If you are at all familiar with ISO IDMP (Identification of Medicinal Products), you are likely aware that this complex regulatory initiative has been something of a roller-coaster ride for our industry over the last several years. The latest up (or down, depending on your perspective) is the announcement that IDMP efforts by the European Medicines Agency (EMA) will be aligned with an existing EMA information technology initiative known as DADI, or Digital Application Dataset Integration.
While there is still a great deal of uncertainty around what this announcement means for regulatory teams at biopharmaceutical companies, the broad trend towards implementing master data in a structured way across life sciences – including regulatory – is certain to continue. This blog provides a brief summary of what we know about DADI so far, its implications, and how to continue to prepare for the data-driven transformation of regulatory processes.
What is DADI?
The EMA has summarized DADI as follows:
“The Digital Application Dataset Integration Project (DADI) will replace current PDF-based electronic application forms [eAFs] with new web-forms. DADI will replace the form for variations for human medicinal products first in 2022, followed by other submissions forms in 2022-2023 for centrally and nationally authorised products. Introducing new technology for forms is a key step to optimising submissions handling processes and enabling the full use of product management services master data.
The new web-based system will be aligned with EU Implementation Guides for human and veterinary medicinal product data description, using the Fast Healthcare Interoperability Resources (FHIR) data standard, and, as a result, with the EU ISO IDMP (Identification of Medicinal Products) standards implementation for human medicines.” 1
In many ways, the DADI project encapsulates the accelerating movement towards digitalization in our industry, matching the global trend. The EMA sees profound potential benefits to improve population health by enhancing patient safety and enabling industry to bring new therapies to market faster and more cost-effectively – as shown in Figures 1 and 2.
Figure 1. DADI is a critical component of EMA’s Telematics group to drive digital transformation and optimize regulatory processes. 2
Figure 2. Among other sources, the DADI project will draw on product and substances master data from the EMA’s IDMP Product Management Service (PMS). 2
As a result, DADI is now also the primary mechanism for two existing structured data initiatives from the EMA:
- IDMP, based on the four domains of master data in pharmaceutical regulatory processes: Substance, Product, Organization, and Referential (SPOR) data. The new eAF portal will draw on Product Management Service or PMS data (the “P” in SPOR), with Substances, Organization, and Referentials continuing as the planned support framework
- ePI (electronic Product Information)
This blog focuses on the impact of DADI on submissions and IDMP initiatives, with a later blog diving into ePI as more details emerge.
What’s the Impact of DADI for Regulatory Teams?
As noted above, in 2022 the DADI project will replace the current PDF-file based electronic application forms with a new eAF web-based portal, beginning with variations for human medicinal products. In August 2021, the EMA published its latest DADI implementation roadmap (see Figure 3).
The new portal will:
- support both centrally authorized product (CAP) applications and nationally authorized product (NAP) applications
- enable both the familiar human-readable (PDF) output and a new machine-readable output for digital processing based on the FHIR data exchange standard for medicinal products
- use available product master data from Product Management Services (PMS) for human and the Union Product Database (UPD) veterinary medicinal products to prepopulate form fields where relevant
- incorporate the learnings and developments of the Common European Single Submission Portal (CESSP) phase 1 project (which has been folded into DADI)
Figure 3. Timeline as of August 2021 for key DADI milestones.2
What Are the Potential Benefits of DADI?
In many ways DADI is a positive development, since it promises to streamline regulatory processes and harmonize siloed structured data efforts that have been struggling, with IDMP the best example. It will begin to create ongoing efficiencies and process improvements, for example reducing errors and discrepancies that could lead to delays in marketing authorization approval and enable more efficient submissions.
At a higher level, DADI and IDMP also offer drug and device companies a detailed framework to accelerate their digitalization initiatives. Since the new eAF will include a subset of IDMP data and offer the Fast Healthcare Interoperability Resources (FHIR) data standard - which will in time become mandatory, preparing for DADI is a key step towards IDMP readiness.
These preparations provide a valuable opportunity to:
- break down data and process silos
- increase efficiency across R&D, Regulatory and Manufacturing
- respond faster to safety issues and Health Authority communications
- have better visibility into business performance
How to Ensure You’re Prepared for DADI/IDMP
While much is still unknown about DADI, the broad trendline towards digitalization and structured data in regulatory is clear. Based on this trend and what we know so far about DADI, following are recommendations for key readiness steps you can take today:
- Understand the data that will be utilized by the new DADI eAF portal, and how it will be utilized.
The DADI PDF will be submitted via eCTD. While xEVMPD can still be used, the EMA is examining data flow from/to xEVMPD with DADI and across other databases. It is a matter of when, not if, xEVMPD is replaced by IDMP. It will thus be critical to identify your data sources across the organization and assess the differences between the data submitted in xEVMPD versus what will be required for DADI and IDMP.
- Test extraction of your source data and assess its quality.
We recommend that you collect sample data from existing sources (e.g., from xEVMPD/RIM as well as from unstructured sources such as SmPCs) to determine the level of difficulty in obtaining the data that will be needed for utilizing the DADI web forms. As part of this effort, you can define clear roles and responsibilities around who is responsible for managing and extracting the data; assess the quality of the extracted data; perform a gap analysis to determine whether any data is missing; understand how that data maps to the new requirements; and remediate any quality issues or data gaps.
- Evaluate your regulatory business processes and technologies.
If you have marketing-authorized products in the EU, DADI presents an opportunity to evaluate your regulatory processes and technologies holistically to improve regulatory information management. Leverage DADI and IDMP to examine and improve your master data strategy, since you will need to be able to manage the data from multiple sources with a concept of data lifecycle management. In this sense, it’s helpful to think of the SPOR Target Operating Model (TOM) not just as technical guidance but also as business guidance.
Phlexglobal is helping life sciences companies advance their clinical and regulatory digitalization initiatives, including DADI/IDMP readiness, through technology innovation backed by deep subject matter expertise. Contact us today with any questions or challenges you have regarding DADI/IDMP or any other regulatory initiative – we’ll be happy to help.
- DADI eAF Project Q&A: http://esubmission.ema.europa.eu/cessp/DADI%20Questions%20and%20Answers.pdf
- Summary of the Digital Application Dataset Integration Project (DADI) for partners and stakeholders: http://esubmission.ema.europa.eu/cessp/DADI%20Project%20summary%20presentation.pdf