Criteria 2: the medicinal product fulfils one or more of a specific area (indicate which are applicable in your application).Ī) innovative medicine such as an advanced therapy medicinal product ( ATMP) or new chemical or biological entity or novel drug device combinationī) medicines being developed in a clinically significant new indication for an approved medicineĬ) medicines for rare disease and/or other special populations such as neonates and children, elderly and pregnant womenĭ) development aligning with the objectives for UK public health priorities such as the Chief Medical Officer, Department of Health and Social Care ( DHSC) or Life Sciences Sector Deal (including those in Devolved Administrations, where appropriate)įor this criterion the applicant is expected to indicate which area(s) the product belongs to.ĭepending on the area, you must provide the following evidence:Ī) a full regulatory description of the product is expected so that the product status can be determined (e.g. 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.
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