About the product development
Global regulatory status: Please indicate regulatory milestones of your product to date.
Proposed clinical indication(s) or medical condition: Please indicate the proposed population to treat for your first indication if a new product or, if an approved product, the indication you wish to discuss in this TDP. Other regulatory reviews: Please provide a list of other authorities whose review and authorisation may be required during the development of your product. Examples include, but are not limited to, Health and Safety Executive (HSE) and/or Department for Environment Food & Rural Affairs (DEFRA) for products classified as genetically modified organisms, Human Tissues Authority (HTA) and / or Human Fertilisation and Embryology Authority (HFEA).
How will this product benefit patients: It is important to understand how the product will benefit patients, therefore please provide a statement. This might include major advantage over existing products, additional therapeutic option, beneficial route of administration or other aspect. Please indicate how you will demonstrate patient benefit.
Summary of quality development programme: Please provide a summary of the manufacturing and control aspects of your drug substance and product; together with dosage form design, formulation, packaging and medical device aspects where relevant.
Summary of non-clinical development programme: Please provide a summary of the non-clinical aspects of your product, including completeness of studies.
Summary of clinical development programme: Please provide a summary of the clinical aspects of your product and indicate the current stage of development.
Associated medical device details (if required): If your medicinal product requires a medical device for administration or some other aspect for patient treatment, please include details, including the conformity aspects.
Associated in vitro diagnostic (IVD) details (if required): If your medicinal product requires an IVD for patient selection, please include details, including the conformity status
Proposed clinical indication(s) or medical condition
Medicine or Device global regulatory status including specific milestone dates
Other regulatory reviews e.g. HSE
How will this product benefit patients and how will this be demonstrated
Summary of quality development programme
Summary of non-clinical development programme
Summary of clinical development programme including top line data and ongoing studies
Associated medical device details (if required)
Associated in vitro diagnostic details (if required)