[The development of regulation of medications turn-over in the EU and the USA in 1992-2020. Report I. The formation of normative legal base of pharmaceutical activities in the USA].

The article considers trends that reflected process of development of globalization of pharmaceutical market at the turn of the 1990s. The expansion of pharmaceutical industry, intensification of research and development in new direction of biopharmaceutics contributed to internationalization of activities of large pharmaceutical manufacturers and to their entrance to foreign markets. The integration of pharmaceutical business of regions with powerful pharmaceutical industry (USA and Western Europe) began, both through international trade and investments into industry and research, as well as due to cooperation between pharmaceutical companies. The obstacle to development of common international pharmaceutical market was discrepancy between national regulatory systems of European countries and the United States. The article highlights most important moments of development of the USA pharmaceutical legislation from 1906 to 2020s. The characteristics of American regulatory system are given. The key provisions that form basis of regulatory framework in the field of circulation of medications are defined.