A candid look at the European drug regulatory network from a key regulator

摘要

I started off by asking Jytte Lyngvig about the current centralised drug evaluation system as run by the European Medicines Agency, Is it sustainable, for example, that most of the agency's scientific assessors are provided by only a handful or so of the 27 EU member states? It is not a problem in itself that several member states dominate, says Dr Lyngvig. What matters is that the system is not seen as the privilege of just a few players but that it is seen as flexible and open to other member states and to other expertise. Capacity in the area of healthcare regulation varies dramatically from country to country and so, Dr Lyngvig notes, while "you will never have everybody [taking] part in everything... it's important to keep the system open".