The refreshed Innovative Licensing and Access Pathway (ILAP) is setting a new global benchmark for accelerating patient access to transformative medicines in the UK. More than just a regulatory pathway, the ILAP is the first end-to-end access pathway that brings together medicine developers with UK regulators and the National Health Service (NHS) though a genuinely collaborative and joined-up approach.
By enabling earlier and better coordinated engagement with ILAP partners, the pathway helps developers to de-risk their programmes, plan evidence generation more effectively and smooth the route to adoption across the health system. At the heart of the ILAP is the Target Development Profile (TDP) which establishes a collaborative platform for the ILAP partners to work with Innovation Passport (IP) holders to review a product’s development.
A more focused Target Development Profile (TDP)The renewed TDP aims to streamline, align and coordinate evidence generation and evaluation, while identifying key implementation and service delivery issues. The ILAP partners work with IP holders to outline critical regulatory and developmental requirements, identifying both potential challenges and opportunities to optimise progression. The result is an evolving document that maps the product’s critical path and advises on the optimal timing and sequence for engaging with ILAP’s related services. The TDP is updated as milestones are reached and new evidence emerges, with ongoing support and engagement maintained through a dedicated ILAP contact.
The new TDP places stronger emphasis on areas that often create challenges in development including:
Evidence generation and alignment across regulatory and HTA expectations CMC (Chemistry, Manufacturing and Controls) helping to surface and address manufacturing and quality risks early Implementation considerations, such as service delivery and health-system readinessThe goal is clear, to deliver insights that help developers refine their development strategy, identify risks earlier, improve predictability, and accelerate progress towards patient access.
Industry welcomes the enhancementsEarly feedback is encouraging and positive: a global pharmaceutical company recently using the redesigned TDP told us about the significant benefits and flexibility offered through the process:
“...we received a high quality and informative TDP readout within the timelines. …we gained confidence in our own regulatory strategy and improved our own internal alignment. Throughout the process, MHRA provided thorough guidance, ad hoc meetings and great flexibility, enabling us to not only submit a detailed TDP Form but have a meaningful discussion at the TDP meeting itself.”
They also highlighted the value of multi-partner coordination:
“The collaboration was characterised by responsiveness, clarity and constructive feedback received from the ILAP Partners. Having used ILAP regularly during its initial launch we can confirm that significant improvements have been made and the process is now much better structured for companies.”
And they outlined the value to them as a medicines developer:
“Most valuable was the summary of key development challenges and the clinical/scientific insight because it reinforced current MHRA and HTA expectations, highlighted potential pitfalls early and strengthened our development strategy. We would recommend the use of ILAP for medicines that meet the eligibility criteria that are early in their clinical development to take full benefit of the advice and tools that this pathway can offer.”
This strong endorsement from industry reflects the new direction of ILAP; easier to use, more responsive and delivering better value for the pharmaceutical sector.
Apply to ILAP nowThe ILAP is open to commercial and non-commercial developers of potentially transformative medicines and drug-device combination products that have:
a therapeutic aim evidence of safe use in humans not yet started confirmatory trials.Applications are accepted continuously, with quarterly selection rounds.
Eligible products that best meet the selection criteria will be awarded an Innovation Passport, unlocking priority access to the ILAP services, including the new, more focused TDP, and a dedicated point of contact.
Be part of the future of medicines accessThe ILAP continues to evolve in partnership with industry, patients and clinical leaders, offering a coordinated way to address development and access challenges early on. Discover more about how it works and what to expect: Innovative Licensing and Access Pathway (ILAP) - GOV.UK.
seen at 10:49, 26 March in MedRegs.