Impact on the Availability of Food Supplements and Medicines in the Russian Federation during Legislative Changes in 2010 : A Case Study

Abstract

Until the change in drug legislation in 2010, the Russian Federation (RF) tried to follow the world-recognised guidelines of the US and European food supplement and drug registration legislation. After introducing the new pharmaceutical law (NPL), a unique legal system was created that did not correspond to international practice. At the same time, legislation on food supplements (FSs) remained the same corresponding to worldwide accepted practice. Consequently, restructuring of regulatory authorities was implemented. There was no pathway or authority restructuring for FSs in the same period. The present study aimed to analyse the legislative change burden on the availability of food supplements and medicines in the RF during the most turbulent period from 2010 to 2012. Before the NPL, 20,836 drugs and 5000 food supplements (FSs) were registered. After the NPL, the number of registered drugs significantly fell, while the number of registered FSs grew, showing a 90% increase. During the observational period, the number of registered FSs grew, and the registration process was stable. Meanwhile, a reduced quantity of registered medicines was observed, and the decline was −21.25%. Moreover, decreased productivity of regulatory authorities was noted, and the drug MAs issued per year fell by −64.11%.