Medicines Healthcare Products Regulatory Agency
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.
Horizon scanning and regulatory science will make sure the pathway is at the forefront of cutting-edge developments and has the framework to develop evidence-based practice as new technologies and methods emerge.
The ILAP is open to both commercial and non-commercial developers of medicines (UK based and or global). It comprises of an Innovation Passport designation, a Target Development Profile (TDP) and provides applicants with access to a toolkit to support all stages of 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. The Innovation Passport 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 within 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.
In most cases you are expected to submit data around your lead indication and you must submit an Innovation Passport application for each separate medicinal product (different active substances). However, a single positive Innovation Passport can cover multiple indications for the same medicine (active substance) in the TDP.
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 will be expected to provide a summary of the condition and the life threatening or seriously debilitating nature including symptoms, life span and quality of life aspects and current treatment landscape.
Submissions for significant patient or public health need; you are required to 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, the magnitude of the issue(s) should be discussed 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 is expected 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 is expected so that the product status can be determined (e.g. name of drug substance, pharmaceutical form, route of administration, mechanism of action)
b) a description of the new indication should be provided 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 should be provided
d) a description of where and how the product will fulfil public health priorities should be provided
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. Applicants are strongly encouraged 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 that wish to apply for an Innovation Passport should complete the submission form below. You will then be invited to meet with the MHRA to discuss how your product fulfils the three criteria (usually within 4-6 weeks following receipt of the application form).
Following the meeting, the partners (AWTTC, MHRA, NICE and SMC) will jointly consider if the criteria have been fulfilled and you should be informed of the outcome within 4 weeks.
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 here, including a blank application form template so you know what is expected from you.