GovWire

Overview

The Innovative Licensing and Access Pathway (ILAP) aims to accelerate the time to market, facilitating patient access to medicines. These medicines include new chemical entities, biological medicines, new indications and repurposed medicines.

The ILAP is open to both commercial and non-commercial developers of medicines (UK based and or global). It comprises an Innovation Passport designation, a target development profile (TDP) and provides applicants with access to a toolkit to support the design, development and approvals process.

The ILAP provides you with opportunities for enhanced regulatory and other stakeholder input.

Partners

The permanent partners in the ILAP are:

• 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)

Supporting partners include:

• NHS England and NHS Improvement
• Health Research Authority (HRA)
• National Institute for Health Research (NIHR)

Eligibility through the Innovation Passport

The first step in the ILAP is the Innovation Passport application. This is the mandated entry point to the ILAP and is open to developers at the pre-clinical trial stage through to the mid-development programme point.

The passport includes a broad and inclusive definition of innovation and both new and repurposed medicines are in scope. This designation is linked to a portfolio of activities through the creation of a product-specific target development profile.

The evidence required for a product to fulfil the criteria will depend on where in the development pathway the product is and can be based on non-clinical data.

The Innovation Passport does not replace the promising innovative medicine (PIM) designation of the EAMS and you can apply for both initiatives.

You must submit an Innovation Passport application for each separate medicinal product (different active substances) and each separate indication.

The criteria for the passport are listed below, with the types of expected data.

Criteria 1: details of the condition, patient or public health area

• the condition is life-threatening or seriously debilitating
• there is a significant patient or public health need

This is not necessarily linked to the product as it sets out the grounds for the need to develop a medicinal product in a particular area.

If you are applying under the first characteristic, you should provide a summary of the condition and the life threatening or seriously debilitating nature including symptoms, lifespan and quality of life aspects and current treatment landscape.

If your submission is for significant patient or public health need, you must provide clearly defined evidence of a specific need (for example, a need for paediatric formulation, anti-microbial resistance), putting the need into the context of the current patient or public health setting. This evidence is likely to be generated from information in the public domain and/or patient engagement activities. For a justification of significant, you should discuss the magnitude of the issue(s) in a problem statement along with the identified gaps that remain in the current treatment landscape.

Criteria 2: the medicinal product fulfils one or more of a specific area (indicate which are applicable in your application).

The areas are:

a) innovative medicine such as an advanced therapy medicinal product (ATMP) or new chemical or biological entity or novel drug device combination

b) medicines being developed in a clinically significant new indication for an approved medicine

c) medicines for rare disease and/or other special populations such as neonates and children, elderly and pregnant women

d) development aligning with the objectives for UK public health priorities such as the Chief Medical Officer, Department of Health and Social Care (DHSC) or Life Sciences Sector Deal (including those in devolved administrations where appropriate)

For this criterion the applicant should to indicate which area(s) the product belongs to.

Depending on the area, you must provide the following evidence:

a) a full regulatory description of the product so that the product status can be determined (for example, name of drug substance, pharmaceutical form, route of administration, mechanism of action)

b) a description of the new indication in the context of the patient group, including the novelty of the proposal

c) a description of the use of the medicine in a particular special population

d) a description of where and how the product will fulfil public health priorities

Criteria 3: the medicinal product has the potential to offer benefits to patients

You must provide a summary of how patients are likely to benefit from the product or indication coming to market, including proposed improved efficacy or safety, contribution to patient care or quality of life, as compared to alternative therapeutic options. This should be based on evidence from the applicant with the product.

The claims can be supported either by data from valid non-clinical models of the condition or if justified extrapolated from another relevant model.

Depending on the stage of development of the product any available clinical data in a relevant population of patients can be provided. We strongly encourage applicants to include the views from patients or patient organisations around the benefits of a product in their evidence, if available.

Apply for an Innovation Passport

Applicants who wish to apply for an Innovation Passport should complete the submission form below. Your application will be reviewed by the MHRA ILAP team.

Following the review of your application, the partners (AWTTC, MHRA, NICE and SMC) will jointly consider if the criteria have been fulfilled and will inform you of the outcome.

To apply, fill in the Innovation Passport application form which is now prepared and submitted in a new part of the MHRA Submissions Portal. If you are a first-time user you will need to register to make your submission. Further guidance is available

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