UK sees relaunch of ILAP v2.0

The Innovative Licensing and Access Pathway (ILAP) was first introduced in 2021 to create a pathway for a safe, timely and efficient development of medicines, ultimately improving patient access. This process consisted of two stages: acquiring an Innovation Passport (IP) followed by a Target Development Profile (TDP). However, feedback from stakeholders indicated that the pathway’s offering was not sufficiently clear, the criteria for entry was too permissive and NHS involvement was not strong enough. Additionally, there were overlaps with other regulatory initiatives introduced in 2024, such as the International Recognition Procedure (IRP) and Project Orbis (where the guidance was revised, stating the need for an IP was no longer required). 

In response, the ILAP scheme has been reimagined to incorporate lessons learned while maintaining its focus on expediting patient access to transformative treatments. The new guidance was published on 30 January 2025, with applications opening on 30 March 2025.  

How will the second iteration of ILAP benefit the UK’s Regulatory Landscape? 

The updated ILAP will be the only access pathway where the drug developer can work directly and collaboratively with the UK’s National Health System (NHS), the regulator Medicine’s Healthcare and Regulatory Agency (MHRA) and the health technology assessment (HTA) bodies from the early stages of clinical development. The strengthened collaboration aims to streamline decision-making and ensure that patient access for transformative new medicines is expedited.   

Key updates in ILAP v2.0 include: 

• Refined Entry Criteria: Unlike the previous version, which had more open eligibility, ILAP v2.0 will prioritise only transformative medicines that address significant unmet medical needs within the NHS. This selective approach ensures that the pathway is focused on truly innovative treatments. 

• Stronger NHS Involvement: For the first time, the NHS will be a core partner, contributing directly to operational planning and system preparedness to facilitate seamless integration of new medicines into healthcare pathways. 

• Expanded Scope: ILAP will now accept applications for medicine-device combination products, reflecting the evolving landscape of medical innovation. 

• A More Predictable Roadmap: The updated pathway will provide clearer timelines and structured engagement opportunities, including prioritised scheduling for Joint Scientific Advice (JSA), Access Forums, MHRA scientific advice, and pre-submission meetings. This will help developers better plan and align their regulatory strategies. 

• Improved Alignment with Other Pathways: While ILAP v2.0 remains distinct, it complements the IRP and Project Orbis by offering a UK-centric, collaborative approach to accelerating access. Unlike IRP, which focuses on international recognition, and Project Orbis, which fosters global regulatory collaboration, ILAP provides an integrated UK pathway that supports early engagement across multiple national healthcare stakeholders. 

Is the new ILAP right for your product? 

If you are developing a medicinal product or combination product that could benefit from ILAP’s redefined framework, now is the time to act. If you have questions or face challenges with your development pathway, tranScrip regulatory and clinical experts are at the ready to guide and advise you; we are ready to expedite your development programmes and bring effective medicines to patients across the UK and beyond.