Events and Milestones on the Road to 1992: A View from 1990

Abstract

Safety monitoring systems are mechanisms, not objectives: the key consideration is the performance of each medicine in terms of safety and efficacy, and this is most attentively observed by the company which developed the product. At the European Community (EC) level, the Commission's February 1990 draft of its future marketing authorization system contained innovative proposals on pharmacovigilance mechanisms — covering definitions, obligations and responsibilities. The principal EFPIA reactions to these proposals included: the need for EC systems to correspond to developments elsewhere (eg, CIOMS); the need for close and early contact with a firm on any safety monitoring question relating to its product; and the need for operational aspects (such as timetables and mechanisms) to take account of industry experience of the practical realities of international monitoring and reporting.