The evolution of EU and US pharmacovigilance legislation highlights two trends. The first is to strengthen the instruments of protection of human health through, inter alia, the continuous monitoring of the risk-benefit ratio of drugs, greater transparency and the power to penalize producers for the failure to meet the pharmacovigilance obligations. The second trend manifests the partial harmonization of the different pharmacovigilance systems. However, this goal is still far away. In order to achieve it would be necessary to establish an identical definition of adverse drug reaction in both the EU and US legislation.
Recent Developments in EU and US Pharmacovigilance Legislation / MONTANARI VERGALLO, Gianluca. - In: JOURNAL OF PHARMACOVIGILANCE. - ISSN 2329-6887. - ELETTRONICO. - (2013), pp. 1-2. [10.4172/jp.1000e105]
Recent Developments in EU and US Pharmacovigilance Legislation
MONTANARI VERGALLO, GIANLUCA
2013
Abstract
The evolution of EU and US pharmacovigilance legislation highlights two trends. The first is to strengthen the instruments of protection of human health through, inter alia, the continuous monitoring of the risk-benefit ratio of drugs, greater transparency and the power to penalize producers for the failure to meet the pharmacovigilance obligations. The second trend manifests the partial harmonization of the different pharmacovigilance systems. However, this goal is still far away. In order to achieve it would be necessary to establish an identical definition of adverse drug reaction in both the EU and US legislation.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
