MHRA, NICE and SMC are permanent partner organisations and will automatically be included in the development of the TDP. In this section please indicate any additional stakeholders you would be interested in developing the TDP roadmap with, as applicable.

Please provide details of preferred dates for the kick-off meeting.

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

Please indicate specific challenges or novel aspects of your development programme requiring consideration by the partners. Please also indicate which tools of the toolkit you wish to select for the TDP roadmap and why you have selected them.

Scientific advice can be requested at any stage of the development of your medicine. Scientific advice is not legally binding, but provides a framework to address specific scientific, regulatory and patient access issues. Please state if you have received scientific advice from a regulatory authority or other body and for future advice indicate which stakeholders and topics you would be interested in covering.

Patient engagement (PE) can be described as the effective and active collaboration of patients, patient advocates, patient representatives and/or carers in the processes and decisions within the medicine lifecycle, along with all other relevant stakeholders when appropriate (PARADIGM, 2018). Please indicate if you have already engaged with patients with this development programme. Please provide details of what additional future approaches you have identified for patient engagement and what you would like to gain from new or further patient engagement.

Special Population

Please describe your development plans in paediatric patients (defined as from birth, including preterm neonates to less than 18 years) including reasoning for excluding one or all paediatric cohorts from your plans. Have you considered including adolescents in the adult trials (if scientifically appropriate) to streamline prompt evidence generation? Please indicate what is the status of your paediatric investigation plan (PIP) if applicable. A PIP is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for children. Compliance with a PIP is a mandatory requirement in certain GB MA applications and also leads to further rewards.

How are you considering elderly patients in your development: If relevant to your patient population please indicate how you have considered elderly patients in your clinical development programme and ensured that the medicine used by older people is of high quality and are studied appropriately.

How are you considering women’s health (including pregnancy) in your development: Please indicate where you have considered women’s health in your development plan in order to better understand the benefits and risks of medicines in women and in particular during pregnancy and breastfeeding.

Please indicate if your product is being developed in a rare disease and if you intend to seek orphan status: If relevant to your patient population please indicate if you are considering seeking orphan status in Great Britain. The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application and will offer incentives in the form of market exclusivity and full or partial refunds for marketing authorisation fees.

Product Lifecycle

Please indicate the likely sequence of indications from first approval, if known.

Please indicate if there is the possibility to repurpose your medicine in another condition (new indications), if known: Based on the mechanism of action, it may be possible to expand the population label, offering significant benefits to patients and health systems. Please indicate if you have considered or know of potential new uses outside of the current therapeutic area or new patients’ cohorts such as children or other special populations.

How will you collect real world data (RWD) post approval: Real-world data are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Please indicate if you are interested in collecting RWD and for what purpose.

Are you interested in reclassification of your medicine in the future: The legal classification of a pack of medicine determines the level of control over its supply and there are three categories in the UK; Prescription-only (POM), pharmacy and general sale list (GSL) medicines. The legal classification of a medicine may change (reclassification) e.g. Prescription-only medicine (POM) to pharmacy (P) medicine. Please indicate if you have any current ambitions for reclassification.

I understand that the information on this form will be held on a secure, shared digital platform for access by the MHRA and organisations within the partnership.