MHRA and NICE invite proposals for RWE scientific dialogue

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) have opened applications for the next round of their joint Real-World Evidence Scientific Dialogue workshops. The initiative seeks proposals addressing methodological challenges in using RWE to inform regulatory and health technology assessment decisions for medicines and medical devices.

The Baseline

• The MHRA and NICE have opened applications for the next round of their joint Real-World Evidence Scientific Dialogue workshops.
• The initiative provides a forum to address methodological challenges in using real-world evidence for regulatory and health technology assessment decisions.
• Proposals covering medicines and medical devices are invited, with expressions of interest open until February 1, 2027.

Following a pilot in 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) established the Real-World Evidence (RWE) Scientific Dialogue as an ongoing program of workshops addressing methodological challenges in evidence generation for regulatory and health technology assessment (HTA) decision-making. The initiative provides a pre-competitive, “safe harbor” forum for regulators, HTA bodies and other stakeholders to examine study designs, data sources, and analytical approaches, with the aim of clarifying evidentiary expectations and supporting greater consistency in RWE assessment.

The current submission cycle invites proposals addressing “cross-cutting RWE challenges,” particularly those exploring new approaches to using real-world data (RWD). Priority will be given to topics that support shared learning, align with MHRA and NICE priorities for public health and innovation, and examine methodologically robust approaches relevant to regulatory, HTA and NHS decision-making. The selection process will also consider diversity across disease areas, product types, lifecycle stages, data sources, study designs, and analytical methods.

Up to four workshops will be held annually, with a maximum of two proposals selected during each of the program's two submission cycles. Applications received between November and February will be considered for workshops in May, while those submitted between May and August will be considered for workshops in November. Successful applicants will work with the MHRA to develop the workshops, which will be jointly convened with NICE. Approved Bodies will be included where relevant to medical device proposals. Participation is free, and applicants will also be offered an optional follow-up meeting.

The workshops are intended to address broader methodological questions rather than provide product-specific regulatory advice. To preserve regulatory independence, the initiative excludes proposals concerning products undergoing active UK regulatory or HTA procedures, including marketing authorization applications, variations, and major safety reviews. Products already being considered through other MHRA programs, such as the Innovative Licensing and Access Pathway (ILAP) or AI Airlock, are also ineligible.

The initiative’s expansion following the pilot introduced revised application procedures and extended its scope to include medical devices alongside medicines. The initiative also aligns with the MHRA’s Data Strategy 2024–2027, which identifies RWE and proactive safety surveillance among its priorities for supporting data-driven innovation and earlier access to healthcare products.

Following each submission cycle, brief, non-confidential summaries of workshop discussions will be published, with the possibility of additional peer-reviewed publications involving participants. These outputs are intended to support transparency and shared learning on methodological approaches to RWE generation and assessment.