ILAP Innovation Passport - Fusion Pharma

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Innovation Passport (Innovative Licensing and Access Pathway - ILAP)

Medicines and Healthcare products Regulatory Agency (MHRA)

Apply for an Innovation Passport to enter the UK's Innovative Licensing and Access Pathway (ILAP), which provides regulatory support to accelerate the development and market access of innovative medicines. The application takes around 9 minutes to complete and requires a saved PDF of the Innovation Passport Application form.

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Eligibility criteria

The product must be a medicine or drug-device combination product with a therapeutic aim.
The product must not be an immunisation for the prevention of infection and/or disease.
The applicant must be a legal entity with the rights to market the product in the UK.
The proposed product or innovation must be at the stage of clinical development where human safety pharmacology has been preliminarily characterised and there is evidence of safe use in humans and confirmatory trials have not yet started.
There must be an intention to obtain regulatory authorisation to market the health product in the UK, and a commitment to meeting UK Health Technology Assessment (HTA) bodies’ evidential standards to demonstrate cost-effectiveness.
The applicant must commit to working with the ILAP Partners to create a Target Development Profile (TDP).
The applicant must commit to conducting feasibility for opening clinical trial sites in the UK.

Innovation Passport (Innovative Licensing and Access Pathway - ILAP)

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