EMA and HMA Open Consultation on the EMRN Data Standards Framework

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have opened a public consultation on a draft EMRN data standards framework, the governance document that will shape how the European medicines regulatory network adopts, creates, updates, and implements data standards for human and veterinary medicines.

The draft, published under reference EMA/185661/2026 and dated 1 July 2026, is open for comment from 17 August to 18 September 2026. Responses go through an EUSurvey form linked in the consultation notice.

The EMRN data standards framework and its purpose

The framework supports the Network Data Steering Group (NDSG), which holds the mandate to enable interoperability and data exchange through common international standards and to support international collaboration, alignment, and harmonisation with bodies such as ICH, VICH, HL7, ISO, and CDISC.

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It sits within the NDSG work plan and backs Theme 2 of the European medicines agencies network strategy (EMANS) 2028, including goal 1.2, which calls for a high level of interoperability, standardisation, and data quality while addressing potential biases and ethical considerations. It builds on the earlier EMRN Data Standardisation Strategy co-authored by the Big Data Steering Group and the EU Network Databoard.

How data standardisation works

Data standardisation means representing data in a common format so different systems can exchange and understand it. Standards usually bring together terms, definitions, controlled vocabularies, and logical data models for semantic interoperability, alongside message exchange formats for technical interoperability. Once in place, standardisation makes it easier to exchange, manage, and analyse data, and to apply artificial intelligence.

The framework sets out seven principles. Among them: use high-quality standards from accredited standards development organisations unless EU law makes that impractical; support data sharing, data protection, and data ethics by design; favour open standards; and check new proposals against what is already in use to avoid overlapping or competing standards, covering both human and veterinary needs where possible.

Who develops the standards

Standards normally come from standards development organisations (SDOs) such as ISO, HL7, and CDISC, each with its own membership rules and processes. The framework describes how the NDSG reviews standardisation proposals from three sources: the EMRN and its stakeholders, ICH/VICH topic proposals that include data exchange, and SDO work item proposals. ICH and VICH are not SDOs themselves; they work with SDOs to produce implementation guides that add business rules for international data exchange.

Each proposal needs a lead person and must describe the use cases, expected benefits, engagement plan, sponsors, and resources. The NDSG can approve a proposal, approve it with amendments, defer it for more information, or turn it down.

Replacing a fragmented process

The framework is designed to replace what the draft calls a “siloed ad hoc approach” to standardisation. Development, implementation, and business benefits have taken longer than expected in the past, and the document aims to make the process more accessible and efficient by defining clear roles, responsibilities, and objectives.

Roles span a data standardisation lead, data trustee, subject matter experts, the NDSG secretariat, SDO experts, IT product owners, and the network portfolio. The draft also stresses planning IT systems from the start of standards development, so that standards are not disconnected from the systems and business processes that will manage the data.