Snapshot

The Innovative Licensing and Access Pathway (ILAP) pathway has been developed by the Medicines and Healthcare products Regulatory Agency (MHRA) of United Kingdom.

This pathway can be used where The ILAP provides a single integrated platform for sustained collaborative working between the MHRA, partners and the medicine developer. These partners include: National Institute for Health and Care Excellence (NICE), Scottish Medicines Consortium (SMC) (Healthcare Improvement Scotland), National Health Service (NHS England and Improvements), and other organisations such as the Health Research Authority (HRA) and the National Institute for Health Research (NIHR). The “Innovation Passport”, a new medicine designation, acts as the gateway to entry into the pathway and will be awarded to innovative products submitted to the ILAP. This passport step incorporates broad and inclusive concepts of innovation and patient need, allowing the ILAP to encompass a wide range of medicines undergoing development, including Advanced Therapy Medicinal Products (ATMPs), medicines for rare diseases and repurposed medicines. A successful Innovation Passport designation then triggers the MHRA and partners to create the “Target Development Profile” (TDP) document. This “living document” will set out a unique product-specific roadmap towards patient access in the UK healthcare system. The TDP includes access to tools from a toolkit that can be selected to design an efficient and “regulation and access ready” development programme. Available tools include continuous benefit-risk assessment, increased support for novel development approaches and enhanced patient engagement. The ILAP is open to both commercial and non-commercial developers of medicines, and it enables multiple entry points depending on: the stage of development of the product, the data available, the ambition of the applicant to engage with UK stakeholders, and the applicant’s appetite for new innovative ways of working. Therefore, the pathway will allow entry very early, based on non-clinical data, where all the regulatory tools described below might be options, as well as catering for products with mid-development ‘global’ dossiers. However, to maximise the benefits, applicants are encouraged to apply early in the development of their products. Products that are towards the end of their development programme are generally not suitable for the ILAP. The ILAP does not replace the Early Access to Medicines Scheme (EAMS), which remains an important flexibility for earlier patient access towards the end of the development programme in areas of unmet medical need and where major advantage over existing therapies can be demonstrated. The ILAP is broader in scope and is open to all innovative products..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Applicants that wish to apply for an Innovation Passport should complete the relevant submission form. You will then be invited to meet with the MHRA to discuss how your product fulfils the three criteria. Following the meeting, the partners (MHRA, NICE and SMC) will jointly consider if the criteria have been fulfilled and you should be informed of the outcome within 4 weeks.