MHRA and NICE Advance Real-World Evidence Strategy

In an era where empirical truth must continually defend itself against populist obfuscation, the steady advance of evidence-based policymaking offers a vital corrective. The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the expansion of its Real-World Evidence (RWE) Scientific Dialogue, building upon a successful 2025 pilot programme. Jointly convened with the National Institute for Health and Care Excellence (NICE), this initiative represents a crucial step towards data-driven innovation and proactive health surveillance.

A Triumph for Evidence-Based Regulation

The 2025 pilot demonstrated the undeniable value of early, structured regulatory engagement. It brought together four applicants in confidential, product-specific meetings and a precompetitive 'safe harbour' workshop. This collaborative model facilitates robust decision-making for both regulatory approval and health technology assessment (HTA). Crucially, the pilot underscored the necessity of clearer regulatory expectations and proved that workshop-based engagement effectively aligns stakeholders across the healthcare ecosystem.

Expanding the Scope to Medical Devices

Moving forward, the MHRA-NICE RWE Scientific Dialogue will broaden its remit to accept applications concerning medical devices, with representation from Approved Bodies in relevant workshops. This expansion is a welcome development. It ensures that the rigorous standards applied to medicinal products extend to the devices upon which countless citizens rely, safeguarding patient rights and public health.

Prioritising Innovation and Vulnerable Communities

A truly progressive regulatory framework must serve the many, not merely the profitable few. To this end, priority will be given to proposals addressing cross-cutting RWE questions and supporting shared learning. The selection process will deliberately focus on ensuring diversity across disease areas, product types, and stages of authorisation. It will also scrutinise the variety of data sources, study designs, and analytical methods.

The pilot workshop's focus on the unique challenges of using Real-World Data (RWD) for rare diseases highlights a commitment to minority health outcomes. When regulators and innovators collaborate to overcome the evidentiary hurdles of rare conditions, they affirm the civic value that every patient deserves access to effective treatment, regardless of the commercial appeal of their illness.

Application Details and Transparency

The MHRA has confirmed that it will not charge fees for these RWE Scientific Dialogue workshops, removing a potential economic barrier to entry for innovators. Four workshops will be conducted each year, organised into two application cycles with two workshops per cycle. Up to two applications will be selected per cycle.

For the current cycle, expressions of interest will be accepted from 20 May 2026 until 11:59pm BST on 17 August 2026. The MHRA will notify applicants of the outcome in the first week of October, with the workshop hosted in November 2026.

Transparency remains a cornerstone of liberal governance. Following each cycle, brief non-confidential discussion summaries will be published, and participants will agree on the level of information disclosed in publicly shareable learning outputs. This commitment to open knowledge ensures that the insights generated benefit the wider ecosystem, rather than remaining locked behind corporate confidentiality.

Applications not selected may still seek advice through existing MHRA and NICE scientific advice services. The second submission cycle of 2026 is expected to launch in November. For inquiries or assistance with submissions, applicants are encouraged to contact