The EU Road to reach interoperability across regulatory systems: are you in step with the new EMA standards and regulatory systems?

by: Paola Cinquanta, Operations Manager – Regulatory Affairs & Senior Associate Partner @PQE Group

Regulators push to establish a high level of interoperability across global regulatory and healthcare communities. The social demand for higher and higher levels of health care, constant improvement of quality of life and better medicines puts a positive pressure on the healthcare and pharmaceutical systems. Global health emergencies contribute to amplifying the natural urge for health care and high-quality therapeutic solutions to be rapidly made available. The development of new medicines and improvement of existing ones requires new tools to evaluate and predict the efficacy and safety of medical products. However, the development of such tools requires collaboration and effective data sharing (Thompson et al., 2021). In this landscape, the value of an effective data exchange is priceless. Thus, interoperability of regulatory information systems takes on the value of an essential requirement for regulatory bodies.

Interoperability guarantees different information systems to access, integrate information, share and cooperatively use data in a coordinated manner, within and across organizational, regional and national boundaries, to provide timely and seamless portability of information and optimize the health of individuals and populations globally (HIMSS Definition). The primary expectations in sharing databases is to ensure consistency of data in national and central databases, minimize additional administrative burdens to keep data synchronized between national authorities and enable the automatization of data exchange.

EU Road_banner insight

Interoperability: next steps

The first step towards the interoperability of regulatory information systems is the definition of standards for data and systems. Standards provide a common language and a common set of expectations that enable interoperability between systems.

The European Medicines Agency (EMA) started its multi-year programme, which defines a Master Data Management (MDM) strategy for the use of medicinal product data specifically related to Substance, Product, Organisation and Referential (SPOR) data. SPOR services cover the four domains of master data:

The criterion applied to these steps assumes that:

  • Substance Management Service to uniquely identify the constituents of medicinal products;
  • Product Management Service to uniquely identify medicinal products;
  • Organization Management Service to uniquely identify an organization acting in the pharmaceutical environment;
  • Referential Management Service which includes controlled vocabularies to describe attributes of products.

SPOR data management services will facilitate the reliable exchange of medicinal product information in a robust and consistent manner, fully in line with the “one-stop-shop” approach to have a single comprehensive source of data via one service.

Implementing the ISO IDMP Standards

Thus, EMA is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). The IDMP standards specify standardized definitions for the identification and description of medicinal products and aim to facilitate the reliable exchange of medicinal product information, ensuring wide interoperability across global regulatory and healthcare communities (EMA website). SPOR services supports the implementation of ISO IDMP standards in the EU / EEA.

EMA is establishing new tools which will be key to integrating and optimizing regulatory procedure management, such as the electronic Product Information (ePI) project, the ISPOC to support proper oversight and management of shortages of critical medicines in Europe and the Digital Application Dataset Integration (DADI) which will replace the technology for electronic applications forms (eAF) for data sharing during regulatory activities. DADI was announced by EMA as the tool enabling structured data submissions; indeed the eAF will be substituted by web-based forms in a dedicated portal integrating product management services (PMS) structured product data.

EMA recently accelerated implementation of its Target Operating Model: the new DADI forms will be released, one form at a time, starting in 2022. The first release of the web-based variation form for human medicinal products is planned to be announced in October 2022. It will be limited to Centrally Authorised Products (CAPs) and the related data will come from EMA’s internal database. The second release, foreseen in March 2023, will support all types of EU variations procedures, including National Procedures (NP), Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) as well as mixed CAP/NAP work-sharing procedures. The transition period when both PDF eAF and the web-based forms can be used in parallel will last for six months, which means starting in September 2023, the use of DADI web-based forms will be mandatory and PDF eAF will no longer be supported. DADI implementation will also represent a check point for pharmaceutical companies to test operability of their product management services and IDMP data readiness.

The implementation of DADI represents another step in the EMA roadmap to reach the full interoperability of regulatory information systems on medicines in the European Union and European Economic Area. In this fast-moving context, readiness of your company data and regulatory systems for IDMP implementation is essential, but it represents only the first element on the way to compliance, ensuring the company communication channel with EMA and other European Regulatory Bodies will always be fully operative.
Adoption of the new DADI web-based forms requires review of the company’s processes. Furthermore, organization of data inside the company, data governance and data change management must always be considered, taking advantage of the work already done and work in progress for IDMP readiness. The time is now: companies have the opportunity to work on internal policies and data standards to secure the data management process is fully covered all the way to the DADI exchange of information with regulatory bodies.

The EMA is moving quickly to establish well integrated and interoperable regulatory information systems. Systems integration will allow reduction of data silos and improvements in interoperability across EU systems are expected to bring operational excellence and more efficient and timely exchanges of consistent and valuable data in line with data integrity principles. Other regulatory bodies worldwide are working in the direction of data standardization and interoperability of regulatory information systems, from the US FDA to the Japanese MHLW, passing through the Eurasian Economic Union.

Being ready for the change

This environment represents a continuous challenge for pharmaceutical companies shifting and adapting their operations and systems to face the new regulatory trends. IT systems must be adapted to match requirements of the increasingly complex, always-evolving regulatory environment. Economic investments are required. Company policies and procedures must be rapidly and effectively adapted to new operations systems.
Make clear where your organization is, determine your goal and set an agile project plan to quickly adapt your organization (quality system, documents and data management) and infrastructure to be data management ready for IDMP new requirements and the newly established interoperable regulatory information systems.


Are you ready for change?

PQE Group can support your business in reaching the compliance for your products as well as in implementing new procedures, tools and software.

To get more information or support, get in touch with us  or check our Quality Compliance dedicate page to find the most suitable solution for your company.

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