Highlights
- ILAP as it currently stands
- What is the Innovation Passport?
- What stage of development does ILAP support?
- What is the Target Development Profile?
- How to access the TDP
- What is included in the TDP toolkit?
- How much does ILAP cost?
- What are the benefits of ILAP?
The Innovative Licensing and Access Pathway pathway is available to global commercial and non-commercial medicine developers. ILAP supports organisations developing new chemical substances and biologics, and new indications. ILAP allows companies to bring innovative medicines to UK patients faster by combining early regulatory input, structured development, and accelerated access.
In 2025, ILAP was relaunched with new eligibility criteria, simplified application steps, and an increased focus on ATMPs, rare diseases and high unmet medical needs.
This article explains what ILAP is, who qualifies, how to apply for an Innovation Passport, and how to build your Target Development Profile (TDP).
Whether you're an SME sponsor, regulatory strategist or biotech CEO, understanding ILAP's new framework is essential for successful MHRA engagement.
There are unique aspects to ILAP, comprised of:
- An innovation passport
- A target development profile (TDP), and
- Access to a toolkit to support the applicant in different aspects throughout the pathway.
Which organisations are involved in ILAP?
The ILAP pathway is collaborative in nature, whereby applicants are offered support and guidance from prominent stakeholders and partners, including1
- The All Wales Therapeutics and Toxicology Centre
- The Medicines and Healthcare products Regulatory Agency (MHRA)
- National Institute for Health and Care Excellence (NICE)
- Scottish Medicines Consortium (SMC)
Other organisations are supporting partners, including:1
- NHS England and NHS Improvement
- Health Research Authority (HRA)
- National Institute for Health Research (NIHR)
What is the Innovation Passport?
The first step in the ILAP pathway is to apply for an Innovation Passport, which must be submitted individually for each separate medicinal product, active substance and indication.
NOTE: the eligibility criteria will change in 2025 as a result of the MHRA relaunching ILAP.
Currently, to obtain an Innovation Passport, a medicine must fulfil several criteria (see Table 1).
Innovation Passport applications will be reviewed by the MHRA and ILAP partners (NICE, AWTTC and SMC).
What stage of development does ILAP support?
NOTE: the stage of clinical development when applying for ILAP will change in 2025 as a result of the MHRA relaunching ILAP.
Since its inception in 2021, ILAP has been open to applicants at various stages of clinical development and, thus far, has been dependent on the data available at the time of application; the desire for applicants to engage with UK stakeholders and the scope of the application.
Feedback from stakeholders highlighted the concern that the liberal entry criteria led to process unsustainability. Therefore, the relaunch of ILAP will focus on medicinal products that haven’t yet reached the pivotal clinical trial stage to better support medicine developers within the ILAP pathway at early-stage development.
What is the Target Development Profile?
The TDP is a nod to the target product profile and is generated by a team of experts based on an applicant’s product characteristics. The overarching purpose of the TDP is to create a bespoke roadmap for the applicant to develop a medicinal product for early patient access. Key themes of the TDP are:
The TDP is designed as a ‘living document’, updated as the programme develops, and new knowledge is gained. This may result in multiple TDPs being generated to account for new data collection, particularly for applicants who apply for ILAP at very early clinical development stages.
How to access the TDP
The TDP is accessible only through the Innovation Passport designation. The TDP meeting should occur shortly after the positive Innovation Passport decision or as specified in the approval letter. The applicant must complete the TDP submission form. The applicant will then meet with MHRA and partners to discuss the TDP content, challenges, and tools. A TDP roadmap will be developed and sent to the applicant after the meeting.
What is included in the TDP toolkit?
The TDP toolkit is not a requirement. However, the applicant can choose from a collection of activities and assessments, offering support throughout the ILAP pathway.3
Clinical Practice Research Datalink (CPRD) Assisted Patient Recruitment
This is a service in the toolkit that can be used to locate patients in the UK who may be eligible to enter a clinical trial via the CRPD electronic health records (EHS) database.
Innovative licensing routes
These are routes to accelerate review timelines. Such routes include accelerated assessment, rolling review, conditional marketing approval, exceptional circumstances approval, Project Orbis and the Access Consortium.
ILAP Access Forum
This is a tool to help applicants understand approaches to market access that will streamline the road to patient access and offer a joint view of market access from ILAP’s stakeholders.
It is overseen by the UK’s health technology authority: NICE Office for Market Access (OMA), in conjunction with the Scottish Medicines Consortium (SMC) and All Wales Therapeutics and Toxicology Centre (AWTTC).
How much does ILAP cost?
Innovation Passport fee: £3,6241
Initial Target Development Profile (TDP) fee: £4,4511
What are the benefits of ILAP?
- Fast track to approval in the UK for innovative medicinal products.
- Extra regulatory support and guidance throughout clinical development.
- Joint guidance from ILAP partners including market access.
- A unique roadmap to develop a medicinal product for early patient access.
Summary
The Innovative Licensing and Access Pathway allows medicine developers to fast-track regulatory approval and patient access to innovative treatments. Developers submit an Innovation Passport to begin the process, which identifies the product as having high potential. The developers then create a Target Development Profile (TDP), outlining key development milestones and strategies. MHRA and stakeholders work with the developer to refine the TDP, ensuring efficient evidence generation and regulatory progress.
NOTE: Applications to the current version of ILAP ended on the 20th of November 2024. Application to the relaunch of ILAP can be submitted from March 2025.2 The MHRA will publish full details on the new pathway in January 2025.2
How Somerville Development Partners can help
We can advise you on how to approach and apply for ILAP. This will enable you to get the greatest return on your resources and have the greatest likelihood of being accepted into the ILAP pathway.
