Corporate report

MHRA Real-World Evidence Scientific Dialogue Programme

Updated 12 March 2025

1. Overview

The MHRA data strategy sets out an ambition to promote data-driven innovation and early access to innovative products through real-world evidence (RWE) and proactive approaches to safety surveillance. In support of this, the MHRA is launching a pilot RWE Scientific Dialogue Programme during 2025.

This initiative is designed to help innovators refine their evidence generation strategies while providing clear guidance on regulatory expectations. The programme aims to facilitate robust decision making across the entire lifecycle of products, benefitting both regulatory and health technology assessment (HTA) evaluations relevant to the UK.

The pilot phase of the RWE Scientific Dialogue Programme will be run during 2025. Selected applicants will gain access to:

• a closed-door, confidential virtual meeting with the MHRA to address commercially sensitive discussion focusing on RWE topics pertinent to medicinal product development
• a pre-competitive, ‘safe harbour’, workshop jointly convened by the MHRA and the National Institute for Health and Care Excellence (NICE) - this environment promotes open dialogue and shared learning about RWE topics

The MHRA will not charge fees for the pilot phase of the RWE Scientific Dialogue Programme.

2. Aims of the Real-World Evidence Scientific Dialogue Programme:

• to clearly set out the MHRA expectations for RWE methodologies for evidence generation through consolidation and harmonisation of core principles, and to produce specific use cases - this should ensure the evidence generated will uphold the MHRA rigorous standards for evaluating safety, quality and efficacy/effectiveness, promoting public health and protecting patient safety
• to enable commercially sensitive discussions between applicants and the MHRA, with a specific strategic focus on RWE, enhancing existing scientific advice services
• to increase clarity of regulatory and HTA expectations for data, analytical methodologies, and endpoints used to generate RWE
• to generate shared learning which can be disseminated to the broader ecosystem through reflection papers developed collaboratively between the MHRA, NICE, and industry stakeholders

3. Eligibility criteria

The MHRA welcomes expressions of interest related to any proposal with a specific focus on RWE. For the purposes of the RWE Scientific Dialogue Programme, real-world data (RWD) is defined as data relating to patient health status and/or delivery of healthcare collected outside of a clinical study and RWE is defined as evidence derived from the analysis of RWD.

The RWE Scientific Dialogue Programme invites applications for:

• medicinal products including drugs, biologics, vaccines, and advanced therapy medicinal products (ATMPs)
• pre- and post-authorisation evidence generation
• evidence generation relative to claims of both effectiveness and safety
• interventional and non-interventional studies including:
  • external control arm studies
  • pragmatic clinical trials
  • pharmacoepidemiological studies (for example, cohort studies, case-control studies, and other observational designs)

For the pilot programme, we will not consider expressions of interest for medical devices. For clarity, we are only including medicinal products that are regulated through the medicine’s pathway.

Additionally, proposals involving products under active regulatory procedures (for example, marketing applications, variations, major safety reviews or other statutory procedures), will also be excluded to maintain regulatory independence.

4. Selection process

A limited number of applications will be accepted while the RWE Scientific Dialogue Programme is in a pilot phase. The selection process is designed to ensure a diverse representation of disease areas, medicinal product types, and stages of authorisation.

Priority will be given to applications that focus on:

• addressing pressing public health challenges, aligning with broader government policy
• areas of significant unmet clinical need
• preventative medicine, interpreted broadly
• genomic data, biomarkers, or precision medicine approaches
• innovative methodologies or study designs that advance the field (for example, improving representativeness in clinical studies, measuring effectiveness through RWD)

Applications which are not selected may be offered advice through the MHRA’s existing scientific advice services.

5. Expression of interest

The pilot MHRA Real-World Evidence Scientific Dialogue Programme expression of interest call is now closed. Please do not submit an application for the pilot MHRA Real-World Evidence Scientific Dialogue Programme.

6. Timeline

If an expression of interest is selected to proceed, the applicant will be requested to provide more detailed information on the questions, format, and content of the proposed discussion. Before approving workshop requests, the applicant must reach an agreement with the MHRA and NICE on what information can be shared publicly.

Expressions of interest will be accepted from 10 February 2025 until 11.59pm BST 4 April 2025. The MHRA will review submissions and notify applicants of the outcome in the first week of May 2025.

All meetings with the selected applicants will be held virtually during May and July 2025. The workshop will be hosted in June/July 2025, in a format to be finalised in consultation with by all participating parties.

7. Contact us

If you have any questions about the programme or need assistance with your submission, email scientific_advice@mhra.gov.uk, including the subject line “RWE Scientific Dialogue Programme”.