The new EU pharmacovigilance rules: a disproportionate burden on industry?
This article was originally published in SRA
Executive Summary
At first glance, the European pharmacovigilance legislation adopted late last year (ie Directive 2010/84/EU1 and Regulation (EU) No 1235/20102) will undoubtedly bring about some welcome changes for marketing authorisation holders. However, there are also changes that may make the life of drug manufacturers more difficult – especially for those producing drugs that are often used off-label.