What is the Joint Scientific Consultation process?
What is the Joint Scientific Consultation process?
Joint Scientific Consultation should occur after a health technology’s early developmental stage but before the health technology is on the market and has undergone a Joint Clinical Assessment (Recital 46).
Medicinal Products
JSC for medicinal products may occur in parallel and have synchronised timing with scientific advice from the European Medicines Agency (EMA) on the conduct of the various tests and trials necessary to demonstrate the quality, safety, and efficacy of a medicinal product (Article 16(5)).
JSC for medical devices may occur in parallel with the consultation of expert panels consisting of advisors appointed by the European Commission based on relevant expertise with the aim of reviewing a health technology developer’s clinical development strategy and proposals for clinical investigation (Article 16(5)).
Figure 3 provides an overview of the steps involved in a Joint Scientific Consultation.
Figure 3: Overview of Joint Scientific Consultation procedure. Wolf See