[Comparison of the safety of the medicinal product in the European Union and the United States, tolcapone (Tasmar) -- COMT inhibitor as the analyzed example]

Abstract

The authors present regulatory procedures and pharmaco-vigilance systems obligatory in the European Union and the United States. The post-approval procedures in the European Union and the United States in case of serious drug reaction (urgent safety restriction) are discussed. Worldwide implementations of the post-approval safety procedure for the tolcapone case are analyzed. Some practical information concerning tolcapone and regulatory procedures obligatory in the European Union and the United States is included.