- The European Medicines Agency (EMA) has published a new Data Protection Notice outlining how clinical study data will be processed as part of its Modelling and Simulation Pilot initiative. The pilot reflects EMA’s growing focus on advanced data analytics and pharmacometric modelling to strengthen regulatory decision-making and scientific advice for medicines intended for human use.
- According to the EMA, the purpose of this processing operation is to enable the Agency to make use of data relating to the safety and efficacy of medicines while strengthening its modelling and simulation capabilities. The initiative is designed to support the delivery of the best possible scientific advice during the evaluation of medicinal products, informed by relevant regulatory precedents and evidence-based analyses.
- The Data Protection Notice describes several personal data processing activities that will be carried out during the pilot, with a strong focus on data extraction and analysis. These activities include:
- Extraction of clinical study data from the electronic Common Technical Document (eCTD);
- Aggregation of pseudonymised clinical study participants’ data;
- Creation and storage of datasets across therapeutic indications and/or clinical study participant subgroups, including paediatric and elderly populations;
- Analysis involving the development of pharmacometric meta-analytic models based on aggregated datasets;
- Dissemination of modelling and simulation results using only anonymised personal data to support regulatory decision-making.
- The EMA clarified that the personal data processed under the pilot are submitted by applicants or marketing authorisation holders (MAHs) in pseudonymised form as part of medicines regulatory applications, including initial marketing authorisation applications (iMAAs) and post-authorisation procedures.
- Importantly, the Agency emphasized that the pseudonymisation process ensures the data cannot be attributed to an identified or identifiable natural person without additional information. EMA further stated that such additional identifying information is neither held nor processed by the Agency, reinforcing compliance with European data protection requirements and privacy safeguards.
- The Modelling and Simulation Pilot represents an important step toward integrating advanced computational methods into medicines regulation. By enabling the aggregation and analysis of clinical data across multiple therapeutic areas and patient populations, the initiative could help improve dose optimization, extrapolation strategies, and evidence generation for underrepresented groups such as paediatric and elderly patients.
- The Data Protection Notice also specifies the retention and access framework for the pilot. According to EMA, data associated with the Modelling and Simulation Pilot will be retained for a period of five years from the date of publication of the pilot results. Access to the personal data is restricted internally to authorized staff within the EMA Human Medicines Division, particularly within the Scientific Advice Office.
- As regulatory agencies increasingly adopt data-driven methodologies, the EMA’s initiative highlights the growing importance of balancing scientific innovation with robust data governance and privacy protection. The pilot could serve as a foundation for future regulatory modelling frameworks that support more efficient and evidence-based medicine development across Europe.
May 11, 2026
