Practical implication
Regulatory Intelligence teams should monitor the outcomes of these consultations and update relevant standard operating procedures (SOPs) regarding data governance and reporting, ensuring compliance with new guidelines post-consultation.
The EMA has initiated a public consultation phase starting from August 17, 2026, to September 18, 2026, involving the Draft EMRN Data Standards Framework. This initiative aims to enhance data standardisation processes within the European medicines regulatory network.
What changed: The EMA established a public consultation period for the Draft EMRN Data Standards Framework, which will enable stakeholders to contribute to the development of data standardisation principles that are vital for regulatory processes.
Why it matters: Engagement in these consultations allows stakeholders to influence regulatory guidance and practices, thereby ensuring that the data standardisation approaches align with industry needs and foster better quality and interoperability of data across the regulatory landscape.
Practical implication: Regulatory Intelligence teams should monitor the outcomes of these consultations and update relevant standard operating procedures (SOPs) regarding data governance and reporting, ensuring compliance with new guidelines post-consultation.
View original source
- Source: EMA - News
- Published at source: 2026-09-11T12:00:00.000Z
- Discovered by monitor: 2026-09-11T21:34:00.295Z
Published from the regulator source ingestion pipeline after PV impact triage.
