Shaping European Early Dialogues: The Seed Project.

Recommendation by the High Level Pharmaceutical Forum (2008): national authorities and companies to be engaged in early dialogues with the aim of improving the generation of appropriate data for products in development (Recommendation 6). First Early Dialogue Initiatives: ‘single HTA’ advice (since 2009) and parallel regulatory HTA advice organized by the EMA with a limited number of HTA bodies (since 2010). On this basis, early dialogues (EDs) were set up with 2 additional specificities: a collaborative approach and an extension to include medical devices.