Affiliations: Pharmaceutical Technology Department, Faculty of Pharmacy, University of Granada, Granada,
Spain. Tel.: +34 958 243898/99; E-mail: mcabezas@ugr.es
Abstract: A major revision of the pharmacovigilance legislation came into
force in the European Union (EU) in 2010 and applies from July 2012. A
technical implementing regulation and detailed guidance have been issued in
2012 to facilitate this enhancement of EudraVigilance. Major emphasis has been
put on further strengthening the role of EudraVigilance as regards simplifying
adverse reaction reporting, collecting adverse reactions, detecting new risks,
monitoring known or potential risks and providing stakeholders with adequate
access to adverse reaction data. The legislation has created the Pharmacovigilance Risk Assessment Committee that is responsible for assessing
all aspects of the risk management of medicines for human use. The Risk
management system are a set of pharmacovigilance activities and interventions
designed to identify, characterise, prevent or minimise risks relating to
medicinal products. The requirements in the Directive and Regulation include
provisions for post-authorisation efficacy studies, in addition to
post-authorisation safety studies.