UK’s MHRA and NICE formalize early RWE dialogue initiative following pilot

The MHRA and NICE have relaunched their joint Real-World Evidence Scientific Dialogue initiative following a 2025 pilot, introducing updated guidance, revised application processes, and an expanded scope that now includes medical devices alongside medicines.

The Baseline

• The UK’s regulatory and HTA bodies have relaunched their joint RWE Scientific Dialogue initiative following a 2025 pilot that explored how earlier regulatory engagement could support evidence generation.
• The updated program offered by the MHRA and NICE aims to support earlier discussions on study design, data sources, and analytical methods while promoting greater consistency between regulatory and HTA expectations for RWE.
• The program forms part of the MHRA’s broader Data Strategy ambitions to support data-driven innovation, earlier access to innovative products, and proactive approaches to safety surveillance through the use of RWE.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) have expanded and formalized their joint Real-World Evidence (RWE) Scientific Dialogue initiative following a pilot program designed to assess whether earlier, structured engagement could improve evidence generation for both regulatory and health technology assessment (HTA) decision-making.

The pilot program was launched in early 2025 to explore how early dialogue between regulators and applicants could support the development of more robust RWE strategies. Four applicants participated in confidential meetings with the MHRA alongside a precompetitive “safe harbor” workshop jointly convened with NICE. Discussions covered product-specific and commercially sensitive RWE topics across multiple disease areas and stages of the product lifecycle, while the workshop focused on the opportunities and challenges associated with using real-world data (RWD) in rare diseases.

According to the agencies, the pilot demonstrated the value of early dialogue, highlighted the need for clearer regulatory expectations, and showed the benefits of workshop-based engagement for improving stakeholder alignment around evidence generation approaches.

Following the pilot, the MHRA and NICE have relaunched the program as an ongoing service with revised guidance, updated application procedures, and broader eligibility criteria. The initiative will now also accept applications involving medical devices, with Approved Bodies – organizations designated to assess whether medical devices meet UK regulatory requirements for safety, quality, and performance – participating in relevant workshops.

The updated program is intended to support strategically focused discussions on RWE in a precompetitive setting, enabling participants to explore study designs, data sources, and analytical methodologies relevant to high-quality evidence generation. The agencies also stated that the initiative aims to promote greater consistency between regulatory and HTA expectations for RWE by addressing shared methodological challenges, key evidentiary questions, and common decision-making considerations. Additional objectives include increasing transparency and shared learning across the ecosystem through publicly shareable outputs and potential peer-reviewed publications developed collaboratively with participants and partners including NICE.

Under the revised structure, four workshops will be held annually across two application cycles, with up to two applications selected per cycle. Workshops will provide a precompetitive setting for discussions around study design, data sources, and analytical methodologies relevant to RWE generation for regulatory and HTA purposes. Optional follow-up meetings may also be offered.

Priority will be given to proposals addressing cross-cutting methodological challenges, supporting shared learning, and exploring approaches relevant across regulatory, HTA, and NHS decision-making contexts. Applications linked to ongoing regulatory or HTA procedures, or already within established MHRA innovation pathways, such Innovative Licensing and Access Pathway (ILAP), will not be eligible.

The current application cycle opened on May 20, 2026 and closes on August 17, 2026, with selected workshops expected to take place in November 2026.