The European Medicines Agency (EMA) has published the minutes of the HMA-EMA joint Network Data Steering Group (NDSG) meeting held on 15 April 2026. The document outlines discussions on data governance, real-world evidence (RWE) methodologies, and the progress of the Data Analytics and Real-World Interrogation Network (DARWIN EU) initiative, impacting pharmaceutical companies, national competent authorities, and healthcare data holders.
The minutes, released on 1 June 2026, cover the NDSG's 15 April meeting and detail decisions on data quality standards and the prioritisation of RWE studies. The group, which coordinates data activities across the European medicines regulatory network, reviewed updates on the DARWIN EU project, which aims to provide timely and reliable evidence from real-world healthcare data for regulatory decision-making.
Policy orientations and trade-offs
The NDSG discussed the balance between expanding access to real-world data for regulatory purposes and ensuring robust data privacy and security. Members emphasised the need for standardised data quality frameworks to enable cross-border data sharing while maintaining compliance with the General Data Protection Regulation (GDPR). The group also considered the trade-off between accelerating RWE study timelines and ensuring methodological rigour, particularly for studies intended to support marketing authorisation or post-authorisation safety monitoring.
Impact on stakeholders
Pharmaceutical companies may benefit from clearer guidance on acceptable RWE sources and study designs, potentially reducing uncertainty in regulatory submissions. However, they may face increased costs to align internal data systems with the network's evolving standards. National competent authorities will need to allocate resources to implement common data quality criteria and contribute to DARWIN EU studies. Healthcare data holders, such as hospitals and registries, could see greater demand for their data but must navigate complex consent and anonymisation requirements.
Expected institutional follow-up
The NDSG is expected to finalise a set of data quality recommendations by the end of 2026, with pilot testing in selected therapeutic areas. EMA will also issue a reflection paper on the use of RWE in regulatory decision-making, building on the discussions captured in these minutes.
← Atlas › News › Health & Lifestyle