Scientific advice

Scientific advice is the term given to formal consultations with regulatory agencies such as the Medicines and Healthcare Products Regulatory Agency (MHRA) or health technology assessment (HTA) agencies such as the National Institute for Health and Care Excellence (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 a single organisation (regulatory or HTA), to parallel, single-country organisations (e.g. MHRA and NICE), to multi-stakeholder parallel advice (e.g. EMA and Joint Scientific Consultation). The status of the advice (whether it is mandatory or formally considered at subsequent submissions) varies by organisation.