What Students Need To Know About New European Pharmacovigilance Legislation.

Pharmacovigilance legislation was developed in a bid to significantly reduce the number of adverse drug reactions, which were found to be causing nearly 200,000 deaths per year in the EU. Many of the challenges in safety monitoring of medicines stem from the limited amount of information available from clinical trials at the time of authorisation of a medicine. Regulators have to strike a balance between making new medicines available for use in patients as early as possible and waiting until sufficient information on a product’s quality, safety and efficacy is known. Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP applies to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities in EU Member States. For marketing authorisation holders and applicants, this results in: • clearer roles and responsibilities; • minimised duplication of effort;