EMA and HMA Open Consultation on EMRN Data Standards Framework

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have opened a public consultation on a draft framework for governing data standards across the European medicines regulatory network (EMRN). The draft EMRN Data Standards Framework (EMA/185661/2026) sets out how the network will adopt, create, update, and implement data standards for human and veterinary medicines regulation. Stakeholders can submit comments through an EUSurvey form until 18 September 2026.

What the EMRN data standards framework sets out

The framework supports the mandate of the Network Data Steering Group (NDSG), the joint HMA-EMA body responsible for interoperability and data exchange. It forms part of the NDSG work plan and backs Theme 2 of the European medicines agencies network strategy to 2028. That theme includes the goal of ensuring a high level of interoperability, standardisation, and data quality while addressing potential biases and ethical considerations.

It builds on the EMRN Data Standardisation Strategy, which the Big Data Steering Group and the EU Network Databoard co-authored earlier. That document identified where data standardisation would deliver the most benefit. The new framework turns those priorities into a governance process.

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The draft notes that developing and implementing standards has historically taken more time and resources than expected. By defining roles and responsibilities and moving away from a siloed, ad hoc approach, it aims to deliver more standards in a shorter timeframe and to close the gap between standards development, IT systems development, and business process change.

Seven guiding principles

The framework lists seven principles. They call for the use of high-quality standards from accredited standards development organisations instead of local or proprietary standards where possible. The principles also require data protection and ethics to be built into standards by design, support for open standards, checks of new requirements against standards already in use to avoid overlap, agreement on common international standards, and reuse of terminologies already in use across the EMRN.

Three routes for proposals

The review process differs depending on where a proposal begins. EMRN members and stakeholders complete the NDSG template in Annex 1 and name a lead person. The NDSG can approve the proposal, approve it with amendments, reject it, or defer it. ICH and VICH topic proposals that include a data standard follow a faster review, coordinated with the ICH coordinators for the European Commission, because the window between circulation and a decision is often short. Work items from standards development organisations are triaged by EMRN SDO experts and escalated to the NDSG secretariat when they affect standards the network already uses.

Who does what

The framework defines roles and responsibilities for nine parties. These include a Data Standardisation Lead appointed by the NDSG, a Data Trustee for each affected data asset, subject matter experts, the NDSG secretariat, SDO experts, IT product owners, the NDSG itself, the network portfolio, and the ICH coordinator. The intention is that IT systems development and business process change begin alongside standardisation work rather than after it.

Comments must be submitted through the EUSurvey form. The consultation runs from 17 August 2026 to 18 September 2026. The NDSG reviewed the draft on 15 July 2026 and its comments were addressed on 3 August 2026. Contact details are available on the EMA and HMA websites.