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10 FEBRUARY 2025 – The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a programme to help decision-making across the lifecycle of products, benefitting both regulatory and health technology assessment (HTA) evaluations [Link] [1].
Overview
The MHRA’s Data Strategy [2] 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 [3].
The pilot phase of the RWE Scientific Dialogue Programme will be run during 2025. Selected applicants will gain access to [3]:
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- 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.
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The MHRA will not charge fees for the pilot phase of the RWE Scientific Dialogue Programme.
Aims of the Real-World Evidence Scientific Dialogue Programme
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- To clearly set out the MHRA’s 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 MHRAs 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 MHRA, NICE, and industry stakeholders.
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Eligibility Criteria
The RWE Scientific Dialogue Programme invites applications for [3]:
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- 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 (e.g., cohort studies, case-control studies, and other observational designs).
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For the pilot programme, expressions of interest for medical devices will not be considered. . For clarity the MHRA are only including medicinal products that are regulated through the medicine’s pathway [3].
Additionally, proposals involving products under active regulatory procedures (e.g. marketing applications, variations, major safety reviews or other statutory procedures), will also be excluded to maintain regulatory independence [3].
Expression of Interest
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 [3].
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 [3].
The expression of interest guidance and form can be downloaded here from the 10th February 2025 and should be emailed to scientific_advice@mhra.gov.uk, including the subject line “RWE Scientific Dialogue Programme.”
References
1. MHRA Real-World Evidence Scientific Dialogue Programme
Link: https://www.gov.uk/government/publications/mhra-real-world-evidence-scientific-dialogue-programme
2. MHRA Data Strategy 2024 -2027
3. MHRA Real-World Evidence Scientific Dialogue Programme – Corporate Report (10 February 2025)
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