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:
- provide a complementary pathway that gives developers coordinated and collaborative support, to enable a system-wide approach for product development and access to the UK market
- apply to an identifiable cohort of potentially transformative technologies that address unmet needs
- reduce the end-to-end timeline for product research and development, regulatory approval, HTA and timely adoption of new technologies to benefit patients, the health systems and the broader economy
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.
The ILAP enables:
- more efficient and joined up progress through the UK medicines development landscape to facilitate the most appropriate route for rapid access (removing inefficiencies and costs associated with independent interactions) with enhanced ability for parallel evaluation of data by multiple organisations, as well as data sharing
- reduction in unnecessary delays to patients accessing innovative and transformative medicines and supports navigation of the UK regulatory and HTA processes
- early and ongoing interaction with the MHRA, HTA bodies and the NHS to enhance understanding and access to the different elements of the UK access pathway
- more predictable timelines, enabling developers to plan more effectively
- early interactions with patients and the NHS to facilitate smoother routes for routine access and system-wide adoption
- priority access to regulatory and HTA services
Excerpt from the official page. The original is authoritative. Continue reading at UK MHRA ↗