The Medicines and Healthcare Products Regulatory Agency (MHRA) has released updated information on its Innovative Licensing and Access Pathway (ILAP) relaunch.
The updates include new information on:
- Eligibility criteria
- Selection criteria
- ILAP services
The relaunch of ILAP stems in part from feedback to the MHRA from stakeholders expressing a lack of clarity regarding what ILAP offered, liberal entry criteria leading to process unsustainability, and a lack of NHS involvement, which affected the practical application of ILAP.
Essentially, the scheme has shifted focus to utilise the collaboration between the MHRA, the UK Health Technology Assessment (HTA) bodies and the National Health Service (NHS) in a single integrated platform to bring new medicines to patients in the UK faster.1
The updated pathway will feature streamlined processes, selective entry criteria, and stronger collaboration with the NHS to address unmet needs. By focusing on early-stage clinical development, ILAP aims to reduce time to market while supporting developers with guidance and integrated access to regulatory and healthcare systems. This refreshed approach seeks to create a clearer pathway for innovative medicines.
Updated ILAP eligibility criteria
Updated ILAP eligibility criteria1
Updated ILAP selection criteria
- Indication is life-threatening and/or seriously debilitating and there is significant unmet need
The medicinal product will be assessed against the NHS standard of care for the chosen indication. Therefore, the applicant must demonstrate how the proposed indication will meet the life-threatening/seriously debilitating criteria despite the current NHS standard of care methods and show that the product will address a significant medical need or provide a major therapeutic advantage against existing treatments. 1
- The medicinal product is innovative.
The applicant must show that the product is novel, i.e. no existing product uses the same mechanism of action. Approved products may be eligible if they are being developed in clinically significant new indications. 1
- The medicinal product can offer a change in how the indication is managed.
The applicant must show evidence that the proposed product can potentially and substantially improve health outcomes; can potentially provide a cure where none currently exists or can potentially reduce care-related costs substantially without detrimental effects to patient outcomes. 1
The applicant must also summarise to Lay Members how their medicinal product meets the selection criteria.
What are the benefits and resources applicants will receive through ILAP?
Applicants accepted onto ILAP will have access to: 2
- The ILAP Joint Scientific Advice (JSA) with MHRA and HTA bodies.
- The ILAP Access Forum.
- Operational planning and preparedness support.
- Prioritised scheduling to gain access to services such as MHRA scientific advice, MHRA pre-submission meetings and the National Institute for Health and Care Excellence (NICE) advice.
NOTE: the first step for innovation passport holders is the TDP, which is a bespoke roadmap for applicants. It is designed as a ‘living document’, updated as the programme develops, and new knowledge is gained.
ILAP Access Forum
The ILAP Access Forum is a confidential, collaborative service offered exclusively to Innovation Passport holders, aimed at supporting early engagement with key UK system stakeholders (NICE, AWTTC, SMC, and NHS England) to address and navigate market access challenges.
Feedback from NICE and associated stakeholders can be implemented into a medicine developer's market access strategy and potential challenges are discussed in meetings with stakeholders. This gives medicine developers insights for market access planning with the right people in UK healthcare systems, including clinical, patient groups, HTA, and NHS experts.
Priority scheduling pass
The priority scheduling pass aims to give medicine developers timely interactions with ILAP partners at stages of development when they are most needed. The TDP will also recommend the services required at different time points throughout the product’s development, including MHRA/NICE scientific advice, MHRA pre-submission meetings, Clinical Practice Research Datalink and the National Institute for Health and Care Research (NIHR) study support. 2
Clinical trial support
Innovation passport holders can access England’s national research delivery resources through the NIHR Research Delivery Network (RDN). The aim is to reduce the time and resources needed to plan, set up and deliver trials in England. Access to the NIHR study support service across the RDN, provides support in study-wide planning, clinical advice, and research delivery. This includes help with site identification, study design, recruitment strategies, and resolving trial delivery issues. The RDN supports all NHS trusts in England and 56% of GP practices.2 Sponsors also get access to the Sponsor Engagement Tool to provide regular updates on trial progress.
Innovation Passport holders planning commercial clinical trials in the UK will gain access to the NIHR RDN's new Active National Delivery Service, launching in late 2025.2
Key benefits include: 2
- Centralised support via the NIHR RDN Agile Research Delivery Team, offering skilled, flexible staff across England to aid research delivery.
- Access to the NIHR’s patient engagement in clinical development service, ensuring trials are participant-friendly through direct engagement with patients, the public, and carers—aligning with regulatory and industry standards.
- Access to Commercial Research Delivery Centres (CRDCs), specialised facilities for later-phase trials in the life sciences sector.
- Guidance from NIHR RDN, assisting Innovation Passport holders in study development and meeting evidential requirements for regulatory and HTA processes.
Clinical Practice Research Datalink
ILAP products will receive priority access to services from the Clinical Practice Research Datalink (CPRD), the UK's leading real-world research service supporting public health studies and interventional research. CPRD collects pseudonymised primary care data from UK General Practices, linking it with other health-related data to create a representative, anonymous UK population health dataset. 2
How CPRD Supports Clinical Studies:
- Access to high-quality longitudinal data on 60 million patients, many with 20+ years of follow-up. 2
- Rapid patient recruitment for phase 3 trials via CPRD SPRINT (speedy patient recruitment into trials) using near real-time searches of UK-wide electronic health records.
- Real-world data services to support regulatory and HTA submissions, including:
- UK-wide epidemiological insights on patient cohorts.
- External control arms for single- and multi-arm trials, using retrospective/prospective data.
- Post-authorisation safety, efficacy, and utilisation data, leveraging high-quality primary and secondary care records.
Engaging with NHS partners
ILAP will support engagement with NHS partners (NHS England and NHS bodies in Scotland and Wales) from early clinical development to prepare for the potential integration of new medicines into UK patient care.
NHS Partner Support Includes:
- Guidance on NHS access routes.
- Facilitating clinical and commissioning engagement to identify adoption barriers.
- Developing a UK-wide adoption strategy for new treatments.
- Monitoring ILAP product uptake across the NHS to assess adoption variations.
The MHRA has published the full range of services offered in ILAP.
Summary
The ILAP relaunch aims to streamline regulatory processes, enhance NHS collaboration, and ensure the most impactful innovations gain support. By integrating MHRA, HTA bodies, and the NHS into a single platform, the pathway accelerates access to innovative medicines for UK patients. With improved eligibility criteria, priority regulatory support, and access to real-world data, ILAP aims to provides a clearer, more efficient route for medicine developers. These changes reinforce the UK’s commitment to fostering innovation while maintaining a strong focus on patient outcomes and healthcare sustainability in the UK.
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.
