Guidance: Innovative Licensing and Access Pathway (ILAP)

The ILAP is now open for Innovation Passport applications, the entry point into the ILAP. Applicants are strongly encouraged to review the eligibility and selection criteria prior to applying through the ILAP registration portal .

The ILAP is a unique initiative which aims to accelerate the time to patient care for transformative new medicines and drug-device combinations, facilitating patient access by providing a single integrated platform for sustained collaborative working between the developer, the regulator (MHRA), the UK health technology assessment (HTA) bodies and the National Health Service (NHS), as well as patients.   

The ILAP is the only end-to-end access pathway in the world where the developer can work collaboratively with the national health system, the regulator and HTA bodies. By engaging with medicine developers from early stages of clinical development with tailored guidance and support, the ILAP aims to facilitate accelerated access through better use of established regulatory and procedural services, facilitated by knowledge gained throughout development to enhance and align evidential requirements, including health system preparedness. It is intended to:  

The ILAP is open to both commercial and non-commercial developers (UK based or global) of potentially transformative medicines or drug-device combination products that have a therapeutic aim and there is evidence of safe use in humans, but confirmatory trials have not yet started.