Drug Safety in the European Community

Summary

By 1992 the European Community’s pharmaceutical legislation will cover all industrially produced medicines, including vaccines, blood products and radiopharmaceuticals. The quality, safety and efficacy requirements have been harmonised, as have certain aspects of procedures for marketing authorisation or for manufacture. The complete texts of the ‘Rules Governing Medicinal Products in the European Community’ were published recently.

Pharmaceutical companies have 2 types of European Community registration procedures available, which are intended to facilitate the adoption of a common position by the member states. The experience gained with the procedures of the Committee for Proprietary Medicinal Products (CPMP) has highlighted opportunities for closer cooperation, either before national decisions (concertation procedure) or after such decisions (multi-state procedure). The installation, in 1993, of a single European market without borders implies that medicinal products should be able to circulate throughout the European Community with the same conditions attached to their marketing.

Monitoring the adverse effects of medicinal products (pharmacovigilance) is also a major issue. The existing arrangements for exchanging postmarketing information will be reinforced, in future, by strengthening the legal provisions already in force.