New European legislation on pharmacovigilance

The European Parliament and the Council of the European Union have recently adopted Regulation (EU) No 1235/2010 ^1 and Directive 2010/84/EU ^2 concerning the pharmacovigilance of medicinal products for human use. These and other European institutions have been laying down rules on the subject for decades, but this is the first time they have enacted legislation specifically and (almost) exclusively regulating pharmacovigilance. This paper analyzes the context, causes, objectives, key points and challenges of the new legislation.