REQUIREMENTS OF DRUG PRODUCT REGISTRATION IN RUSSIA

Abstract

Russia is poised to be among the top five Global pharmaceutical markets in terms of value in the next five years. The registration is a state procedure of drug quality, efficacy and safety evaluation to obtain an approval for medical use of a drug in the Russian Federation. The designated federal executive authority regulating drug registration issues is the Ministry of Health of the Russian Federation. This is due to the heterogeneity in the regulatory landscape of the various countries. Therefore, to meet these challenges, a lot of strategic planning is required before the development of any generic drug product. Registration should be seen as a critical step in ensuring access to safe and effective medicinal product