UK MHRA GUidance: Innovative Licensing and Access Pathway (ILAP): Application Requirements and Support for Innovative Medicines
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on the Innovative Licensing and Access Pathway (ILAP), an initiative designed to accelerate patient access to transformative medicines through coordinated collaboration between developers, regulators, Health Technology Assessment (HTA) bodies, the NHS and patients.
The pathway provides early-stage development support, regulatory and scientific advice, clinical trial delivery assistance, market access guidance and health system preparedness. The updated guidance explains the eligibility requirements, application process and services available to Innovation Passport holders.
1. Overview of the ILAP
The ILAP provides a single integrated platform for sustained collaboration between medicine developers and key UK healthcare stakeholders. It aims to reduce unnecessary delays across medicine development, regulatory assessment, HTA and NHS adoption.
The pathway is open to UK-based and international commercial and non-commercial developers of potentially transformative medicines and eligible drug-device combination products.
The Innovation Passport is the mandatory entry point. Successful applicants work with ILAP partners to develop a product-specific Target Development Profile (TDP), which outlines the regulatory, clinical development and market access requirements.
2. Products Covered and Eligibility Requirements
The ILAP supports medicines at a stage where preliminary human safety pharmacology has been characterised, evidence of safe use in humans is available, and confirmatory trials have not yet started.
Products within scope include:
Novel medicines, including first-in-class products.
New chemical and biological entities.
Products incorporating new or modified technologies.
Approved medicines being developed for clinically significant new indications.
Novel drug-device combinations with a therapeutic aim, regulated under the Human Medicines Regulations 2012.
Preventive vaccines, diagnostic products and drug-device combinations with a diagnostic aim are outside the scope. Therapeutic vaccines intended to treat existing diseases, such as cancer immunotherapies, may be eligible.
Applicants must meet the following requirements:
Be a legal entity with rights to market the product in the UK. Both UK and non-UK applicants can apply.
Have an active clinical development programme with preliminary human safety data available.
Apply before confirmatory trials have started, subject to the specific provisions in the guidance.
Demonstrate an intention to seek UK marketing authorisation and meet UK HTA evidence requirements.
Commit to developing a Target Development Profile with ILAP partners.
Commit to conducting feasibility work for opening one or more UK clinical trial sites.
Hypothetical products or applications based solely on theoretical concepts or literature reviews without an actual product and active development programme are not eligible.
3. Innovation Passport Selection Criteria
Applications that meet the eligibility requirements are assessed against three selection criteria. ILAP partners and lay representatives participate in the assessment, with lay members having equal decision-making authority.
Criterion 1: Significant unmet clinical need
The indication must be life-threatening or seriously debilitating despite available NHS standard of care and address a significant unmet clinical need. Products for rare diseases are encouraged.
Criterion 2: Innovation
The product must demonstrate a meaningful level of innovation, such as a first-in-class mechanism of action, a new chemical or biological entity, a novel drug-device combination, a new technology or an approved medicine developed for a clinically significant new indication.
Criterion 3: Potential to deliver a step change
The product should demonstrate potential to improve patient outcomes substantially, offer a potential cure where none currently exists, or reduce healthcare costs without negatively affecting patient outcomes.
Applicants should support their claims using relevant mechanism-of-action information, preclinical and clinical data, modelling, epidemiology or other scientific evidence. The potential benefits should be compared with existing NHS treatment options.
4. Innovation Passport Application Process
Applicants are encouraged to review the eligibility and selection criteria before submitting an application.
The application process involves:
Complete the Innovation Passport application form.
Submit the completed form in PDF format through the ILAP registration portal.
The MHRA ILAP team conducts an initial eligibility review.
Eligible applications are assessed by the ILAP Application Review Panel, comprising ILAP partners and lay representatives.
Successful products demonstrating compelling evidence against all three selection criteria are awarded an Innovation Passport.
The application and assessment process operates in quarterly cycles, with each application round open for approximately three months.
Published application rounds:
Application window | Closing date | Outcome by |
4 August 2026 | 4 November 2026 | 4 February 2027 |
9 November 2026 | 11 February 2027 | 14 May 2027 |
18 February 2027 | 20 May 2027 | 20 August 2027 |
5. Target Development Profile (TDP)
After receiving an Innovation Passport, the developer is invited to collaborate with ILAP partners to create a product-specific Target Development Profile.
Innovation Passport holders must commit to developing the TDP within six months of receiving the passport.
The TDP provides a coordinated roadmap covering:
Critical regulatory and clinical development considerations.
Evidence generation and evaluation requirements.
Potential development challenges and opportunities.
HTA and market access requirements.
NHS implementation and service delivery considerations.
The TDP is intended to evolve throughout the product lifecycle as new evidence and development milestones emerge. Each holder is also assigned a dedicated point of contact to coordinate support and access to relevant ILAP services.
6. Support and Services Available to Innovation Passport Holders
The ILAP offers a range of services to support product development, regulatory assessment, market access and health system adoption.
Prioritised access to key services
Innovation Passport holders receive priority scheduling for selected services, including MHRA Scientific Advice Meetings, MHRA pre-submission meetings, NICE advice services, Clinical Practice Research Datalink (CPRD) services, Scottish Medicines Consortium evaluation and NIHR clinical study support. Priority scheduling is available for up to two MHRA Scientific Advice Meetings. Standard service fees continue to apply, with no additional charge for the priority scheduling pass.
ILAP Joint Scientific Advice (JSA)
This exclusive ILAP service provides coordinated scientific advice from the MHRA and UK HTA partners on evidence requirements for marketing authorisation and HTA.
Advice can cover clinical trial design, study populations, comparators, endpoints, patient-reported outcomes, real-world evidence generation and health economic plans.
The service does not design trial protocols or economic models, endorse developer proposals, discuss product pricing or provide an early product evaluation. Advice is non-binding and is intended to help developers prepare for future regulatory and HTA assessments.
Clinical trial delivery support
Through the NIHR Research Delivery Network, Innovation Passport holders can access support for UK clinical trial planning and delivery. This includes site identification, recruitment strategies, clinical advice, study feasibility and assistance in addressing trial delivery challenges.
The NIHR Study Support Service is available without fees.
Active National Delivery
The ILAP also describes the NIHR's Active National Delivery service for commercial clinical trials in the UK. The offer includes enhanced research delivery support, patient engagement services and access to commercial research delivery centres. The guidance states that the service is expected to launch in 2026, with commercial trials supported on a fee-for-service basis.
Clinical Practice Research Datalink (CPRD)
Innovation Passport holders receive prioritised access to CPRD services, supporting the use of real-world data throughout product development.
Available support includes longitudinal patient data, potential patient recruitment for clinical trials, real-world evidence generation, external control arms and post-authorisation safety, efficacy and utilisation data.
ILAP Access Forum
This exclusive service helps developers understand market access challenges through early engagement with stakeholders across England, Scotland and Wales.
Discussions may cover the product's position in clinical pathways, NHS service delivery requirements, commissioning, infrastructure, HTA routes and commercial processes. The forum provides non-binding feedback and is not part of formal HTA guidance processes.
Health system access and adoption
NHS partners provide a structured System Preparedness Offer to identify and address barriers to introducing innovative medicines into routine patient care.
Support includes early advice on the NHS access environment, clinical and commissioning expertise, diagnostics, infrastructure, workforce and capacity planning. Post-launch monitoring can also help assess medicine availability and uptake.
Engagement is coordinated across NHS England, NHS Scotland, NHS Wales and Health and Social Care Northern Ireland. The level and timing of support are agreed on a case-by-case basis.
7. Data Sharing and Confidentiality
Information submitted during the Innovation Passport application and TDP process is shared within the ILAP team and relevant partner organisations where necessary to support product development and access planning.
Confidentiality arrangements, institutional agreements and governance controls are applied to protect shared information. The framework also includes safeguards to maintain the integrity and impartiality of subsequent regulatory and HTA decisions.
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