Products in scope of the ILAP 

The ILAP is open to products 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. This is the stage of development in which the ILAP can offer the most benefit. Entry onto the ILAP will be for products that are considered to meet the ILAP eligibility and selection criteria based on the information provided by the developer. A separate ILAP application is required for each individual product and each specified indication.  There may however be limited exceptional circumstances where this is not necessary.    

The Innovation Passport does not replace the [promising innovative medicine (PIM) designation of the Early Access to Medicine Scheme (EAMS) or other accelerated access routes such as Project Orbis. Applications are permitted for other initiatives. 

Medicines in the scope of the ILAP include:  

• Novel products: no other product exists in clinical practice that uses the same mechanism of action such as a first in class molecule  
• New chemical or biological entities 
• Products which feature new or a novel modification of existing technologies 
• Approved medicines being developed in a clinically significant new indication 

Drug-device combinations in the scope of the ILAP include: 

• Novel drug-device combination products with a therapeutic aim, regulated under the Human Medicines Regulations 2012 

Medicines and drug-device combinations with a diagnostic aim, as well as immunisations for the prevention of infection or disease are not within the scope of the ILAP. 

Eligibility  

Applications will be considered from any commercial or non-commercial developer (UK based or global) that can fulfil all the following eligibility criteria: 

1. The product must be a medicine or drug-device combination product with a therapeutic aim.

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 (The Human Medicines Regulations 2012) to be considered eligible for the ILAP.

2. The product must not be an immunisation for the prevention of infection and/or disease. 

Vaccine products that are intended for prophylactic purposes are not in scope for the ILAP (e.g., 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.

3. The applicant must be a legal entity with the rights to market the product in the UK. 

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).

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.

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 Market 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 (e.g. ‘specials’, the safety data collected 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.

5. There must be an intention to obtain regulatory authorisation to market the health product in the UK and a commitment to meeting UK Health Technology Assessment (HTA) bodies’ evidential standards to demonstrate cost-effectiveness.  

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.

6. The applicant must commit to working with the ILAP partners to create a Target Development Profile (TDP). 

When a product enters the ILAP, a meeting with a team of cross partner 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. Developers with products in the ILAP will have their product withdrawn from the pathway if they do not commit to the creation of a TDP.

7. The applicant must commit to conducting feasibility to opening clinical trial sites in the UK. 

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.

Selection criteria  

Applications which meet the eligibility criteria will be assessed against the selection criteria by all the ILAP partners.  In addition, opinions will be sought from lay person representatives, known as Lay Members. This input will be used to inform the decision-making process. To facilitate this, applicants will be asked to include a plain English summary that clearly explains how their product meets the selection criteria. 

This assessment will be completed based on the information provided in the application form.   

The Innovation Passport will be awarded to products which are considered to demonstrate compelling evidence against all three of the selection criteria. 

The evidence provided in the application will be considered against the following selection criteria: 

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

The application must provide sufficient evidence to demonstrate the extent to which the indication impacts a patient’s life and represents a clinical unmet need. The product will be considered in the context of the available NHS standard of care treatment(s) for the specified indication. It should demonstrate that the product meets both of the following: 

• The indication is life threatening and/or seriously debilitating despite current NHS standard of care.   
• Must address a significant unmet clinical need, which means that there is no satisfactory method of prevention or treatment for the indication that has regulatory approval or, even if such a method exists, the medicinal product concerned will be of major therapeutic advantage to those affected.  

Products being developed for the treatment or management of rare diseases are encouraged.  

Alignment to health system priorities will be taken into consideration.   

Criterion 2: The product is innovative 

The application must provide sufficient evidence demonstrating the extent of the product’s level of innovation and impact, in the context of the current treatment paradigms, as well as the wider scientific and technological landscape. The application must provide evidence to demonstrate that the product meets one of the following: 

• It is novel. No other product exists in clinical practice that uses the same mechanism of action such as a first in class molecule, a new chemical or biological entity, a novel drug device combination, new or a novel modification of existing technologies.   
• It is an approved medicine being developed in a clinically significant new indication.   

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

The application should provide evidence to demonstrate the product’s potential to deliver benefits to patients and/or the wider healthcare system. Sufficient evidence must be provided to demonstrate that the product meets one or more of the following: 

• Clear and justified claimed benefits demonstrating 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.  

The claimed potential benefits and magnitude of impact should be contextualised against the existing NHS standard of care treatment(s) for the indication; therefore, it is essential to detail how the product offers improvements or advancements in comparison.  All claims made should be substantiated by robust, scientific reasoning and evidence. The evidence required for a product to meet the criterion will vary based on its stage in the development pathway and may include data generated during the product’s development or from the broader scientific literature. 

Apply for an Innovation Passport 

Applicants are strongly encouraged to review the eligibility and selection criteria and application form, prior to applying for an Innovation Passport.  

To apply, applicants will be required to complete the Innovation Passport application form and submit this through the ILAP registration portal. 

Please note the ILAP registration portal and application form will be available on the 31 March 2025. This page will be updated with a link to the portal on 31 March 2025. 

The application will be initially reviewed by the MHRA ILAP team to confirm eligibility. Following the eligibility review of the application, the ILAP partners (AWTTC, MHRA, NICE, NHS England and SMC) and Lay Members, will jointly consider the application. An Innovation Passport will be awarded to products which are considered to demonstrate compelling evidence against all three of the selection criteria.  

The ILAP application and assessment process operates in quarterly cycles. Each application round is open for three months, with new rounds of applications and assessment running concurrently over time.  Applicants will be informed of the outcome of their application by the end of the review period.  

Application window opens	Application closes	Outcomes by
31 March 2025 - 09:00 GMT	3 July 2025 - 17:00 GMT	3 October 2025
8 July 2025 - 09:00 GMT	7 October 2025 - 17:00 GMT	14 January 2026
10 October 2025 - 09:00 GMT	14 January 2026 - 17:00 GMT	17 April 2026
19 January 2026 - 09:00 GMT	21 April 2026 - 17:00 GMT	24 July 2026

Fees: Innovation Passport

Innovation Passport fee: £3,624  

Please note the Innovation Passport fee is not refundable if the application is not successful. 

Please note that the MHRA updates its fees on a regular basis. Changes to the MHRA’s fees will be implemented in April 2025 and therefore fees quoted may be subject to change.   

Data sharing and confidentiality 

Any information shared during the ILAP is considered as confidential. It will be held on a secure shared digital platform for access by the ILAP partners, as agreed by the applicant. In order to maximise the benefits of collaborative working with multiple UK stakeholders, the current and future sharing of relevant data is highly recommended. The partners will adhere to relevant institutional confidentiality and non-disclosure agreements. 

Contact

For further information on any of the specific services, please contact innovationpassport@mhra.gov.uk.