Scientific advice is the term given to formal consultations with regulator agencies such as MHRA or health technology assessment agencies such as NICE, in advance of making submissions for marketing authorisation or reimbursement. Most frequently the consultations concern the design of confirmatory (Phase 3) studies – the objective being to understand if the proposed design and analyses are realistic and will deliver data that are useful for decision making. More recently an increasing number of consultations have been earlier (about whole programmes of studies for a new medicine) or later (about peri- and post-launch study designs) in product development. There are a variety of options for undertaking Scientific Advice from single organisation (regulatory of HTA) to parallel- single country (e.g. MHRA and NICE) to multi-stakeholder parallel advice (e.g. EMA and many HTAs). The status of the advice (whether it is mandatory or formally considered at subsequent submissions) varies by organisation.


How to cite: Scientific Advice [online]. (2016). York; York Health Economics Consortium; 2016.


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