For a justification of ‘significant’, the magnitude of the issue(s) should be discussed in a problem statement along with the identified gaps that remain in the current treatment landscape. This evidence is likely to be generated from information in the public domain and or patient engagement activities. Submissions for significant patient or public health need you are required to provide clearly defined evidence of a specific need (for example, a need for paediatric formulation, anti-microbial resistance), putting the need into the context of the current patient or public health setting. If you are applying under the first characteristic, you will be expected to provide a summary of the condition and the life threatening or seriously debilitating nature including symptoms, life span and quality of life aspects and current treatment landscape. This is not necessarily linked to the product as it sets out the grounds for the need to develop a medicinal product in a particular area. there is a significant patient or public health need.the condition is life-threatening or seriously debilitating.Criteria 1: details of the condition, patient or public health area The criteria for the passport are listed below, with the types of expected data. However, a single positive Innovation Passport can cover multiple indications for the same medicine (active substance) in the TDP. In most cases you are expected to submit data around your lead indication and you must submit an Innovation Passport application for each separate medicinal product (different active substances). The Innovation Passport does not replace the Promising Innovative Medicine ( PIM) Designation of the EAMS and you can apply for both initiatives. The evidence required for a product to fulfil the criteria will depend on where in the development pathway the product is and can be based on non-clinical data. This designation is linked to a portfolio of activities through the creation of a product-specific Target Development Profile. The passport includes a broad and inclusive definition of innovation and both new and repurposed medicines are within scope. 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 first step in the ILAP is the Innovation Passport application. National Institute for Health Research ( NIHR)Įligibility through the Innovation Passport.National Institute for Health and Care Excellence ( NICE).The Medicines and Healthcare products Regulatory Agency ( MHRA).The All Wales Therapeutics and Toxicology Centre.The ILAP provides you with opportunities for enhanced regulatory and other stakeholder input. 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 is open to both commercial and non-commercial developers of medicines (UK based and or global). 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. These medicines include new chemical entities, biological medicines, new indications and repurposed medicines. The Innovative Licensing and Access Pathway ( ILAP) aims to accelerate the time to market, facilitating patient access to medicines.
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