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MHRA opens latest application cycle for MHRA-NICE real-world evidence scientific dialogue

🇬🇧 MHRA · Thu 05 Nov 2026

The regulator has added application details and an expression-of-interest form for the newest cycle of its RWE service, now running as an established offer after a pilot.

The MHRA updated its corporate report page on the MHRA-NICE Real-World Evidence Scientific Dialogue on 5 November 2026. The update adds application details for the latest submission cycle, a link to the expression of interest (EOI) form, and a new guidance document titled "How to complete an EOI for the MHRA-NICE Real-World Evidence Scientific Dialogue".

The service follows a pilot run in 2025 to test whether early, structured engagement with the regulator could improve evidence generation. The MHRA says the aim is to foster collaboration between regulators and applicants and support decision making for both regulatory and health technology assessment (HTA) purposes. The page records that the pilot phase had concluded by early 2026.

On 20 May 2026 the MHRA relaunched the service. It described a clearer scope, purpose and eligibility, a revised EOI process, and improved applicant guidance, including clearer expectations on which questions suit discussion. The first submission cycle's application window closed on 18 August 2026, and approximate window and workshop dates for each cycle were added on 4 September.

The MHRA says it is continuing the dialogue through ongoing workshops on RWE topics while still exploring how to build RWE advice into its existing services. It links the work to its Data Strategy ambition of promoting data-driven innovation, early access to innovative products through RWE, and proactive approaches to safety surveillance. The source does not set out the dates of the latest cycle or any new evidentiary requirements.

What it means for your team

  • Teams planning RWE generation, including post-authorisation studies, can now apply through the EOI route for the latest cycle; check the MHRA page for cycle timings and eligibility.
  • The new EOI guidance document should help applicants frame questions suitable for discussion; the MHRA says it has clarified expectations on question type.
  • The programme is open to both regulatory and HTA-relevant evidence questions, so market-access and regulatory teams may want to coordinate any submission.
  • The MHRA is still exploring how to fold RWE advice into existing services, so the format of this offer may change.

Official source: MHRA ↗

Article written by VigiEye from the official source (MHRA). AI-assisted; check the source before acting.

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