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The product must:
a. contain any substance or combination of substances presented as having properties of treating disease in human beings; or
b. contain any substance or combination of substances that may be used by or administered to human beings with a view to restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action.
The substance(s) within any drug-device combination (DDC) must have more than an ancillary effect and the DDC product must be regulated under The Human Medicines Regulation 2012 to be considered eligible for the ILAP.

Vaccine products that are intended for prophylactic purposes are not in scope for the ILAP (see vaccine definition in The Human Medicines Regulations Act 2012). Instead, these types of products are under the remit of the JCVI (Joint Committee on Vaccination and Immunisation). Any therapeutic vaccines intended to treat existing disease (e.g., cancer immunotherapies, often referred to as cancer vaccines) are eligible for the ILAP. 

The applicant must be a company, organisation or sole trader that has legal rights and responsibilities and has rights to the product or under product intellectual property rights, for developing, manufacturing, commercialising, marketing, promoting, distributing, selling, offering for sale, importing, or otherwise exploiting the Product in the UK. 

For the avoidance of doubt this includes, but is not limited to, private companies, public limited companies, limited liability partnerships, community interest companies, sole traders, higher education institutions, NHS organisations and charities (this list is not exhaustive).

Applications to the ILAP will be considered from both UK and non-UK applicants providing they are a legal entity with the legal rights to market their product in the UK. It is not a requirement for the applicant to have a legal entity registered in the UK.

Clinical trials must be underway with initial safety pharmacology data available, but clinical trials to confirm safety and efficacy to provide definitive evidence for a Marketing Authorisation Application (MAA) in the UK have not yet started. Products that have had their Clinical Trial Authorisation (CTA) approval, but initial safety data is not yet available will not be eligible. Where an unlicensed product has been administered to humans outside of clinical trials (for example, 'specials'), the safety data collected from these may be considered as evidence to support an application to the ILAP. In cases where the First in Human (FIH) clinical trial is intended to be the confirmatory trial, such as for rare diseases where a comprehensive MAA data package is particularly challenging to provide, the product may also be considered eligible for the ILAP. In this scenario, the initial safety data from the FIH must be available and submitted as part of the ILAP application.

Once clinical development has finished, there must be an intention to market the product on the UK market and commitment to meeting UK HTA bodies evidential standards.

When a product enters the ILAP, a meeting with a team of experts to develop a product specific Target Development Profile (TDP) will be arranged. The TDP will define regulatory and access touchpoints across the product development. This is a prerequisite for ongoing support and access to the service on offer via the ILAP.

Products that do not complete this step will be withdrawn from the pathway.

The UK Government is committed to supporting placement of clinical trials in the UK. Successful applicants will be expected to demonstrate commitment to conducting feasibility for opening one or more clinical trial sites in the UK for the product on the ILAP. Additional support will be on offer to facilitate site identification and feasibility.

Where this has not already been conducted, failure to undertake this may result in the product being withdrawn from the pathway.