Amy Williams is director at Iperion—a Deloitte business.

Amy Williams

Early in 2022, the European Medicines Agency (EMA) announced a new plan for the implementation of the European Union (EU) International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP). The Digital Application Dataset Integration (DADI) user interface, which replaces the electronic Application Form (eAF), will be the vehicle for structured data submissions of EMA Product Management Service (PMS) data and represents a step towards the Target Operating Model.

This latest repositioning on IDMP implementation forces life sciences companies and their technology vendors to reflect on their immediate priorities, in part because DADI-based submissions extend to all EU procedures, rather than just centralized authorization activities.

Full IDMP implementation will still take place eventually and, therefore, continues to be a consideration for data initiatives. The go-live of DADI, set for October 2022, effectively accelerates the submission of structured PMS data. Although the DADI interface only replaces the eAF, its nomination as a means of submitting data in a structured format offers pharma companies a chance to move ahead with their PMS/data readiness. With the data-driven initiatives remaining firmly on the roadmap for regulators, data still needs to be captured and aligned throughout the company and processes adjusted, whatever changes are made to the EMA’s calendar and strategy.

Technology/software vendors, which have been working to get ready with IDMP-supporting capabilities, also need to adjust and refocus—for instance on how to manage the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) and IDMP data granularity, and what automation options will be available to facilitate structured data submission.

The new focus on DADI influences each aspect of a company’s IDMP programmes. If a company is well into the implementation of IDMP, or has a mature data management framework and established data submission processes, it may simply be a case of confirming compliance and availability ready for the September deadline in 2023. The following are some key considerations for discussion for those who have yet to begin implementation.

 DADI takes the first step towards realizing the EMA Target Operating model—tying the submission of data to the regulatory activities. Moving to the DADI webform for the eAF provides companies with an opportunity to evaluate their processes and address questions for DADI from an eAF perspective, taking into account how this interacts with the management of XEVMPD. This will enable them to meet the immediate compliance need without disrupting ongoing IDMP preparations: a fuller overhaul can come later.

 Organization includes data governance, training, and change management. These workstreams are not hugely impacted by the immediate focus on DADI, but the following are some factors to consider:

 Plenty of guidance has already been provided around Substance, Product, Organization, and Referential (SPOR) data specifications in the build-up to IDMP, and it makes sense to continue to lay the foundations of data governance in line with these standards. This will serve not only IDMP Iteration 1, but also DADI and future regulator implementations of IDMP. One needs to decide whether to extend the data governance framework to include the DADI fields—and whether to focus only on the static data elements or also look to standardize the transactional data elements.

 Keeping everyone well informed about the latest changes will be crucial to maintain programme momentum. Inform all stakeholders of the latest revisions to the plan and the impact on deliverables and timescales.

 This remains critical to ensure that everyone understands not just what’s changed in relation to IDMP Iteration 1, but also what the latest developments mean for the various stakeholders, their data, and their processes.

 Technology vendors and service providers are also affected by the latest changes to IDMP implementation and have their own adjustments to make. One immediate challenge is establishing how best to track and manage data across sets of requirements: XEVMPD, IDMP Iteration 1, and beyond—each with its own level of granularity. Ensuring consistency and compliance with the different data models will take careful thought and oversight.

Without the interface/data connector for DADI the reality is that some companies will lose automation capabilities for the population of eAF/DADI in the short term—which also needs to be kept in mind for resource planning.

 Due to the DADI-related requirements for submitting structured data, companies will need to determine what additional data will now need to be collected. Where do the data reside? How much are already tracked within a regulatory information management system or structured format? Is XEVDMP up to date? A further consideration is when and how to factor in additional data fields that will be needed in the next phases.

The shift in requirements requires review and some decisions in the short term, but one can keep moving forward by breaking down the challenge into tangible and actionable decisions and plans.

If an IDMP project is well underway, don’t suddenly stop. Continuing with data remediation still makes sense given the scale of transformation that is ultimately required.

If a company isn’t as far along with IDMP, the new DADI-related requirements may be incorporated for some projects and Iteration 1 compliance may be put off to a later phase.

The changes were a surprise, but they give industry players a chance to take stock of what they are doing, and why, and how far they still have to go. Companies that can adapt to the new requirements while remaining true to their own operational ambitions will be well placed to benefit from a future of data-driven regulatory management.

 is director at Iperion—a Deloitte business


Vol. 34, No. 9
September 2022
Pages: 30–31

When referring to this article, please cite it as A. Williams, “A Change of Tack for IDMP” 

Articles

EMA has announced a change of plan for the IDMP.