Corporate report

MHRA-NICE Real-World Evidence Scientific Dialogue

Updated 20 May 2026

Overview

In 2025, the MHRA conducted a Real-World Evidence Scientific Dialogue programme (RWE SDP) pilot to assess whether early, structured regulatory engagement could support better evidence generation. This initiative aimed to foster collaboration between regulators and applicants, facilitating robust decision-making for both regulatory and health technology assessment (HTA) purposes.

During the pilot four applicants participated in closed-door, confidential meetings with the MHRA and a precompetitive, ‘safe harbour’, workshop jointly convened by the MHRA and the National Institute for Health and Care Excellence (NICE). The confidential meetings addressed product-specific and commercially sensitive RWE topics, a variety of disease areas and addressed different stages of the product lifecycle. The workshop focused on the unique challenges and opportunities of using Real-World Data (RWD) for rare diseases in both regulatory and health technology assessments. 

The pilot demonstrated the value of early dialogue, highlighted the need for clearer regulatory expectations, and showed the benefits of workshop-based engagement for aligning stakeholders.

Following the pilot the MHRA is continuing with RWE Scientific Dialogue through ongoing workshops that enable open discussion on RWE topics whilst continuing to exploring the integration of RWE advice into existing MHRA services. 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.

The MHRA-NICE RWE Scientific Dialogue will now accept applications relating to RWE and medical devices, with representation from Approved Bodies in relevant workshops.

Aims

• To enable strategically focused discussions on RWE, using precompetitive, ‘safe harbour’ workshops to explore appropriate study designs, data sources and analytical methodologies 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 by addressing key decision points and common challenges relevant to both 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

Four workshops will be conducted each year, organised into two application cycles with two workshops scheduled per cycle. Selected applicants will be invited to a precompetitive workshop jointly convened with the MHRA and NICE (with Approved Bodies representation for applications on devices) with an optional follow-up meeting also offered.

The MHRA will not charge fees for MHRA-NICE RWE Scientific Dialogue workshops.

For the current cycle, expressions of interest for a workshop will be accepted from 20 May 2026 until 11.59pm BST 17 August 2026. The MHRA will review submissions and notify applicants of the outcome in the first week of October.

The workshop will be hosted in November 2026, in a format to be finalised in consultation with all participating parties.

Following each application cycle, brief non‑confidential discussion summaries will be made available. Outputs may also include a peer‑reviewed publication, with participant contributions invited.

The second 2026 submission cycle is expected to launch in November 2026.

Eligibility Criteria

The MHRA welcomes expressions of interest related to any proposal with a specific focus on RWE. For the purposes of the RWE Scientific Dialogue, Real-World Data is defined as data relating to patient health status and/or delivery of health care collected outside of a clinical study and RWE is defined as evidence derived from the analysis of RWD.

Expressions of interest will be excluded if they:

• involve products currently undergoing GB/UK regulatory/HTA procedures (e.g. marketing applications, variations, major safety reviews or other statutory procedures), to preserve regulatory independence
• are already in an MHRA pathway or process, such as the Innovative Licensing and Access Pathway (ILAP), Innovative Devices Access Pathway (IDAP), or regulatory programme (e.g., AI Airlock)

Selection Process

Up to two applications will be selected per submission cycle.

Priority will be given to workshop proposals that address cross‑cutting 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. The selection process will focus on ensuring diversity across disease areas, medicinal product types, stages of authorisation, and also among data sources, study designs, and analytical methods.

Applications which are not selected may still seek advice through the MHRA and NICE existing scientific advice services and pathways.

Expression of Interest

The MHRA welcomes submissions for participation in MHRA-NICE RWE Scientific Dialogue.

The expression of interest form can be accessed from the 20 May 2026.

See our expression of interest guidance for applicants.

Please note that applications will not be accepted after 11.59pm BST 17 August 2026.

If an expression of interest is selected to proceed, the applicant will be contacted and requested to provide more detailed information on the questions, format, and content of the proposed discussion. To promote transparency and awareness the participants in the workshops must agree on the level of information to be disclosed in publicly shareable learning outputs that inform the wider ecosystem.

Contact

If you have any questions about the MHRA-NICE Real-World Evidence Scientific Dialogue or need assistance with your submission, please email: rwe@mhra.gov.uk.