The refreshed ILAP pathway has been outlined by the UK’s MHRA. Credit: georgeclerk via Getty Images.

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a refreshed Innovative Licensing and Access Pathway (ILAP) to accelerate patient access to new medicines by integrating regulatory and health technology assessment procedures. 

The revised pathway, developed by the MHRA alongside the All Wales Therapeutics and Toxicology Centre (AWTTC), the National Institute for Health and Care Excellence (Nice), the Scottish Medicines Consortium (SMC) and the National Health Service (NHS), aims to streamline collaboration between medicine developers and the national health systems. 

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First introduced in 2021, the pathway was designed to create a single platform for engagement between the MHRA and UK Health Technology Assessment (HTA) bodies. The latest updates reflect feedback from industry stakeholders and recommendations from the Pro-innovation Regulation of Technologies Review. The changes aim to enhance the efficiency and predictability of the approval process while maintaining standards of safety, quality, and effectiveness.  

Under the refreshed pathway, the NHS will be a core partner focusing on system preparedness and operational planning for new medicines. Engagement with patients will be done earlier, and a single point of contact will be assigned for each product. 

The pathway will also provide support for drug-device combinations, which are being investigated in a range of diseases such as cancer and Alzheimer’s disease. For example,  Delcath System is developing its drug-device combo Hepzato Kit (melphalan/hepatic delivery system) as an add-on treatment for patients with liver-dominant metastatic colorectal cancer (mCRC) and started enrolment in a Phase II trial studying it in December 2024. 

The MHRA outlined plans for the revised ILAP in its 2024/25 business plan, which identified improved patient access to safe and effective products as a priority. The agency, along with its ILAP partners, committed to an iterative approach, allowing for further refinements to be based on industry needs and regulatory developments. 

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Several companies have already used ILAP to enable their medicines to be accessible on the NHS. UK-based biotech LightOx has developed LXD191, a light-activated drug designed to eliminate pre-cancerous and cancerous cells at an early stage. The company – which aims to bring the drug to the clinic this year – plans to use the ILAP to enter Project Orbis, an international regulatory incentive, which also involves the US Food and Drug Administration (FDA), to accelerate the approval of oncology treatments. The MHRA joined Project Orbis in 2021 to support faster patient access to cancer therapies.