MHRA and NICE launch real world evidence scientific dialogue

21st May 2026

Summary:
The MHRA and NICE have introduced a new scientific dialogue process focused on the use of real world evidence (RWE) to support regulatory and health technology assessment decisions. The initiative is designed to provide developers with early, coordinated advice on how to generate and use RWE effectively across the product lifecycle. By aligning expectations between regulators and assessors, the dialogue aims to reduce uncertainty, improve evidence generation strategies, and ultimately speed up patient access to innovative medicines. The approach highlights the growing importance of real world data in complementing clinical trials and supporting more adaptive, evidence based decision making in the UK.

Link: https://www.gov.uk/government/publications/mhra-nice-real-world-evidence-scientific-dialogue

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