"Ненадлежащая производственная практика": модернизация системы обеспечения качества производства лекарственных средств в России
the article describes the stages of the GMP pharmaceutical industry standards transition in Russia, identifies the challenges facing the pharmaceutical industry in transition and points out thes directions of modernization of the quality assurance system for industrial pharmacy
In the article the main tendencies and problems of development of the Russian pharmaceutical industry and the pharmaceutical market are considered. It is shown that low competitiveness of pharmaceutical industry and a high share of an import in the domestic pharmaceutical market are in many respects caused by low innovative activity of the Russian pharmaceutical companies. The contents «Strategy of development of pharmaceutical industry of the Russian Federation for the period till 2020» in interrelation with a complex of system problems of the Russian pharmaceutical industry and prospects of realization of innovative option of its modernization is considered and analysed.
The paper considers the prospects of domestic pharmaceutical industry development and determines the requirements for strategic growth for the drug manufacturers. Particularly highlighted are the results of examining the present situation in the domestic pharmaceutical industry as well as the analysis of international experience. The author determines the main growth aims of the domestic pharmaceutical companies and suggests the measures aimed at their reaching.
The paper examines the structure, governance, and balance sheets of state-controlled banks in Russia, which accounted for over 55 percent of the total assets in the country's banking system in early 2012. The author offers a credible estimate of the size of the country's state banking sector by including banks that are indirectly owned by public organizations. Contrary to some predictions based on the theoretical literature on economic transition, he explains the relatively high profitability and efficiency of Russian state-controlled banks by pointing to their competitive position in such functions as acquisition and disposal of assets on behalf of the government. Also suggested in the paper is a different way of looking at market concentration in Russia (by consolidating the market shares of core state-controlled banks), which produces a picture of a more concentrated market than officially reported. Lastly, one of the author's interesting conclusions is that China provides a better benchmark than the formerly centrally planned economies of Central and Eastern Europe by which to assess the viability of state ownership of banks in Russia and to evaluate the country's banking sector.
The paper examines the principles for the supervision of financial conglomerates proposed by BCBS in the consultative document published in December 2011. Moreover, the article proposes a number of suggestions worked out by the authors within the HSE research team.