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MHRA Expands Guidance and Initiatives on Real-World Evidence

lite News Desk 2 min read

At a glance

  • MHRA published a Real-World Evidence guidance hub in October 2026.
  • Guidance covers use of real-world data in UK regulatory decisions.
  • Scientific Dialogue programme launched with NICE in January 2025.

The Medicines and Healthcare products Regulatory Agency (MHRA) has taken several steps to support the use of real-world data (RWD) and real-world evidence (RWE) in UK regulatory processes for medicines and medical devices. These efforts are reflected in recent publications, consultations, and collaborative programmes.

On 9 October 2026, the MHRA published the “MHRA Real-World Evidence: knowledge and guidance” hub. This resource brings together the agency’s guidance, publications, and resources on RWD and RWE for regulatory decision-making.

According to the MHRA, RWD refers to information on patient health or healthcare delivery that is collected outside of clinical studies. RWE is defined as the insights generated from analysing RWD, which can be used to inform decisions about the safety and effectiveness of medicines and devices.

The agency’s Data Strategy for 2024-2027 outlines continued development of guidance on RWD and RWE. The strategy also includes a Scientific Dialogue Programme to assist innovators in generating evidence and aims to engage with stakeholders and international regulators to promote harmonisation of guidance.

What the numbers show

  • The Real-World Evidence guidance hub was published on 9 October 2026.
  • Guidance on using RWD in clinical studies was published in December 2021.
  • A consultation on draft guidelines for external control arms ran from 20 May to 14 July 2025.
  • The Scientific Dialogue programme pilot launched in January 2025 and concluded in early 2026.

In December 2021, the MHRA published guidance on the use of RWD in clinical studies to support regulatory decisions. This included recommendations for conducting randomised controlled trials (RCTs) that incorporate real-world data.

Between May and July 2025, the MHRA ran a consultation on a draft guideline for using external control arms based on RWD. This consultation sought input on how such data could be used to support regulatory decisions for medicines and medical devices.

The MHRA and the National Institute for Health and Care Excellence (NICE) launched the Real-World Evidence Scientific Dialogue programme pilot in January 2025. The pilot aimed to support both regulatory and health technology assessment (HTA) decision-making by providing a forum for dialogue on the use of RWE.

The pilot phase of the Scientific Dialogue programme concluded in early 2026. Following its conclusion, the programme transitioned to ongoing workshops, with updates to the initiative published by September 2026.

* This article is based on publicly available information at the time of writing.

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