The European Medicines Agency (EMA) has published a record of data processing activity for its Modelling and Simulation Pilot, detailing how clinical study data will be used for scientific advice. The document, dated 7 May 2026, outlines the agency's approach to handling patient-level data from clinical trials to support regulatory decisions through modelling and simulation techniques.
The record specifies that the pilot aims to explore the use of existing clinical study data to generate evidence for scientific advice procedures, potentially reducing the need for additional trials. It covers data categories, retention periods, and access controls, with the stated goal of ensuring compliance with data protection regulations. The document is a transparency measure under the EU's General Data Protection Regulation, listing EMA as the data controller.
Policy orientations and trade-offs
The pilot balances innovation in regulatory science against data privacy and security. By reusing clinical data, EMA could accelerate drug development and reduce costs for pharmaceutical companies. However, this raises concerns about patient consent and data anonymisation. The record emphasises that only pseudonymised data will be used, and patients have the right to object to processing. Critics may argue that the scope of data reuse remains vague, potentially leading to mission creep.
Impact on stakeholders
Pharmaceutical companies stand to benefit from streamlined scientific advice, potentially lowering development timelines and costs. Patients may see faster access to new medicines but face privacy risks if anonymisation proves insufficient. EMA itself gains efficiency and expertise in modelling, but must invest in secure data infrastructure. National competent authorities may need to align their own data practices with this pilot.
Expected institutional follow-up
The pilot is expected to run for a defined period, after which EMA will evaluate outcomes and consider broader implementation. Stakeholders have been invited to provide feedback, and the agency may issue further guidance on data reuse standards. The record will be updated as the pilot evolves.