The European Medicines Agency (EMA) has published a data protection notice for its Modelling and Simulation Pilot, which involves the use of clinical study data for scientific advice. The notice, issued on 7 May 2026, outlines how EMA will process personal data in this pilot, which aims to leverage modelling and simulation to support regulatory decision-making. The pilot is expected to impact pharmaceutical companies and researchers who submit clinical data, as well as patients whose data may be used.
The document is a data protection notice under the General Data Protection Regulation (GDPR). It specifies that EMA acts as the data controller for the processing of personal data contained in clinical study datasets submitted voluntarily by marketing authorisation holders or applicants. The notice is a mandatory transparency requirement, not a policy recommendation, and does not set numerical targets.
The pilot seeks to explore how modelling and simulation can inform scientific advice, potentially reducing the need for additional clinical trials and accelerating drug development. However, it raises trade-offs between innovation and data privacy: while the initiative may enhance regulatory efficiency and reduce patient exposure to experimental treatments, it also involves processing sensitive health data, requiring robust safeguards. The notice details data retention periods, access controls, and the rights of data subjects.
Stakeholders impacted include pharmaceutical companies, who may benefit from streamlined advice but face administrative burdens in anonymising data; patients, whose privacy is protected but whose data may be used without direct consent under certain legal bases; EMA itself, which must ensure compliance with data protection laws; and national competent authorities, which may receive aggregated results. The notice does not specify expected institutional follow-up, but EMA will likely evaluate the pilot's outcomes and may issue further guidance or expand the initiative based on results.
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