Get integrated scientific advice from the MHRA and NICE for medicines

23rd February 2026

Summary: This guidance explains how sponsors of new medicines can request integrated scientific advice from the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) to support efficient development and evaluation. The combined service is designed to help companies understand both regulatory requirements (safety, quality, efficacy) and health technology assessment (HTA) expectations (cost-effectiveness and real-world value) in a single, coordinated interaction. Integrated advice can cover clinical development plans, selection of appropriate comparators, trial design, evidence generation strategies, endpoints that support both regulatory approval and reimbursement decisions, and adaptive pathways where applicable. By engaging with MHRA and NICE early — for example before pivotal trials are finalised — developers can reduce duplication, anticipate evidence needs for market access, and align regulatory and reimbursement strategies for the UK.

Link: https://www.gov.uk/guidance/medicines-get-integrated-scientific-advice-from-the-mhra-and-nice

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