The Innovation Access Pathway (ILAP) initiative aims to provide drug developers with safe and early access to medicines in the UK market. By fostering collaboration among partners and supporting pharmaceutical companies, ILAP streamlines the development process, offers expedited routes, and addresses commercial and access issues. With regulators and health technology assessment agencies working hand in hand, ILAP ensures comprehensive involvement right from the start.

The ILAP initiatives support drug developers (UK or global) to engage with key stakeholders early and consistently throughout the journey from early development right through to patient access. Medicines in scope of the ILAP include new chemical entities, biological medicines, new indications, and repurposed medicines. Successful applicants will receive an Innovation Passport Designation and gain exclusive access to the Target Development Profile (TDP) support toolkit.

The Innovation Passport Designation serves as the required entry point to ILAP. What sets ILAP apart is its ability to bring together the functions of various organizations, including The Medicines and Healthcare products Regulatory Agency (MHRA), National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), and The All Wales Therapeutics and Toxicology Centre collaboratively, fostering collaborative and efficient processes. Supporting partners include the Health Research Authority (HRA), the National Institute for Health Research (NIHR) and NHS England and NHS Improvement.

ILAP offers flexible entry points based on factors such as the stage of product development, available data, and a willingness to embrace innovative working methods and stakeholder engagement. The pathway allows for early entry based on non-clinical data and can also accommodate products with mid-development "global" dossiers. However, it is highly recommended to apply early in the product development stage to maximize the potential benefits available. Generally, products nearing the end of their development program may not be suitable for ILAP, bearing in mind at this late stage of development there is less opportunity for ILAP to add value to the overall development program. There are three passport entry criteria:

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

• The condition targeted by the medicinal product is life-threatening or seriously debilitating.
• There is a significant patient or public health need.

Criteria 2: The medicinal product fulfils one or more of a specific area, such as:

• Innovative medicines like advanced therapy medicinal products, new chemical or biological entities, or novel drug-device combinations.
• Medicines being developed for clinically significant indications related to approved medicines.
• Medicines targeting rare diseases and/or special populations.
• Development aligned with the objectives of UK public health priorities.

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

• A summary of the likely benefit to patients, as compared to exiting therapeutic options, must be provided.

When the application has been submitted, the MHRA will invite the applicant to a meeting to discuss how the product fulfils the Innovation Passport criteria and thereafter, the partners will jointly consider if the criteria have been fulfilled and if an Innovation Passport is granted.

Once the Innovation Passport designation is achieved, the development of a Target Development Profile (TDP) is initiated. A TDP kick-off meeting will be arranged to allow sponsors to discuss their product with ILAP partner experts. Subsequently, a TDP Roadmap will be issued. The TDP serves as a tailored roadmap for the product's development, utilizing tools from the TDP toolkit and providing a platform for sustained multi-stakeholder collaboration. This roadmap defines the best approach to address regulatory and market access considerations while identifying potential pitfalls.

The TDP toolkit includes a range of innovative and flexible activities designed to expedite the delivery of clinically important and promising medicines to patients. It adopts a life cycle approach to evidence generation while ensuring regulatory compliance through mandatory aspects. Sponsors can request relevant tools through the Target Development Profile (TDP) to support their application.

The currently available tools in the TDP toolkit are:

Compliance Readiness Inspections (CRIs) support regulatory compliance and ensure the safety of medical products, assessing various aspects of a product's development process.

The Certification tool offers regulatory review and feedback on Common Technical Document (CTD) data to aid in marketing authorization.

The Continuous Benefit Risk Assessment tool collects real-world evidence and supports the approval of innovative medicines.

Clinical Practice Research Datalink Assisted Patient Recruitment helps identify potential trial participants from health records.

The patient engagement tool involves patients in the regulatory process and provides opportunities throughout the ILAP for companies to consider the patient’s experience and voice in a meaningful way during drug the entire drug development pathway.

Innovative and Flexible Licensing Routes offer streamlined approval pathways. The routes are:

Accelerated assessment / Rolling review / Approval with conditions / Conditional Marketing Authorisations / Approval under exceptional circumstances / Project Orbis / Access Consortium

The Novel Methodology and Innovative Clinical Trial Design tool promotes novel approaches in research.

The ILAP HTA Access Forum optimizes market access approaches.

The Rapid Clinical Trial Dossier Pre-Assessment service provides feedback to sponsors before official submission of finalised documents for regulatory review.

Applying for ILAP at an early stage provides opportunities for enhanced input both from MHRA and HTA bodies. ILAP product developers can consult partners at each stage, addressing potential hurdles (perceived or otherwise), gaining knowledge of potential enablers and obtaining concurrent advice for successful market access. Following the guidance throughout the process helps enable a seamless, streamlined journey to market entry.

Are you planning to apply for approval in the UK? Through our extensive experience of MHRA procedures, our team of experts can help you make the right decisions to ensure the most advantageous path to approval for your product.