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The ambition of this new licensing and access pathway is to reduce the time to market for innovative medicines. The ILAP combines the MHRA’s globally recognised strengths of independence and
high standards of quality, safety, and efficacy, with improved efficiency and flexibility, readying the MHRA for a new era in medicines approvals in the UK.
Central to realising this ambition is how the ILAP provides a single integrated platform for sustained collaborative working between the MHRA, partners and the medicine developer.
By harnessing expertise at the right time from the MHRA’s partners, the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and NHS England and
NHS Improvement (NHSE&I), the ILAP allows for enhanced coordination and monitoring of important product development activities. Patients are also key partners and the patient voice will be
integrated at every stage.
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.
We are absolutely determined to make sure UK patients can access the latest cutting-edge medicines as quickly as possible to help everybody live longer, healthier and happier lives.
Now we have left the EU, we have the freedom to innovate and cut red tape to speed up the approval process for new treatments and ensure patient safety is at the heart of everything we do.
Transforming the way innovative medicines reach patients in the UK is not a ‘nice to have’. It’s a ‘must do’. An imperative. And the time to do it is now.
Further information about the ILAP and how to apply for an Innovation Passport