On the creation of a pharmaceutical safety system in the Russian Federation

This article analyzes the formation and development of a pharmaceutical safety system in the Russian Federation, which was designed to protect the population and health organizations from threats arising in the production, distribution and consumption of pharmaceuticals. The most difficult period was 1991–1998, which was characterized by a sharp decline in the pharmaceutical industry’s economic potential in connection with the transition to new, market-based management mechanisms and the lack of an adequate regulatory framework for pharmaceutical management. A second period began after the adoption in 1998 of the federal law On Medicines, in which for the first time the priority of state control and regulation of production, manufacturing, quality, efficiency, and safety of medicines was declared. However, opposition from the pharmaceutical industry and the inertia of state authorities in developing a regulatory legal framework detailing federal law provisions did not achieve positive