MHRA Real-World Evidence Scientific Dialogue Programme
A programme to help decision making across the lifecycle of products, benefitting both regulatory and health technology assessment (HTA) evaluations.
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The pilot phase of the MHRA Real-World Evidence Scientific Dialogue Programme has now concluded. During the pilot four applicants were selected for closed-door, confidential meetings with the MHRA and one for the pre-competitive, ‘safe harbour’, workshop jointly convened by the MHRA and the National Institute for Health and Care Excellence (NICE).
The closed-door meetings covered a wide range of RWE topics, a variety of disease areas and addressed different stages of the product lifecycle. The workshop, meanwhile, focused on the unique challenges and opportunities of using RWD for rare diseases in both regulatory and health technology assessments.
The findings of the pilot are now being assessed and options for continuation being explored. Further updates will follow once the evaluation is complete and recommendations for the next phase are agreed.
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, we are launching a pilot RWE Scientific Dialogue Programme in 2025. This initiative is designed to help innovators refine their evidence generation strategies while providing clear guidance on regulatory expectations.
Updates to this page
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Updated to add text notifying the pilot phase of the MHRA Real-World Evidence Scientific Dialogue Programme has now concluded
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Change to wording in section 5 and new link to updated form and guidance in section 5.
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Changed to add download link to Expression of Interest for the MHRA Real-World Evidence Scientific Dialogue Programme pilot
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First published.