MHRA’s ILAP Revamp: Accelerating Innovative Medicines in The UK

The MHRA is re-launching the Innovative Licensing and Access Pathway (ILAP). While the concept remains the same, they have introduced some updates. In this article, we will review the new ILAP and highlight the updates and their benefits for developers.

What Is ILAP? Breaking Down MHRA’s Fast-Track Approval System

The ILAP aims to accelerate the time for transformative new drugs and drug-device combinations to get to patients in the UK. It will do this by providing applicants with coordinated advice from all the various partners involved. It is a pathway where applicants will receive non-binding advice and support regarding:

• Their clinical development and trial delivery,
• The regulatory and procedural services available,
• The Health Technology Assessment (HTA),
• Market access, and
• The adoption by the National Health Services (NHS).

ILAP is accessible to UK and global developers (academic and commercial). The products in scope are novel drug-device combinations with a therapeutic aim and innovative medicines (e.g. first-in-class molecules, new chemical or biological entities, products which feature new technology or a novel modification of an existing one, and approved medicines being developed in a clinically significant new indication). Drug-device combinations with a diagnostic aim and immunisations for the prevention of infection and disease are out of the ILAP scope. However, immunotherapies, such as cancer vaccines, can apply to ILAP.

ILAP Eligibility Criteria: Does Your Innovation Qualify for Accelerated UK Approval?

The first step of ILAP is the application for the Innovation Passport (IP). The selection criteria are:

1. The specific indication is life-threatening and/or seriously debilitating, and there is a significant unmet clinical need

2. The product is innovative: the product is either novel or is an approved medicine being developed in a clinically significant new indication

3. The product has the potential to offer a step change in the management of the indication:

• Clear and justified claimed benefits demonstrating the potential to substantially improve patient health outcomes and/or
• offers the potential of a cure where none currently exists and/or
• has the potential to substantially reduce care-related costs without negatively impacting the outcomes of patients.

Understanding the Innovation Passport (IP) Application Process

The IP application is assessed by the permanent ILAP partners (the MHRA, NICE, and the NHS and Lay Members. The NHS is represented by NHS England, All Wales Therapeutics and Toxicology Centre (AWTTC), and Scottish Medicines Consortium (SMC).

If the IP is awarded, the applicant meets with the permanent partners and collaboratively develop the Target Development Profile (TDP). The TDP will outline the critical regulatory and developmental aspects, identify the potential challenges, establish a roadmap that documents the services considered important and identify the key areas for future engagement. This roadmap is a living document and will be updated throughout the process.

IP holders will have exclusive access to the ILAP Joint Scientific Advice (JSA) from the permanent partners and to the ILAP Access Forum (Market Access support). They will also have priority access, i.e. access to the first available slot, for a number of services, which are otherwise accessible outside of ILAP. These are the MHRA Scientific Advice, the MHRA Pre-submission Meetings, the NICE Advice services, the Clinical Practice Research Datalink (CPRD), the SMC evaluation and potential eligibility for interim acceptance and the National Institute for Health and Care Research (NIHR) Study Support Service. Developers can also receive additional support from other government bodies if appropriate.

10 Key Updates to MHRA’s ILAP: What Developers Need to Know

1. Drug-device combinations with therapeutic aim are now eligible.

2. The IP criteria are stricter: the IP application cannot be based on nonclinical data anymore. Early clinical data, including early human safety, are necessary.

3. Products already in confirmatory studies are no longer eligible.

4. There is one ILAP per product and per indication, as opposed to the one ILAP per product previously.

5. There are defined timelines for IP applications, following quarterly cycles. The developer can apply at any time during these time windows.

6. The IP review meeting has been removed, and the IP assessment is based on the written application only.

7. IP holders also get a dedicated point of contact.

8. The applicant must commit to meet with the partners within 6 months after the award of an  IP, to establish the TDP.

9. The service offer to IP holders is clearer. It includes clinical development support with:

• Scientific Advice regarding the clinical development via the JSA (exclusively for IP holders), where regulatory and HTA advice can be provided
• Support for the clinical trial delivery via the NIHR Study Support Service
•  Access to the Active National Delivery Service via the NIH Research Delivery Network (RDN) (launched later in 2025)
• Prioritised access to Clinical Practice Research Datalink

The IP holders can also access exclusive market access support via the ILAP Access Forum (provided by NICE and the NHS representants), and support from the NHS for the Health System Adoption.

10. To facilitate the adoption of the new product in the health services, the NHS representants became permanent partners.

The Strategic Benefits of MHRA’s ILAP

Thanks to the early insights into regulatory, HTA, and NHS requirements, ILAP can help de-risk the development timeline. Multiple organisations can evaluate the data in parallel and share it. The early engagement with the partners ensures the alignment of the generated evidence with the MAA and HTA requirements. This promotes cost- and time-efficient development and smoother routes for routine access and system-wide adoption.

However, it is worth remembering that advice issued through ILAP is applicable only to the UK. Also, ILAP encourages developers to frontload the preparation of their clinical strategy to save time in the running of the clinical trials. However, if challenges unforeseen during the JSA arise and require protocol amendments, this may result in a longer timeline. Finally, the second version of ILAP will start on 31 March 2025, and the partners will keep reviewing the process. Therefore, there is a chance that new challenges will be identified in the first application cycles and new updates will arise.

ILAP does not replace MHRA Scientific Advice (SA) and Early Access to Medicines Scheme (EAMS). The key difference is that ILAP involves regulators, HTA bodies, the NHS, and additional stakeholders, whereas the other procedures only involve regulators. In SA, the topics covered are limited to quality, nonclinical, and clinical questions. EAMS is a UK scheme that aims to provide earlier availability of a promising unlicensed medicine to patients with a high unmet clinical need.

ILAP in 2025: Key Takeaways for Strategic UK Market Entry

In summary, ILAP is an end-to-end pathway that provides support and advice for developers of innovative medicines and drug-device combinations who want to market their products in the UK. It aims to collaborate with UK stakeholders to reduce the time spent on clinical development and patient access. Compared to the initial ILAP version, the service access criteria have become more selective. This will enable the ILAP partners to support the most innovative products from their early clinical development stage and work toward a pre-planned timeline, ensuring better planning for the developers.

Our experts at DLRC are here to discuss your needs and help you navigate the regulatory landscape. Contact us at hello@dlrcgroup.com to find out how we can support you.