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MHRA updates ILAP guidance on route to faster UK access for transformative medicines

🇬🇧 MHRA · Mon 09 Nov 2026

The regulator has refreshed its Innovative Licensing and Access Pathway page, which joins developers, regulators, HTA bodies and the NHS in one route, but the source does not say what changed.

The Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance page on the Innovative Licensing and Access Pathway (ILAP) on 9 November 2026. The page was first published on 30 January 2025. The extract provided does not say what was changed in the latest revision.

ILAP is designed to bring the most transformative new medicines and drug-device combinations to patients in the UK health system more quickly. The page describes a single integrated platform for ongoing collaboration between the developer, the MHRA, UK health technology assessment (HTA) bodies, the NHS and patients. It states that the pathway is open for Innovation Passport applications.

The Innovation Passport is the mandatory entry point. Products that meet all eligibility criteria and best meet the selection criteria will be awarded one. The developer then works with a team of specialists from the ILAP partners to draw up a Target Development Profile (TDP). The TDP is meant to align and coordinate evidence generation and evaluation, flag implementation and service-delivery issues, and set out a roadmap for early patient access. The MHRA expects it to be a living document, updated as development milestones are reached and new knowledge emerges.

ILAP is open to commercial and non-commercial developers, UK-based or global. Eligible products must have a therapeutic aim and evidence of safe use in humans, but confirmatory trials must not yet have started. Support on offer includes priority access to regulatory and HTA services, early interaction with the NHS and patients, more predictable timelines and a dedicated point of contact. The pathway is delivered by AWTTC, Department of Health Northern Ireland, the MHRA, NICE, NHS England and the Scottish Medicines Consortium, with several further bodies as supporting partners.

The guidance page links to application guidance, a description of what the pathway offers, webinar and video recordings, data protection and privacy information, performance metrics, an Innovation Passport application form and an Innovation Passport list.

What it means for your team

  • Teams with innovative products still before confirmatory trials should check the updated eligibility and selection criteria in the ILAP application guidance.
  • The Innovation Passport is mandatory for entry, so early planning of the application is part of any UK access strategy using ILAP.
  • Market-access and regulatory colleagues should consider how a Target Development Profile would align evidence plans across the MHRA, HTA bodies and the NHS.
  • The source does not specify what changed, so teams should compare the current documents with earlier versions they hold.

Official source: MHRA ↗

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

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