Corporate report

Expression of Interest guidance for MHRA-NICE Real-World Evidence Scientific Dialogue

Updated 20 May 2026

  Purpose of this guidance

This guidance document is intended to support applicants wishing to submit an Expression of Interest (EOI) to participate in MHRA-NICE Real-world Evidence (RWE) Scientific Dialogue.

It outlines:

• the objectives and scope of MHRA-NICE RWE Scientific Dialogue
• eligibility and selection considerations
• how to complete each section of the EOI form

Applicants are strongly encouraged to read this guidance before completing the EOI form.

  Overview of the RWE Scientific Dialogue

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. 

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 precompetitive, ‘safe harbour’, workshops jointly convened by the MHRA and the National Institute for Health and Care Excellence (NICE) that enable open discussion on RWE topics.

MHRA-NICE RWE Scientific Dialogue is not intended to provide product-specific regulatory advice. For formal scientific advice, applicants should use the MHRA and NICE existing scientific advice services and pathways.

Aims:  

• To enable strategically focused discussions on real world evidence, 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 health technology assessment 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

Workshop format

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.

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

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

Important dates (current cycle)

• Application window: 20 May 2026 until 11.59pm BST 17 August 2026
• Outcome notifications: the first week of October 2026
• Workshop delivery: November 2026

Following each application cycle, brief non‑confidential discussion summaries will be published. Other workshop outputs may also be agreed and could include peer‑reviewed publications, with participant contributions invited.

The second 2026 submission cycle is expected to start 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 MHRA-NICE RWE Scientific Dialogue, Real-World Data (RWD) 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.

  Completing the EOI Form

The EOI form is completed via the Microsoft Form (available at https://www.gov.uk/government/publications/mhra-real-world-evidence-scientific-dialogue-programme/mhra-real-world-evidence-scientific-dialogue-programme),  and consists of three sections. Guidance for each section is provided below.

A copy of your responses can be downloaded after submission.

Section 1: About you

Lead applicant organisation

Where an application is submitted by multiple organisations, the form should be completed by the lead applicant organisation.

Question 1.2: Organisation category

Applicants should select the category that best describes the lead organisation. The categories and descriptions below are provided to support consistent selection. Where the application is submitted by a consortium, select “Collaborative or consortium‑based partnership”.

Applicant category	Description (who should select this)	Typical characteristics / examples
Commercial industry sponsor	Organisations developing or marketing regulated health products	Pharmaceutical companies, biotech firms, medical device manufacturers, digital health companies
Academic or research institution	Organisations primarily undertaking academic, clinical, or methodological research	Universities, academic research groups, registry‑hosting institutions
Charity or patient‑led organisation	Not‑for‑profit organisations representing patients or funding disease‑focused research	Medical research charities, disease foundations, patient advocacy organisations
Public sector or government‑affiliated body	Organisations operating within or on behalf of public health or government systems	NHS organisations, NIHR infrastructure, public data custodians, government agencies
Technology or data service provider	Organisations providing data, platforms, analytics, or methodologies rather than regulated products	RWE service providers, registry operators, AI / analytics companies
Collaborative or consortium‑based partnership	Joint applications involving multiple organisations or sectors	Public–private partnerships, academic–industry consortia, multi‑sponsor collaborations

If you select “Other”, please provide a brief description.

Section 2: Workshop questions

Question 2.1: Therapeutic area

Please list the relevant disease(s)/condition(s) and/or therapeutic area(s) (e.g. oncology, cardiovascular disease, mental health, rare diseases). If the proposal is not disease‑specific (e.g. methodological or cross‑cutting), please state “Not disease‑specific”.

Question 2.2: Product scope

Please select one of the options provided. This is to help scope the workshop including to determine if representation from the Approved Bodies should be included. Indicate whether the proposal relates primarily to:

• Medicinal products
• Medical devices (including in vitro diagnostic (IVD) devices, digital tools, and software / AI as a medical device (SaMD / AIaMD)
• Both medicines and devices
• Not product‑specific (e.g. data, methodology, or endpoint focused)

Question 2.3: Primary RWE question or uncertainty

This should describe the core RWE issue or decision uncertainty, rather than detailed product/device-specific information. Responses should be no more than 250 words.

Examples of core issues could include feasibility or acceptability of an RWE approach, fitness of a data source, appropriateness of an endpoint, handling of bias/confounding, use of RWE in a specific decision context, sufficiency of data, etc.

In your description, please include:

• the area(s) the proposed discussion relates to (examples include RWD sources, RWE methodology or study design, endpoints, external control arms, pragmatic or hybrid trial designs, computational modelling, etc.)
• the decision(s) the proposed RWE would ultimately be intended to support (examples include regulatory decision-making for medicines, regulatory decision-making for medical devices (including engaging with Approved Bodies), health technology assessment (HTA) or payer decision-making, post authorisation or lifecycle evidence generation and study design, data, or endpoint acceptability across regulators or decisionmakers.)

Question 2.4: Workshop objectives

List 3–5 clear key objectives describing what the workshop is intended to achieve.

For example, objectives could include:

• clarifying regulatory expectations
• exploring methodological options
• identifying key uncertainties
• supporting cross-agency alignment
• informing future guidance

Section 3: Suitability, value, and governance

Question 3.1: Suitability for a precompetitive workshop

Explain why the topic is appropriate for a multistakeholder, precompetitive setting. For example, common challenge, precompetitive learning relevance to multiple stakeholders. Responses should be no more than 150 words.

Question 3.2: Confidentiality considerations

Indicate whether there are any confidentiality constraints that could limit open discussion:

• If no, confirm that discussion can take place at a general or methodological level.
• If yes, briefly outline the nature of the constraints.

Question 3.3: Other considerations

Use this section to raise any additional points, such as timelines, dependencies, ethical considerations, patient involvement, or known limitations. If none, state “None”:

  What happens after submission

The MHRA will confirm receipt of the EOI and email applicants to confirm whether their application is eligible for review. EOIs are reviewed against the eligibility and selection criteria described above. The applicant may be asked to provide additional information where required.

Selected applicants will be contacted and invited to discuss next steps and workshop logistics.

Participants will be expected to agree in advance on the level of information that can be shared publicly through agreed workshop outputs.

  Contact us

For questions about the MHRA-NICE RWE Scientific Dialogue or assistance with your submission, please contact: rwe@mhra.gov.uk