UK's MHRA launches call for epidemiological studies using CPRD to support regulatory priorities

The UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has opened a call for epidemiological research proposals using Clinical Practice Research Datalink (CPRD) data, inviting academic institutions to address priority regulatory questions and strengthen evidence generation for medicines and medical device oversight.

Successful applicants will receive infrastructure support rather than direct research funding. This includes free access to a Standard 12-month CPRD Single-Study License Workspace with VM credits and approved data linkages. Studies will be conducted within CPRD Safe, the program’s trusted research environment, which enables secure analysis of linked datasets such as Hospital Episode Statistics, mortality records, and deprivation indices.

This emphasis on secure data access comes amid increased scrutiny of secondary data governance, following a recent UK Biobank data governance incident.

The call reflects the MHRA’s continued reliance on real-world evidence (RWE) to inform regulatory decisions. CPRD contains longitudinal healthcare data derived from UK primary care and supports research examining the safety and effectiveness of medicines and medical devices. The MHRA noted that it “relies on robust real-world evidence to support medicines and devices regulation in the UK,” highlighting the role of large-scale observational data in supporting patient safety and public health.

Proposals must address at least one strategic priority area identified by the MHRA. These include:

• Proactive pharmacovigilance: Development of proactive safety monitoring approaches, such as methods for near real-time signal detection using electronic health records (EHRs) or techniques including Prescription Symmetry Sequence Analysis (PSSA).
• Underserved populations: Studies identifying and characterizing differences in medicine or device safety across population groups, including variations by ethnicity, geography, or socioeconomic status.
• Effectiveness and safety in real-world populations: Analyses comparing real-world effectiveness and safety outcomes with clinical trial results to better understand how medicines perform in routine clinical practice.
• Children and pregnant women: Research using EHRs to evaluate the safety and effectiveness of medicines in populations that are often excluded from clinical trials.
• Safety of medical devices: Innovative studies exploring new ways to assess medical device safety using CPRD data, where evidence remains more limited than for medicines.

Applicants may also propose alternative CPRD-feasible topics aligned with MHRA strategic priorities, including safety, effectiveness, risk minimization, and health inequalities related to medical products regulation.

Selected projects will be required to produce a comprehensive final report summarizing study methods, findings, limitations, and regulatory relevance. Researchers must also provide reproducible, well-documented analytical code through an open-access repository to support transparency and reuse. According to the MHRA, the initiative aims to “stimulate research that addresses key regulatory questions and contributes to proactive surveillance, patient safety, and public health priorities.”

Applications should outline the scientific rationale, study objectives, data requirements, and methodological approach, including strategies for bias minimization and statistical analysis, alongside feasibility considerations such as sample size, expected events, timelines, anticipated outputs, and regulatory relevance. Applications are due by 31 May 2026, with outcomes expected following panel review by 31 July 2026, after which successful applicants will proceed through CPRD’s standard Research Data Governance processes before initiating their studies.