The regulation of medicines post 1992.
The European Community (EC) is scheduled to become a fully integrated market by 1992. Currently the present national variations in pharmaceutical marketing authorization constitutes an unresolved barrier. The need is for agreed and clearly specified requirements to afford EC wide marketing authorization within agreed time frames. Great care will be required to avoid such problems as a European drug-lag and mounting cost, to the detriment of patients, government, and the research-based pharmaceutical industry.
Currie
W J
WJ
Merck Sharp & Dohme Research Laboratories, Rahway, New Jersey.
D005062:European Union; D007880:Legislation, Drug / Q000639:trends*