As set out in our previous post, the Innovative Licensing and Access Pathway (ILAP) is an initiative aimed at bringing innovative medicines to the UK market more quickly. On 30 January 2025, the MHRA launched a new version of ILAP in response to feedback from stakeholders.

The first version was launched in January 2021, shortly after the end of the Brexit transition period. It enabled developers to work collaboratively with the NHS, MHRA, and UK Health Technology Assessment (HTA) bodies to bring their product to the UK market in a more streamline and efficient way, benefiting from tailored guidance and support as well as shorter timelines. The scheme saw high levels of applicants, but also faced criticism from stakeholders for a lack of clarity, overly permissive entry criteria and a lack of direct NHS involvement.

The new ILAP is designed to build on the previous model by ensuring:

• Improved dialogue between the ILAP partner organisations and the developers, which will now include the NHS as a core partner.
• A simpler roadmap with more predictable timelines. In particular, MHRA has sought to ensure that the initial step for Innovation Passport holders, known as the Target Development Profile (TDP), will provide increased clarity to help developers entering ILAP navigate the pathway.
• Enhanced eligibility and selection criteria, requiring developers to meet seven eligibility criteria, and if they meet those criteria, they will then be assessed against three selection criteria.

Eligibility Criteria

Applicants must meet all of the eligibility criteria to proceed to the selection stage of the process.

1. The product must be a medicine or drug-device combination product with a therapeutic aim. This is a notable expansion from the previous model, which was limited to medicines.
2. The product must not be an immunisation for the prevention of infection and/or disease, thereby excluding vaccines for prophylactic purposes from the scheme.
3. The applicant must be a legal entity with the rights to market the product in the UK.
4. The proposed product or innovation must be at the stage of clinical development where the human safety pharmacology has been preliminarily characterised and there is evidence of safe use in humans and confirmatory trials have not yet started.
5. There must be an intention to obtain regulatory authorisation to market the health product in the UK and a commitment to meeting HTA bodies’ evidential standards to demonstrate cost-effectiveness.  
6. The applicant must commit to working with the ILAP partners to create a TDP. 
7. The applicant must demonstrate commitment to conducting feasibility for opening one or more clinical trial sites in the UK for the product on the ILAP.

Selection Criteria

If an applicant meets all of the eligibility criteria, they will then be assessed against three selection criteria. Successful candidates will need to show “compelling evidence” that their product meets all three of the criteria. The assessment is made by all of the ILAP partners; input will also be sought from lay person representatives.

1. The specific indication is life-threatening and/or seriously debilitating and there is a significant unmet clinical need.
2. The product is innovative; meaning that the product must either be:
   • novel, such that no other product exists in clinical practice that uses the same mechanism of action e.g. a first in class molecule, a new chemical or biological entity, a novel drug device combination, new or a novel modification of existing technologies; or
   • it is an approved medicine being developed in a clinically significant new indication.
3. The product has the potential to offer a step change in management of the indication; meaning that the product must meet one or more of the following criteria:
   • demonstrates the potential to substantially improve patient health outcomes;  
   • offers the potential of a cure where none currently exists;
   • has the potential to substantially reduce care-related costs without negatively impacting the outcomes of patients.

Applications under the new ILAP

The new ILAP registration portal and application form will be available on the 31 March 2025. The application and assessment process will operate in quarterly cycles: