MHRA updates ILAP data-sharing information and Innovation Passport list

What Changed

The Medicines and Healthcare products Regulatory Agency (MHRA) updated its Innovative Licensing and Access Pathway (ILAP) guidance collection on 9 November 2026. The revisions concern information about data sharing between programme partners and records tracking the pathway’s progress.

“What’s on offer in the ILAP” now includes information on how Innovation Passport holder data is shared across partners. The performance page received a quarterly update and performance metrics following round 5 awards. The separate Innovation Passport List was also updated.

Who Is Affected

ILAP serves developers of potentially transformative medicines and drug-device combination products. Its relevance to the medical-device sector therefore includes organisations developing combination products with a therapeutic aim.

The pathway is open to commercial and non-commercial developers based in the UK or internationally. Its stated scope includes products with evidence of safe use in humans for which confirmatory trials have not yet started.

Regulatory and Technical Implications

ILAP brings developers together with the MHRA, UK health technology assessment bodies, the National Health Service (NHS) and patients. It aims to accelerate patient access through coordinated support beginning in early clinical development.

An Innovation Passport application is the mandatory entry point. Products meeting all eligibility criteria and best meeting the selection criteria receive a passport. Developers then work with specialists from the ILAP partners to prepare a product-specific Target Development Profile (TDP).

The TDP is intended to align evidence generation and evaluation while identifying development challenges, implementation issues and service delivery considerations. The MHRA expects this roadmap to evolve as new knowledge emerges during development.

Manufacturer Actions

Drug-device combination developers considering an application should examine the eligibility and selection criteria. The MHRA strongly encourages this assessment before applying through the ILAP registration portal.

Innovation Passport holders can review the revised explanation of partner data sharing. Teams monitoring programme delivery can also consult the refreshed performance page and passport list. The 9 November change log does not state the revised numerical metrics or describe the detailed data-sharing arrangements.

Confirmed Dates

The ILAP guidance collection was first published on 30 January 2025. The latest revision covering data-sharing information, performance reporting following round 5 awards and the Innovation Passport list is dated 9 November 2026.

That change-log entry does not announce a new application deadline.

Official Source

The MHRA’s “Innovative Licensing and Access Pathway (ILAP)” collection on GOV.UK brings together application guidance, programme services, performance information and the Innovation Passport list.

Https://www.gov.uk/government/publications/innovative-licensing-and-access-pathway-ilap