RegulatoryGuideline · final

MHRA updates ILAP guidance as pathway stays open for Innovation Passport applications

🇬🇧 MHRA · Mon 09 Nov 2026

The UK regulator's Innovative Licensing and Access Pathway, which joins regulators, HTA bodies and the NHS, was updated on 9 November 2026 and continues to accept entry applications.

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

The page states that ILAP is open for Innovation Passport applications, the mandatory entry point to the pathway. Applicants are strongly encouraged to review the eligibility and selection criteria before applying through the ILAP registration portal. Products that meet all eligibility criteria and best meet the selection criteria will be awarded a passport.

ILAP is aimed at transformative medicines and drug-device combinations. It is open to commercial and non-commercial developers, UK-based or global, whose products have a therapeutic aim and evidence of safe use in humans but whose confirmatory trials have not yet started. The MHRA describes it as a single integrated platform for collaboration between the developer, the regulator, UK health technology assessment (HTA) bodies, the NHS and patients.

After a passport is awarded, the developer works with specialists from across the ILAP partners to build a Target Development Profile (TDP). This sets out regulatory and developmental aspects, potential challenges and a roadmap for early patient access. The MHRA expects the TDP to be a living document, updated as new knowledge is generated. A dedicated point of contact coordinates support.

Support on offer covers prioritised access to key services, clinical development, clinical trial delivery, market access and health system adoption. The partners are the All Wales Therapeutics and Toxicology Centre, Department of Health Northern Ireland, the MHRA, NICE, NHS England and the Scottish Medicines Consortium. Supporting partners include DHSC, the Health Research Authority, NIHR, the Office for Life Sciences, and the Scottish and Welsh Governments.

What it means for your team

  • Developers of potentially transformative products still in the pre-confirmatory-trial stage can apply for an Innovation Passport, the compulsory first step into ILAP.
  • Review the eligibility and selection criteria and the application guidance before submitting through the ILAP registration portal.
  • The TDP offers a way to align evidence generation across regulatory, HTA and NHS requirements, so market-access teams may wish to engage early.
  • The page's source text does not detail what the 9 November 2026 update changed, so teams should check the full guidance and the Performance Metrics and Innovation Passport list.

Official guideline text: MHRA ↗

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

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