In 2025, the MHRA conducted a Real-World Evidence Scientific Dialogue 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.
Following the pilot the MHRA is continuing with RWE Scientific Dialogue through ongoing workshops that enable open discussion on RWE topics whilst continuing to exploring the integration of RWE advice into existing MHRA services. This supports the MHRA’s Data Strategy ambition to promote data-driven innovation and early access to innovative products through RWE and proactive approaches to safety surveillance.
Approximate application window and workshops dates have been added for each MHRA-NICE RWE Scientific Dialogue cycle.
The application window for the first submission cycle of MHRA-NICE RWE Scientific Dialogue has now closed. The Expression of Interest Guidance for MHRA-NICE Real-World Evidence Scientific Dialogue page has been removed.
The MHRA Real-World Evidence Scientific Dialogue Programme pilot website has been updated to reflect the relaunch of the service and improvements informed by the pilot phase.
Key updates include:
-Updated description of the service offer, providing clearer information on the scope, purpose and eligibility of the updated MHRA-NICE Real-World Evidence Scientific Dialogue (RWE SD)
-Revised expression of interest process, setting out how applicants can apply to the RWE SD and what to expect at each stage
-Improved guidance for applicants, including clearer expectations on the type of questions suitable for discussion
-General content refresh, including updated language, structure, and accessibility improvements to support ease of use
These changes support the transition from a pilot to an established service and aim to provide greater clarity and consistency for stakeholders engaging with the programme.
Added update notifying that the pilot phase of the MHRA Real-World Evidence Scientific Dialogue Programme has now concluded
Updated to add text notifying the pilot phase of the MHRA Real-World Evidence Scientific Dialogue Programme has now concluded
Change to wording in section 5 and new link to updated form and guidance in section 5.
Changed to add download link to Expression of Interest for the MHRA Real-World Evidence Scientific Dialogue Programme pilot
Excerpt from the official page. The original is authoritative.