, originally planned for March 2022, has now been postponed until October 2022. According to EMA’s DADI eAF Project Q&A, 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.
The release of the final FHIR spec is expected in the second quarter of 2022. FHIR is a standard for exchanging healthcare information electronically. The DADI project team will create a specification FHIR as 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 Authorized Products in Step 1 and Non-Centralized in Step 2, as previously planned).
PMS data (migrated from Article57/xEVMPD and EMA’s internal database for Centralized Procedure) will be used in DADI forms. A PMS ID must exist. 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 Article57/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 soon. However, EMA will not provide an API at go-live.
A Halfway House
Both pharmaceutical 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 Marketing Authorization Application (MAA) submission will not change, 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. Frustratingly, falling back on the DADI portal for submissions 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 a relief, 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.
A Viable Route
The EMA’s new agile approach seems to provide a viable route to achieving some 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. And, of course, this needs to connect with the RMS controlled vocabularies. IDMP is complex, so the system should be built to provide guidance for users.
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. And 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 the EMA is now implementing the TOM, where data and content are submitted alongside each other. This is a key also for systems to support early collection of data, even though at this stage data needs to be manually double entered.
A Flexible Future
The latest news is just another bump in the long and bumpy 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 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 operational elements right now.
When envisioning the future direction of regulatory solutions, companies will increasingly have to look outwards. As data sharing becomes increasingly key to regulatory activities, businesses will have to be ready to pivot and change very quickly. The EMA’s shift to the DADI project may mark the beginning of a period marked by accelerating change and the need for flexibility, so companies had better be ready.
Renato Rjavec is Director of Product Management, at Amplexor Life Sciences. Amplexor Life Sciences helps organizations 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.
[email protected]; www.amplexorlifesciences.com
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