MHRA-NICE Real-World Evidence Scientific Dialogue
Updated 5 November 2026
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This publication is available at https://www.gov.uk/government/publications/mhra-nice-real-world-evidence-scientific-dialogue/mhra-real-world-evidence-scientific-dialogue-programme
Expressions of interest are now open
Apply for the current submission cycle by 11:59pm 1 February 2027.
Complete the expression of interest (EOI form).
Read guidance on completing the EOI form.
Applicants will be notified of the outcome by mid-March 2027.
Overview
The MHRA and National Institute for Health and Care Excellence (NICE) Real-World Evidence Scientific Dialogue provides a forum for pre-competitive, ‘safe harbour’ workshops on cross-cutting real-world evidence (RWE) topics. The workshops bring together regulators, health technology assessment (HTA) bodies and relevant stakeholders to explore study designs, data sources and analytical methods, clarify expectations and support the generation of robust evidence for regulatory and HTA decision-making.
This supports the MHRA’s Data Strategy ambition to promote data-driven innovation and early access to innovative products through RWE and proactive approaches to safety surveillance.
Following the successful 2025 pilot, the MHRA-NICE RWE Scientific Dialogue runs regular submission cycles each year.
Aims
The aims are to:
- enable strategically focused discussions on RWE, using pre-competitive, ‘safe harbour’ workshops to explore appropriate study designs, data sources and analytical methods to support high-quality RWE generation
- to clarify and promote consistency in regulatory and HTA expectations for RWE, by consolidating and harmonising core methodological principles and evidentiary standards, and addressing key decision points and common challenges across regulatory and HTA contexts
- to increase transparency and shared learning across the ecosystem, by translating workshop discussions into publicly shareable outputs developed collaboratively with partners, including NICE
Structure and timelines
Up to four workshops will be conducted each year, organised into two submission cycles, with two workshops held per cycle.
Applicants are invited to submit an expression of interest during the application window:
- applications open from November to February, with workshops held in May
- applications open from May to August, with workshops held in November
Selected applicants will be invited to a pre-competitive workshop jointly convened by the MHRA and NICE. For topics relating to medical devices, representation from Approved Bodies will be included where relevant. Workshops will be held in a format to be agreed with participating parties. Selected applicants will be expected to work collaboratively with the MHRA to develop the workshop and will also be offered an optional follow-up meeting.
The MHRA will not charge a fee for participating in the MHRA-NICE RWE Scientific Dialogue workshops.
Following each submission cycle, brief, non-confidential discussion summaries will be published. Outputs may also include a peer-reviewed publication, with contributions from participants.
Expression of interest
The MHRA welcomes expressions of interest for the current MHRA-NICE RWE Scientific Dialogue submission cycle.
Applicants should:
Eligibility criteria
The MHRA welcomes expressions of interest for workshops addressing cross-cutting questions relating to RWE. For the purposes of the MHRA-NICE RWE Scientific Dialogue, real-world data (RWD) are data relating to patient health status and/or delivery of health care collected outside of a clinical study.
RWE is evidence derived from the analysis of RWD. Further MHRA resources on RWE are available through the MHRA RWE Knowledge and Guidance Hub.
MHRA-NICE RWE Scientific Dialogue is not intended to provide product-specific regulatory advice. Applicants should also refer to:
Expressions of interest will be excluded if they:
- concern products currently undergoing GB/UK regulatory/HTA procedures such as marketing applications, variations, major safety reviews or other statutory procedures, to preserve regulatory independence
- concern products already being considered through another MHRA pathway, process or programme, such as the Innovative Licensing and Access Pathway (ILAP) or AI Airlock
Selection process
Up to two applications will be selected per submission cycle.
Priority will be given to workshop proposals that address crosscutting RWE questions, support shared learning and guidance development, align with MHRA and NICE public health and innovation priorities, and explore methodologically robust approaches to RWE that are relevant across regulatory, HTA and NHS decision making.
Selection will also seek to ensure diversity across disease areas, product types, stages of product lifecycle, data sources, study designs, and analytical methods.
Contact
If you have any questions about the MHRA-NICE Real-World Evidence Scientific Dialogue, email: rwe@mhra.gov.uk.