RegulatoryGuideline · final

MHRA launches hub gathering its real-world evidence guidance and resources in one place

🇬🇧 MHRA · Fri 09 Oct 2026

The UK regulator has published a knowledge and guidance hub on real-world data and evidence use in regulatory decision-making for medicines and medical devices.

The Medicines and Healthcare products Regulatory Agency (MHRA) published a Real-World Evidence Knowledge and Guidance Hub on 9 October 2026. The page collects the agency's guidance, publications and resources on using real-world data (RWD) and real-world evidence (RWE) in UK regulatory decision-making.

The MHRA says the hub covers both medicines and medical devices. It is aimed at researchers, healthcare professionals, industry, patients and other stakeholders interested in how RWE is generated and used.

The page restates the agency's working definitions. RWD means data on patient health status or the delivery of health care that are collected outside a clinical study. When such data are analysed, the resulting information may be called RWE.

The page was updated on the day of publication to add a link to a data requirements page. The source text does not detail what that page contains, and the hub itself appears to act as a signposting resource rather than setting out new requirements.

What it means for your team

  • Regulatory teams can use the hub as a single starting point to locate current MHRA material on RWD and RWE, rather than searching across separate pages.
  • The MHRA's definitions of RWD and RWE are stated on the page and should be checked against terminology used in study protocols and submissions to the UK.
  • The linked data requirements page should be reviewed by teams planning RWE-based work, as it was added on launch day.
  • The hub covers medicines and medical devices, so it is relevant to both product types.

Official guideline text: MHRA ↗

Article written by VigiEye from the official source (MHRA). AI-assisted; check the source before acting.

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