The UK is spearheading a new initiative on how innovative medicinal products can be brought to market faster and therefore made accessible to patients more quickly. In December 2020, the MHRA released new guidance documents on ILAP or Innovative Licensing and Access Pathway to clarify new opportunities for stakeholders in medicinal product development. Already operational, this initiative encourages early pipeline discussions between stakeholders. The aim of ILAP is to accelerate the time it takes to get a medicinal product to market and does not replace the Early Access to Medicines Scheme in areas of unmet medical needs. The Pathway brings together innovative approaches to support the safe, timely and efficient development of innovative products.

What are the criteria for acceptance to the new Pathway?

To take part in ILAP, interested parties have to submit an Innovative Passport application for each medicinal product. This process is open from the pre-clinical trial phase through to mid-development and the Passport itself contains a broad and inclusive definition of ‘Innovation’. To fulfill the Passport requirements, the following criteria have to be met:

  • Criteria 1: details of the condition, patient or public health area.
    a) the condition is life threatening or seriously debilitating or
    b) there is a significant patient or public health need
  • Criteria 2: the medicinal product fulfils one or more of the following areas
    a) Innovative medicine such as an advanced therapy medicinal product or new chemical or biological entity or novel drug device combination
    b) The medicine is being developed in a clinically significant new indication
    c) Medicine for rare disease and/or special populations such as neonates, children, pregnant women and the elderly
    d) Development aligns with the objectives for UK public health priorities.
  • Criteria 3: the medicinal product has the potential to offer benefits to patients
    For this criterion the applicant is expected to 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.

What Regulatory Tools are utilised?

ILAP utilises Regulatory Tools supporting the following:

• Adaptive inspections
• Certifications
• Continuous Benefit Risk Assessment integrating Real World Evidence
• Clinical Practice Research Datalink (CPRD) Assisted Patient Recruitment
• Enhanced patient engagement
• Innovative and Flexible Licensing Routes
• Novel Methodology and Innovative Clinical Trial Design
• Rapid Clinical Trial Dossier Pre-Assessment

More details about Regulatory Tools including description, benefits and expected use can be found on the MHRA website.

What might the impact be on Regulatory professionals?

There are many areas that might have an impact on Regulatory professionals. One specific area worth mentioning can be found under the section “Innovative and Flexible Licensing Routes”. This Regulatory Tool has the potential to expedite timelines for review and accelerate assessment so valid marketing applications will reach opinion on approvability within 150 days of submission. This option is available for good quality marketing applications for both new and existing active substances.

The other area worth mentioning is “Rolling Review”. It is a new route for marketing applications, offering ongoing regulatory input and feedback. The process is envisaged as a phased, modular, iterative approach of evaluation.

Summary

Overall, ILAP might be the next step that supports the safe, timely and efficient development of innovative products. It is a cutting-edge approach to allow early reviews supported by an increasing number of useful Regulatory Tools that assist stakeholders to make better decisions more quickly, thus bringing medicinal products to the market faster.

Published by Olaf Schoepke

Passionate about sharing ideas with regulatory professionals in the human and veterinary medicinal product space.

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