Ivan M. Chizh,
Elena Yu. Lemeshenko,
Andrey B. Goryachev,
Oleg N. Afanasiev
FSAEI HE I.M. Sechenov First MSMU MOH Russia (Sechenov University)
8 Trubetskaya St., building 2, Moscow 119991, Russia

This article analyzes the formation and development of a pharmaceutical safety system for 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 results. Therefore, in 2009, the “Strategy for the development of the pharmaceutical industry of the Russian Federation for the period until 2020” was approve, marking the beginning of the modern period of improving the pharmaceutical safety system. The new federal law “On distribution of medicines” (2010) with the necessary set of normative legal acts and the “Strategy for the provision of medicines to the population of the Russian Federation for the period until 2025” (2013) set out a sequence of tasks for solving problems concerning the country’s medicinal independence and providing the population with the necessary pharmaceutical products. In general, it is noted that the level of pharmaceutical safety has increased in Russia. The authors point out that the concept of “pharmaceutical safety” has undergone changes and currently presupposes not only a patient’s personal safety when using medicines, but also the country’s medicinal independence.