Corporate report
MHRA Real-World Evidence Scientific Dialogue Programme
A programme to help facilitate robust decision-making across the entire lifecycle of products, benefitting both regulatory and Health Technology Assessment (HTA) evaluations relevant to the UK.
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The MHRA’s 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.