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MHRA Guidance: Innovative Licensing and Access Pathway (updation)

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has updated its guidance information on the Innovative Licensing and Access Pathway with figures for Overview of Innovation Passport applications.


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.

Innovation Passport (IP) applications are an innovation passport that enables the creation of a "target development profile," which is a "roadmap" for a product's development using a variety of regulatory tools and flexibilities.


The ILAP is open to both commercial and non-commercial developers of medicines (UK based and or global) and comprises 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.


Medicines in the scope of the ILAP include new chemical entities, biological medicines, new indications, and repurposed medicines.


Applicants will be invited to meet with the MHRA to discuss how their product fulfills the criteria following the meeting, the partners of ILAP will jointly consider if the criteria have been fulfilled and will inform of the outcome within 4 weeks.


To apply, the Innovation Passport application form is filled out and submitted in a new part of the MHRA Submissions Portal.


Innovation Passport fee: £3,624 Initial Target Development Profile fee: £4,451 and the stated fees may be subject to change.


Click this LINK for more detailed information.

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