Expert teams meet as part of the Pharma Dialogue
Two of the four expert teams that were set up to oversee the implementation of the results and the continuation of the German government’s Pharma Dialogue met in January.
The team tasked with reducing red tape (Kompetenzteam Bürokratieabbau) discussed the obstacles that regulatory requirements – in particular duplicate requirements (at the national and state level) – create for pharmaceutical development and approval. The businesses also made it clear that approvals for new production sites also involved a lot of red tape because they have to comply with numerous different permits. Combining all of these into a single permit would simplify things considerably, they said.
During the meeting of the team focusing on new technologies and trends (Kompetenzteam neue Techniken und Trends), participants used R&D in Alzheimer’s disease as a template for discussing the potential design of a legal framework that would make it easier to exploit the enormous potential of research. The meeting also examined platform technologies. These offer a wide range of new approaches and cannot always be optimally modelled in the current regulatory development pathways.