| アブストラクト | The practice and science of pharmacovigilance first emerged following the disaster caused by thalidomide in 1961, which led to the initiation of systemic international efforts to address drug safety issues spearheaded by the WHO. Systems were developed in member states of the WHO to analyze cases of adverse drug reactions (ADRs) and collate these data into a central database to aid national drug regulatory authorities in improving safety profiles of medicines. Pharmacovigilance is a key public health function for monitoring all medicinal products to assess their quality, efficacy and safety before and following authorization. These medicines are continually assessed to detect any aspect that could compromise their safety, and ensure that the necessary measures are taken. In July 2012, new legislation for pharmacovigilance in the E.U. came into effect as a result of the changes set out in the Directive 2010/84/EU and the European Commission (EC) implementing Regulation (EU) No 520/2012 to reduce the increasing number of ADRs. The latest developments in pharmacovigilance in Europe, including news on E.U. pharmacovigilance legislation, were discussed at the 8th European Generic Medicines Association (EGA) Pharmacovigilance Discussion Forum. The meeting facilitated constructive dialogue between regulators and industry on a range of topics including how to simplify pharmacovigilance activities and improve the processes of risk management plans, periodic safety update reports, signal detection, joint studies and inspections. |
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