MHRA-UK – The Innovative Licensing and Access Pathway (ILAP)

What is the UK ILAP?

The ILAP is a program designed to facilitate and accelerate the development of innovative medicines and drug-device combinations. The ILAP offers enhanced input from the stakeholders, with access to a single integrated platform for advice. This allows improved coordination across regulators (MHRA), Health Technology Assessment (HTA) bodies, and the National Health Service (NHS), and provides developers with clear guidance earlier in development. The aim is to reduce the time to patient access for transformative medicines, especially where there is significant unmet need.

Eligibility

The applicant must be a legal entity with the rights, and the intention, to market the product in the UK.  This includes, but is not limited to, private companies, public limited companies, limited liability partnerships, community interest companies, sole traders, higher education institutions, NHS organisations and charities. However, it is not a requirement for the applicant to have a legal entity registered in the UK.

The ILAP is open to products at the stage of clinical development where the human safety pharmacology has been preliminarily characterised and there is evidence of safe use in humans and confirmatory trials have not yet started. However, the product must not be an immunisation for the prevention of infection and/or disease. 

The Medicinal product in development must respond to all three criteria:

• An unmet need in a life‑threatening or seriously debilitating condition,
• Innovative medicine,
• Potential to offer benefit to patients.

Details on the ILAP process

ILAP comprises three core elements – fees apply throughout the process:

• first, the Innovation Passport as the mandatory entry point;
• second, the Target Development Profile, or TDP;
• third, a practical “toolkit” that brings enhanced opportunities for regulatory and stakeholder input.

The Innovation Passport Designation is the entry point of the process. One application should be submitted per medicinal product and per specified indication. The application and assessment process operates in quarterly cycles: application windows are opened for 3 months, with outcomes sent about 3 months later.

At that stage, Innovation Passport holders must commit to collaborating with the ILAP Partners to create a TDP within six months after receiving an Innovation Passport. A dedicated point of contact will be appointed to coordinate all ILAP support provided.

The TDP will help define key regulatory and development features, flag potential pitfalls, and create a roadmap for the product’s development. this roadmap will be a living document, updated along the development program timelines and milestones as new data are generated. The TDP will be used to determine which ILAP services are considered important for the advancement of the product through to regulatory approval and patient access.

The practical aspects of the toolkit will be discussed, based on the ILAP services identified by the TDP. The services are intended to drive efficiencies in the product’s development program, supporting data generation, evidence requirements and market access. Innovation Passport holders will receive prioritised access to these services after receiving their TDP.

Examples of Toolkit services:

• Compliance readiness inspections
• Certifications (“regulatory readiness for MAA”)
• Continuous benefit risk assessment integrating real world evidence
• Clinical Practice Research Datalink (CPRD) Assisted Patient Recruitment
• Enhanced patient engagement
• Innovative and Flexible Licensing Routes (accelerated access, rolling review etc.)
• Novel methodology and innovative clinical trial design
• Optimising market access approach (ILAP Health Technology Assessment Access Tool)
• Rapid Clinical Trial Dossier Pre-Assessment

Fees (correct fees in May 2026)

MHRA:

Innovation Passport: £3,945

Initial TDP: £4,845

Toolkit: Measure-dependent; confirmed during TDP process

NICE:

Contributions provided via Office for Market Access; NICE Scientific Advice and existing fee structures apply

Fees from other partner organisations may also apply.

How Boyds can help

At Boyds, our consultants bring extensive experience across a wide range of therapeutic areas and all stages of development, with particular expertise in advanced and novel therapies.

We can offer strategic advice about the suitability and timing of the ILAP application. We can contribute to the creation of necessary documents (application forms, briefing documents, regulatory documents…) at all stages of the process, and manage communications with the ILAP Partners. We can guide you through each procedure, and help prepare for scheduled advice meetings. Our support will help you to decisively address the challenges faced during product development and maximize the output received from the ILAP Partners.