Editorial

摘要

The European Medicines Agency has grandiosely described the new EU pharmacovigilance legislation as the "biggest change to the regulation of human medicines" in the region since 1995. This was, of course, the year the EMA was created, ushering in the system of drug evaluation and oversight that Europe has today. Not everybody agrees. Jytte Lyngvig, the head of the Danish Medicines Agency, told the Drug Information Association EuroMeeting in Geneva (Switzerland) at the end of March that it was the biggest change to the system since 2005.This was the year the so-called "New Medicines Legislation" was implemented, bringing substantial change to the EMA and to the original system. That package of legislation, the DMA clarified to Regulatory Affairs Pharma, was "at least as momentous" as the new pharmacovigilance legislation.