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Updated Guidance on Innovative Licensing and Access Pathway - MHRA

This new pathway supports innovative approaches to the safe, timely, and efficient development of medicines to improve patient access.


The Innovative Licensing and Access Pathway (ILAP) aims to accelerate the time to market, facilitating patient access to medicines. These medicines include new chemical entities, biological medicines, new indications and repurposed medicines.


Horizon scanning and regulatory science will make sure the pathway is at the forefront of cutting-edge developments and has the framework to develop evidence-based practice as new technologies and methods emerge.


The ILAP is open to both commercial and non-commercial developers of medicines (UK based and or global). It comprises of an Innovation Passport designation, a Target Development Profile (TDP) and provides applicants with access to a toolkit to support all stages of the design, development and approvals process.


The ILAP provides you with opportunities for enhanced regulatory and other stakeholder input.


The first step in the ILAP is the Innovation Passport application. The Innovation Passport is the mandated entry point to the ILAP and is open to developers at the pre-clinical trial stage through to the mid-development programme point.


The passport includes a broad and inclusive definition of innovation and both new and repurposed medicines are within scope.


For more detailed information on the criteria for the Innovation Passport application click this LINK

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