The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated application guidance for the Innovative Licensing and Access Pathway (ILAP), confirming how developers can apply to the refreshed pathway after its relaunch.
The update, published on 19 May 2026, follows MHRA’s January 2025 relaunch of ILAP after a review of the original scheme. The first version, introduced in 2021, gave developers an Innovation Passport and access to coordinated regulatory and access support. The refreshed model narrows entry, places more weight on early development timing and gives the Target Development Profile a more explicit role in aligning regulatory, HTA and NHS access issues.
ILAP is now open to commercial and non-commercial developers of medicines and therapeutic drug-device combinations. Products must have evidence of safe use in humans, but confirmatory trials must not yet have started. This places the pathway earlier in development, where advice can still affect trial design, evidence generation and market-access planning.
Applicants must also intend to market the product in the UK and commit to meeting UK health technology assessment evidential standards for cost-effectiveness. Successful applicants receive an Innovation Passport and then work with ILAP partners to develop a product-specific Target Development Profile, setting out regulatory and access touchpoints across development.
The updated guidance also clarifies the scope of products eligible for ILAP. It includes novel products, new chemical or biological entities, products using novel modifications of existing technologies and approved medicines in clinically significant new indications. Prophylactic vaccines and products with only a diagnostic aim sit outside the pathway.
Applications now run through defined cycles. The current round opened on 28 April 2026 and closes on 30 July 2026, with outcomes expected by 23 October 2026.
The update does not create a new reimbursement route. It does, however, confirms that the refreshed ILAP is now operating as a more selective pre-market access pathway, with earlier joint scrutiny of regulatory, HTA and NHS adoption requirements.
Source: Medicines and Healthcare products Regulatory Agency
Link: ILAP application guidance
Date: 19 May 2026
