European registration: today, tomorrow, and beyond.
Within the European Community (EC) countries the national pharmaceutical regulatory systems work with varying degrees of efficiency and scientific sophistication. At the Community level the objective of mutual recognition has failed to be realized. To achieve for one registration application within the EC, timely and simultaneous marketing approvals throughout the member states will require changes to the present regulatory procedures or the single market concept for pharmaceuticals will not be realized. To have the greatest chances for success we should move cautiously, identifying and correcting deficiencies in the present procedures, which are known from experience, rather than abandoning such hard won knowledge for a new system with all its attendant potential unknowns and uncertainty. The free movement of drugs within the Internal European market will be a reality. The question remaining is at what price will it be achieved? It is vital to the European economy and consumer, as well as to the innovative pharmaceutical industry, that Europe does not exchange its present competitive edge in the time to develop and register new drugs for a costly drug lag. The experiment must equally succeed as a torch showing the way forward not only for an enlarging European Community, but also to the ever increasing interest in global harmonization of drug regulation.
Currie
W J
WJ
Department of Regulatory Affairs International, MSDRL, Merck & Co., Inc., Rahway, New Jersey.
D004345:Drug Industry / Q000592:standards*; D005062:European Union; D006801:Humans; D007880:Legislation, Drug / Q000639:trends*; D012957:Societies, Pharmaceutical