Abstract
The European Community's (EC) current legislative requirements (Council Regulation 2309/93 and Council Directive 93/39/EEC) for expedited and periodic adverse drug reaction (ADR) reporting for medicinal products marketed within the EC have been effective since January 1, 1995. They have been known as the “Future System” and have been supported by guidance provided within the draft Notice to Applicants (December 1994). Thus far, the Future System has not been effective in achieving harmonization of pharmacovigilance within Europe. Full implementation has yet to occur in many EC countries and, where it has occurred, variations in national interpretation of the legislation have occurred. Furthermore, inconsistencies exist between the regulation and the directive, between them and the Notice to Applicants, and also with respect to recommendations from the International Conference on Harmonization.
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