Corporate report

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.

From:
Medicines and Healthcare products Regulatory Agency
Published
13 January 2025
Last updated
12 March 2025 — See all updates

Documents

MHRA Real-World Evidence Scientific Dialogue Programme

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Expression of Interest for the MHRA Real-World Evidence Scientific Dialogue Programme pilot

MS Word Document, 92.4 KB

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Details

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

Published 13 January 2025
Last updated 12 March 2025 show all updates

  1. Change to wording in section 5 and new link to updated form and guidance in section 5.

  2. Changed to add download link to Expression of Interest for the MHRA Real-World Evidence Scientific Dialogue Programme pilot

  3. First published.

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