EMA Consultation on EMRN Data Standards Framework
On 17 August 2026, the European Medicines Agency (EMA) opened a public consultation on the draft European medicines regulatory network (EMRN) Data Standards Framework. The framework supports the mandate of the Network Data Steering Group (NDSG), a joint governance body of the EMA and the Heads of Medicines Agencies (HMA), and proposes a governance framework for the adoption, development, updating and implementation of data standards across the European medicines regulatory network. The scope covers both human and veterinary medicines.
Overview
Authority | EMA and HMA / NDSG |
Date | 17 August 2026 |
Focus | Governance and coordination of regulatory data standardization across the European medicines regulatory network |
Type | Public consultation on a draft data standards framework |
Deadline for comments | 18 September 2026 |
What is this about?
The draft framework is intended to strengthen how the EMRN coordinates data standardization and to provide a more structured process for identifying, evaluating, developing, adopting and implementing data standards.
It builds on the EMRN Data Strategy and supports the European medicines agencies network strategy to 2028, including objectives relating to interoperability, standardization, data quality and appropriate management of network data assets.
According to the draft, previous approaches to data standardization have been fragmented and siloed, contributing to long implementation timelines and limited coordination between standards development, IT system development and business process change. The proposed framework aims to improve governance, transparency and oversight while creating a more predictable and streamlined process.
Although the framework is primarily designed to govern standardization within the EMRN, external stakeholders may also identify and propose relevant use cases for consideration.
Feedback details
The draft framework establishes principles, governance mechanisms and review processes for regulatory data standardization activities across the EMRN.
Key elements include:
Preference for high-quality standards developed through recognized standards development organizations where consistent with EU legislation and regulatory needs
Support for interoperability, data sharing, data protection and data ethics by design
Preference for open standards and avoidance of overlapping or competing standards
International collaboration and harmonization, including engagement with standards organizations such as the International Organization for Standardization (ISO), Health Level Seven International (HL7) and the Clinical Data Interchange Standards Consortium (CDISC), and alignment with international initiatives including the International Council for Harmonization (ICH) and the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH)
A structured NDSG review process for proposals originating from EMRN stakeholders, international harmonization initiatives and standards organizations
Assessment of expected benefits and business outcomes, available standards, affected data assets and IT systems, resource requirements and stakeholder needs when evaluating proposals
Early coordination between data standardization activities, IT system development and business process change initiatives
Clearly defined roles and responsibilities for data standardization leads, data trustees, subject matter experts, standards experts, IT product owners and governance bodies
The draft also includes a proposal template intended to support the prioritization and assessment of future EMRN data standardization initiatives.
Key timeline
Publication: 17 August 2026
Start of consultation: 17 August 2026
Deadline for comments: 18 September 2026
Why this matters
The framework could influence how future regulatory data standards are identified, evaluated, prioritized and implemented across the European medicines regulatory network.
Although focused on regulatory data standardization, the framework may also have broader implications for regulatory processes, IT systems, data governance and change management activities within organizations. The draft explicitly seeks to strengthen the connection between data standards, business processes and supporting IT systems.
The proposed emphasis on internationally recognized standards and alignment with organizations and initiatives such as ISO, HL7, CDISC, ICH and VICH further highlights the importance of interoperability and international harmonization.
The consultation provides stakeholders with an opportunity to provide practical feedback on whether the proposed governance model can support efficient development, adoption and implementation of regulatory data standards across the network.
Who should consider responding?
This consultation may be particularly relevant for:
Pharmaceutical companies with significant regulatory data activities
Veterinary medicines companies and organizations interacting with EMRN regulatory systems
Regulatory information management, master data management and data governance specialists
Organizations implementing ISO-, HL7- or CDISC-based data standards
Regulatory technology, interoperability and digital transformation specialists
Standards development organizations, industry standards groups and industry associations representing affected stakeholders
Practical implications
Stakeholders may wish to consider:
Whether the proposed governance process adequately reflects industry use cases and practical implementation requirements
How the framework could interact with existing regulatory data standards, systems and data management processes
Potential interoperability, implementation, resourcing or change management challenges associated with future standardization initiatives
Whether current or emerging data standardization needs should be highlighted to the EMRN through the consultation process
Whether feedback should be coordinated across regulatory affairs, data governance, standards, digital and IT functions to ensure a comprehensive response
Support with stakeholder responses
We support organizations in:
Assessing the relevance of regulatory feedback opportunities and consultations
Identifying strategic risks and opportunities
Preparing structured and evidence-based responses to authorities
Contact us if you would like to discuss how this consultation may affect your organization or planned regulatory activities.
Note
Check back regularly for updates on EMA, HMA and other international regulatory consultations relevant to the life sciences sector.