MHRA-NICE Real-World Evidence Scientific Dialogue now accepting applications in England

In 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) conducted a Real-World Evidence Scientific Dialogue programme (RWE SDP) pilot to assess whether early, structured regulatory engagement could support improved evidence generation. The initiative was designed to foster collaboration between regulators and applicants and to support 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 in aligning stakeholders.

On May 20, 2026, the MHRA-NICE Real-World Evidence Scientific Dialogue pilot became an established service. The service aims to:

• Enable strategically focused discussions on real-world evidence through precompetitive “safe harbour” workshops that explore appropriate study designs, data sources, and analytical methods to support the generation of high-quality RWE;
• Clarify and promote consistency in regulatory and HTA expectations for RWE by consolidating and harmonizing core methodological principles and evidentiary standards, while addressing key decision points and common challenges relevant to both regulatory and HTA contexts;
• Increase transparency and shared learning across the healthcare ecosystem by translating workshop discussions into publicly shareable outputs, developed collaboratively with partners including the National Institute for Health and Care Excellence (NICE).

Four workshops will be held each year, organized across two application cycles, with two workshops scheduled per cycle. Selected applicants will be invited to a precompetitive workshop jointly convened by the MHRA and NICE. The MHRA will not charge fees for RWE Scientific Dialogue workshops.

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.

The MHRA welcomes expressions of interest for proposals with a specific focus on real-world evidence. The expressions of interest will be excluded where products are already undergoing GB/UK regulatory or HTA procedures, or are already in MHRA pathways such as IDAP or AI Airlock.

The current application window is open from May 20 to August 17, 2026. Outcome notifications are expected in the first week of October 2026, with workshops planned for November 2026.

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

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

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