The New EU Pharmacovigilance Legislation: A Giant Leap

As the new EU Pharmacovigilance legislation comes to effect, to what extent it could drive changes in the Pharmacovigilance services worth ruminating. Touted to be the biggest change to the legal framework in human medicines since 1995, it would be too na??ve to limit its implications on only a few outcomes: rather it will have a far reaching effect in both the US and the EU drug manufacturers. One of the several reasons of such an implementation is to promote and enhance proactive drug safety, which is related to the adverse event reporting. Lately the pharma industry has seen growth in the reporting of adverse events, drug failures and subsequently causing harm to the patients. This regulation would increase the reporting of adverse events, though in a more coherent and a streamlined way, conducting more safety and efficacy studies.?? This would also see more transparency in the functions of the member states, authorities like EMEA and improved methods of establishing communication.