What is ILAP?
The Innovative Licensing and Access Pathway (ILAP) was launched by the UK MHRA in January 2021 with the aim of accelerating the time to market for innovative medicines, thereby facilitating timely patient access. The aim was to provide applicants with access to a toolkit to support all stages of the design, development and approvals process. ILAP provided opportunities for enhanced regulatory agency and other stakeholder input into the development process, important for both medicine regulation and market access.
This first iteration of the ILAP was suspended in November 2024 as too many products had been assigned to the ILAP, with 166 innovation passports granted, and a more focussed approach was required to target the most potentially transformative medicinal products. ILAP was reformed according to the principles laid out in the government sponsored report ‘Pro-innovation Regulation of Technologies Review’ published in March 2023. This focussed on emerging digital technologies and noted that the regulation of such innovative products faced many challenges due to uncertainty of the application of existing regulatory frameworks across multiple relevant regulatory bodies. Stakeholder feedback also showed that the ILAP lacked clarity with insufficient NHS involvement to support timely adoption of ILAP products by the NHS.
ILAP relaunch
ILAP was relaunched in January 2025 for transformative new medicines and drug-device combinations that target unmet needs. The relaunched ILAP provides a system wide approach for product development and access to the UK market, allowing for early collaboration between the developer, the Medicines and Healthcare products Regulatory Agency (MHRA), the National Health Service (NHS) and the relevant Health Technology Assessment (HTA) bodies.
The permanent partners in the ILAP are:
- The Medicines and Healthcare products Regulatory Agency (MHRA)
- National Institute for Health and Care Excellence (NICE)
- The All Wales Therapeutics and Toxicology Centre (AWTTC) (on behalf of Health Boards and NHS Trusts in Wales)
- Scottish Medicines Consortium (SMC) (on behalf of NHS boards in Scotland)
- NHS England (previous to March 2025)
Supporting partners include:
- Department of Health and Social care (DHSC)
- Health Research Authority (HRA)
- National Institute for Health Research (NIHR)
- Office for Life Sciences (OLS)
- Department of Health Northern Ireland
ILAP is the only end-to-end access pathway in the world and should remove inefficiencies and costs associated with independent interactions with ILAP partners by the developer. Key improvements upon the 2021 iteration is the inclusion of drug-device combinations and the introduction of a simpler roadmap, allowing a more bespoke service, with more predictable timelines. The NHS are now core partners, which aims to ensure that the service is prepared for timely delivery of innovative products once regulatory approval is obtained. This shifts the focus of ILAP away from a regulatory toolbox for aiding development towards a UK market access pathway. However, since the January 2025 relaunch of ILAP, the new government has abolished the administrative body of the NHS in England, namely NHS England, which raises questions about the exact nature of interactions between the developer and the NHS within the ILAP in the near future.
ILAP is open to both UK based and non-UK based developers with rights to market the development product in the UK. Developers can apply following preliminary characterisation of human safety pharmacology, where there is evidence of safe use in humans, but before confirmatory clinical trials have commenced. There must be an intention from the ILAP applicant to obtain regulatory authorisation to market the product in the UK and a commitment to meeting UK HTA bodies’ evidential standards to demonstrate cost-effectiveness. There must also be a commitment to conducting feasibility studies for opening clinical trial sites in the UK.
The application process
The ILAP comprises a two-step process starting with an Innovation Passport (IP) designation, followed by definition and advancement of a Target Development Profile (TDP), which outlines a product’s critical regulatory and developmental aspects to provide a roadmap for regulatory approval and market access.
To be eligible for an IP, three criteria must be met:
- The condition is life-threatening, or seriously debilitating, and there is a significant unmet clinical need
- The product is innovative, either:
- A new chemical/biological entity
- A product which features new or a novel modification of an existing technology
- Repurposing of an existing product for a clinically significant new indication
- The product has potential to offer a step change in management of the indication
Applications for an IP can be made within a 3 month window using the ILAP registration portal and the outcome is given 3 months after the application window is closed. The current non-refundable fee for an IP application is £3,945, with a fee review in April each year.
Assuming IP designation is granted, a developer must commit to collaborating with the ILAP partners to create a TDP within 6 months after receiving the IP, with the aim to:
- Create a collaborative platform for the ILAP partners for a shared understanding of the product development
- Streamline, align and co-ordinate evidence generation and evaluation
- Identify key implementation and service delivery issues, with identification of risks associated with system wide requirements
The current non-refundable fee for the TDP is £4,845, with a yearly fee review in April. The TDP roadmap will indicate the tools that are considered important for the advancement of the product through to regulatory approval and patient access, and will identify key areas for engagement with relevant ILAP partners/stakeholders at key times within the development programme. The TDP is a living document that is updated as development progresses.
Once a TDP is established, all ILAP services can be accessed by the IP holders, which includes:
- Priority Scheduling Pass; Prioritises the product within ILAP partners work schedule and allows for prioritised MHRA Scientific Advice and pre-submission meetings, NICE Advice, SMC evaluation, and NIHR study support services.
- ILAP Joint Scientific Advice; Delivered by NICE and provides feedback on the evidence generation plan within the TDP from a regulatory and HTA perspective.
- NIHR Study Support Service; Access to the NIHR Research delivery network infrastructure, to speed up the set-up of clinical trials.
- Active National Delivery; This is offered by the NIHR when launched later in 2025, which aims to guide IP holders through study development by accessing the NIHR Patient Engagement in Clinical Development Service (to ensure robust studies) and the Commercial Research Delivery Centres (CRDCs) across the UK (bespoke facilities to deliver later phase trials for the life sciences industry).
- Clinical Practice Research Datalink; Access to the UK real-world research service that collects pseudonymised patient data from a network of General Practices across the UK and can provide an anonymous, longitudinal, representative UK population health dataset.
Developers of transformational innovative products are encouraged to apply as early as possible in the development process in order to achieve maximum benefit from access to these services. With early input from all key stakeholders, the ILAP aims to introduce efficiencies in order to minimise the time required for clinical trial set up and completion, MHRA and NICE approval and access to the NHS service for development products.
Any questions?
If you have any questions on this topic or want to reach out regarding any aspect of your own regulatory programme, please don’t hesitate to get in touch via email (info@s-cubed.co.uk), or by telephone (S‑cubed Ltd: +44 1235 77 22 60).
How can S-cubed help you?
Our Regulatory Affairs team have extensive regulatory expertise encompassing new chemical and biological entities, as well as medicinal products containing established active ingredients, generic compounds, and therapies for orphan indications. This includes recent and ongoing experience with the ILAP pathway. Why not get in touch to see how we can help?
Source: https://www.gov.uk/government/publications/innovative-licensing-and-access-pathway-ilap