Innovative Licensing and Access Pathway

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 of an Innovation Passport designation, a Targettarget Developmentdevelopment Profileprofile (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. TheThis 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 withinin scope. This designation is linked to a portfolio of activities through the creation of a product-specific Targettarget Developmentdevelopment Profileprofile.

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 Promisingpromising Innovativeinnovative Medicinemedicine (PIM) Designationdesignation 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 willshould be expected to provide a summary of the condition and the life threatening or seriously debilitating nature including symptoms, lifelifespan span and quality of life aspects and current treatment landscape.

SubmissionsIf your submission is for significant patient or public health need;need, you aremust 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 andand/or or patient engagement activities. For a justification of ‘significant’, you should discuss 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 Devolveddevolved Administrations,administrations where appropriate)

For this criterion the applicant isshould 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.(for example, 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. ApplicantsWe are strongly encouragedencourage 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 thatwho wish to apply for an Innovation Passport should complete the submission form below. Your application will be reviewed by the MHRA ILAP Team.team.

Following the meeting,review of your application, the partners (AWTTC, MHRA, NICE and SMC) will jointly consider if the criteria have been fulfilled and youwill shouldinform beyou informed of the outcome within 4 weeks.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 here, including a blank application form template so you know what is expected from you.

Products in scope of the ILAP

Medicines in scope of the ILAP include new chemical entities, biological medicines, new indications and repurposed medicines.

Overview of Innovation Passport applications (25 March 2024)

• Total applications received (cumulative): 229

• 229.

  Numbers of Innovation Passports awarded: 115

115.

Applications received have included new and established medicinal products in both common and rare diseases in a variety of therapeutic areas (the top three areas of interest currently are oncology, neurology and respiratory). Applications have been received from a range of companies in the pharmaceutical industry, including small and mid-size enterprises.

When to enter the pathway

The ILAP enables multiple entry points depending on:

• the stage of development of the product
• the data available
• the ambition of the applicant to engage with UK stakeholders
• the applicant’s appetite for new innovative ways of working

Therefore, the pathway will allow entry very early, based on non-clinical data, where all the tools described below might be options, as well as catering for products with mid-development ‘global’ dossiers. However, to maximise the benefits, applicantswe areencourage encouragedapplicants to apply early in the development of their products. Products that are towards the end of their development programme are generally not suitable for the ILAP unless there are one or more indications still under active investigation.

The ILAP does not replace the Early Access to Medicines Scheme (EAMS), which remains an important flexibility for earlier patient access towards the end of the development programme in areas of unmet medical need and where major advantage over existing therapies can be demonstrated. The ILAP is broader in scope and is open to all innovative products.

Early pipeline discussions with developers are encouraged. These can be conducted with the MHRA and partners in the context of broader scope meetings, for example.

Find out more about how to get scientific advice from MHRA

Target Development Profile (TDP)

Mirroring the target product profile approach, a product-specific team of experts will help define the target development profile (TDP) based on your product’s characteristics. The TDP will define key regulatory and development features, identify potential pitfalls and create a road map for delivering early patient access.

The TDP will include details about how you can work with other UK stakeholders for coordinated and efficient evidence generation and evaluation and address commercial and managed access considerations. It is expected that the TDP is a living document, updated along the development programme timelines and milestones as new knowledge is generated. Therefore, for products that enter the ILAP at an early stage there may be multiple TDP versions as data are generated with the product.

The TDP Roadmaproadmap provides a pathway for facilitating a regulatory and access ready approach to medicines development. It will indicate the tools that are considered important for the advancement of the product through to regulatory approval and patient access and identify key areas for future engagement.

Accessing the TDP

The TDP can only be accessed through the Innovation Passport designation. The timing of the TDP meeting should be scheduled soon after the positive outcome from the Innovation Passport decision or at the date suggested in the approval letter.

The Innovation Passport holder should complete the TDP submission 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.

You will need to gather the relevant information to complete the following sections:

1. Kick-off meeting and stakeholders
2. About the product development
3. Future development and evidence generation (including if the developer is intending to conduct clinical trials in the UK)
4. Scientific advice
5. Patient engagement including the use of Patient Reported Outcome (PRO) measures
6. Special populations
7. Product life cyclelifecycle
8. Issues to be discussed at the kick-ofkick-off meeting
9. Additional information

After the form has been submitted, you will be invited to meet the MHRA and partner colleagues. The meeting will be held at a mutually acceptable time for the partners and medicine developer. At this meeting you are expected to present a summary of the content of each section of the TDP, highlighting specific challenges and opportunities for discussion and which tools of the toolkit you are interested in using. After the meeting, the partners will develop the TDP roadmap which will be sent to you infollowing 4the to 6 weeks, unless otherwise agreed.meeting.

The TDP toolkit

The toolkit includes innovative and flexible activities designed to help bring clinically important and promising medicines to patients faster and more efficiently. You can choose which elements of the toolkit you want to use to support your programme and partners may suggest specific tools in the future TDP. The TDP is not a requirement to access the ILAP toolkit.

Find out more about the toolkit

The ILAP partners are working to refine and refresh the ILAP which will be launched later in 2024. Further updates will be published on the ILAP website.

Updates

For some products and indications multiple TDP meetings may be required over the development period. A revised and updated TDP should be submitted for regulatory and other stakeholder inputs, with new information highlighted. Progress on specific issues from the previous TDP should be included in this update.

The Innovation Passport Holder or the partners may decide that the TDP has progressed as far as possible and at this point the ILAP will close for the product.

Fees

MHRA

Innovation Passport fee: £3,624 Initial Target Development Profile (TDP) fee: £4,451

The stated fees may be subject to change.

The fee is not refundable if your application is not successful.

You can find out more about our fees and how to pay them.

NICE

NICE’s main contributions to the ILAP will be provided through the NICE Advice service and existing fee structures will be applied.

Find out more about NICE Advice.

Fees from our partner organisations may also apply.

Data sharing and confidentially

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.

ILAP governance

It is important that the activities and decisions of the ILAP partners are managed and coordinated effectively. To ensure effective governance and that patient involvement remains integral to how the pathway operates, a steering group has been set up.

Steering group

ILAP activities are overseen by a cross-partner steering group. The group is mandated to make recommendations for Innovation Passport (IP) applications. The steering group is also responsible for the strategic development and implementation of the ILAP.

Find out more

If you would like help with the Innovation Passport or Target Development Profile email innovationpassport@mhra.gov.uk