Scientific advice

Scientific advice (SA) is the most formal and detailed form of interaction between health technology developers and regulatory or HTA agencies.

Scientific advice is a service provided by regulatory agencies to support companies in optimizing the development of their health technology products. This advice covers various aspects of R&D, including clinical trial design, manufacturing processes, and regulatory requirements. The primary aim is to ensure that the data generated during R&D will be robust enough to support a marketing authorization application (MAA).

This process involves comprehensive consultations to address scientific and technical questions related to the development, regulatory approval, and post-market surveillance of health technologies. The name sometimes is different according to the legal role of the regulatory/reimbursement body.

Nevertheless the consultation by these bodies does have a specific topic in relation to the intended use and related legal requirements as well as in relation to comparators e.g.

Scientific advice is crucial for ensuring that the device development aligns with regulatory or reimbursement expectations and scientific standards. It is the last step within a chain starting with Early dialogues and Early Advices to assure awareness of all requested requirements for market access.

References

Scientific advice and protocol assistance | European Medicines Agency (europa.eu)

FDA-EMA Parallel Scientific Advice (PSA) Program - 03/16/2022 | FDA

Benefit Assessment of Medicinal Products - Gemeinsamer Bundesausschuss (g-ba.de)