UK’s MHRA launches RWE hub to help researchers and developers navigate regulatory guidance

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a Real-World Evidence Knowledge and Guidance Hub, bringing together guidance, publications and scientific advice pathways to support the use of real-world data in UK regulatory decision-making.

The Baseline

• The hub provides a central resource for guidance and supporting materials on real-world data and real-world evidence for medicines and medical devices.
• Resources cover randomized trials using RWD, draft guidance on external control arms and international methodological standards.
• It also signposts opportunities to discuss evidence-generation plans with the MHRA and NICE, including scientific advice services and RWE scientific dialogue workshops.

The MHRA has published a dedicated RWE Knowledge and Guidance Hub, providing researchers, healthcare professionals, developers and other stakeholders with a central starting point for navigating the regulatory use of real-world data (RWD) and real-world evidence (RWE). Launched on October 9, 2026, the hub consolidates guidance, publications and engagement opportunities relevant to medicines and medical devices in the UK.

Among the resources are the agency’s 2021 guidance on assessing whether RWD sources are suitable for their intended use and on designing randomized controlled trials using RWD. The hub also links to its draft guidance on external control arms, published for consultation in May 2025. That document outlines considerations for sponsors planning trials that use patient-level data collected outside a clinical study as a comparator, with some principles also relevant to controls drawn from previous trials.

The hub lists several MHRA-endorsed guidelines, including ICH M14, which addresses the planning, design, analysis and reporting of non-interventional studies using RWD to assess medicines safety. Its recommendations emphasize assessing whether data are fit-for-purpose and using feasibility assessments to inform and refine study design. It also highlights the MHRA’s contribution to ICH E23, the guideline under development on using RWE to inform regulatory decisions, with a focus on medicines effectiveness.

Beyond methodological guidance, the hub includes the MHRA’s July 2026 paper on its data requirements, which sets out the infrastructure needed to support its regulatory activities. The paper identifies gaps in data access, linkage and coverage, and outlines how the planned UK Health Data Research Service (HDRS) could help address them.

Alongside these resources, the hub directs developers to opportunities for early engagement across the agency. These include Integrated Scientific Advice from the MHRA and the National Institute for Health and Care Excellence (NICE), which provides coordinated advice on evidence requirements for marketing authorization and health technology assessment (HTA) through a single process, helping developers shape plans that address both organizations’ needs.

Complementing this advice on development plans, the MHRA–NICE RWE Scientific Dialogue offers opportunities to explore broader methodological questions through precompetitive workshops on study designs, data sources and analytical approaches. Following a 2025 pilot, the program supports shared learning across regulatory and HTA settings and now accepts proposals relating to medical devices.