The evolving horizon of drug registration — Europe and beyond

Summary

The thalidomide tragedy gave rise to national drug regulation without thought to international harmonization. Thus from the early days of the European Community (EC), there has been a barrier to the free movement of medicinal products. Previous attempts have failed to resolve the problem and the European Commission is currently involved in attempting to establish Community drug legislation which will remove these barriers and create a single internal market.

The Commission advocates two procedures (a centralized and a decentralized) largely under the control of the Committee for Proprietary Medicinal Products (CPMP) within the framework of a new European Agency for the Evaluation of Medicinal Products. The present authority of the Commission to make decisions binding on all 12 Member States will be utilized by the CPMP.

While the present draft legislation should create significant improvement towards the goal of a single market, it contains some areas of potential concern. That this major venture should be a success is not only critical to the EC economy, its research-based pharmaceutical industry and the health care of its citizens but also to the achievement of global harmonization for pharmaceutical marketing authorization for which there is much evidence of enthusiasm and desire.