scholarly journals Description of the System of State Registration of Medicines in the Republic of Georgia as a Development Potential of Domestic Manufacturers

2021 ◽  
Vol 10 (2) ◽  
pp. 155-161
Author(s):  
A. V. Foteeva ◽  
O. S. Barshadskaya ◽  
N. B. Rostova
Keyword(s):  
Russian Federation ◽  
Generic Drugs ◽  
State Regulation ◽  
Republic Of Georgia ◽  
Registration Procedure ◽  
Drug Registration ◽  
The Republic ◽  
Legal Frameworks ◽  
State Registration ◽  
General Aspects

Introduction. One of the main business objectives of Russian pharmaceutical companies is export development. To obtain marketing authorization in countries with a good potential for business it is of greater importance to be competent in drugs registration procedure.Aim. The purpose of this study is to overview general aspects of registration procedure for generic drugs in Georgia for potential launching on pharmaceutical market.Materials and methods. For research purposes we have utilized data obtained from research articles, official websites, regulatory documents for drug registration procedure in both Russian Federation and Republic of Georgia, and documents of registration dossier. Also for this research we have applied benchmarking study, generalized and classified obtained information.Results and discussion. The similarities and differences of drug registration procedure have been determined, e.g. timelines, dossier format, and legal frameworks in both Russian Federation and Republic of Georgia. Also we have emphasized a list of features that could be benefiting for drug registration in Georgia.Conclusion. A review of the state regulation procedure in the field of drug circulation in the Republic of Georgia allows us to conclude that there are favorable conditions for state registration of drugs from a Russian manufacturer.

scholarly journals Товарная интервенция – механизм защиты сельскохозяйственных товаропроизводителей и обеспечение продовольственной безопасности региона

2019 ◽  
pp. 55-66
Author(s):  
Александр Пахомов ◽  
Василий Дарбасов ◽  
Михаил Охлопков ◽  
Екатерина Федорова ◽  
Михаил Соломонов
Keyword(s):  
Russian Federation ◽  
State Regulation ◽  
The State ◽  
Agricultural Products ◽  
Transport Infrastructure ◽  
Wild Plants ◽  
Agricultural Product ◽  
The Russian Federation ◽  
The Republic ◽  
Federal Center

Статья написана в связи с выходом в 2018 г. последней редакции постановления Правительства Российской Федерации «О государственных закупочных интервенциях сельско-хозяйственной продукции». Целью исследования является обоснование продвижения государственного регулирования рынка местной сельскохозяйственной продукции в виде закупочных интервенций в регионах. Проведен анализ существующих зарубежных и отечественных государственных закупочных интервенций, дано обоснование закупочных интервенций в регионе, а также выработаны предложения по продвижению закупочных интервенций с федерального центра в регионы. This article was written in connection with a September 2018 release of the latest edition of a Regulation of the Russian Fed-eration Government on government purchasing interventions of agricultural products. An aim of the authors of the article is substantiation of promotion of the state regulation of a market of the local agricultural products in the form of the purchasing interventions in regions. The authors analyzed the existing for-eign and domestic government purchasing interventions, comments on the latest version of the Regulation of the Russian Federation Government on the govern-ment purchasing interventions, the substantiation of the purchasing interventions in the region and de-velopment of proposals to promote the purchasing interventions from the federal center to the regions. Relevance of the promotion of the purchasing interventions from the federal center to the regions fol-lows from Russian particularity: remoteness of the regions from the center, weak regional transport infrastructure, necessity to replicate a federal technology of the state regulation of the agricultural product market in the regions of the Russian Federation. In the Republic of Sakha (Yakutia), repeated attempts were made to create compensation funds of the regulation of agricultural product prices. However, in the region there is no full-fledged intervention fund effectively influencing sales of the agri-cultural products. Consequently, in conditions of the Republic, where a shortage of the agricultural products, raw materials and food is acute, implementation of the commodity intervention is the neces-sary condition for the regulation of the agricultural market. For the Republic of Sakha (Yakutia), in our opinion, it is advisable to carry out the commodity interventions concerning beef, meat of young horses, venison, fish, dairy products, game, fruits of wild plants and even for rough and succulent fodder for livestock. The latter are relevant due to droughts and floods that regularly occur in a area of the region. Manufacturing costs of the local products will always be higher than the ones of imported food, given the harsh natural and climatic conditions, the remoteness of agricultural commodity producers from the sale markets in the conditions of absence of the transport infrastructure. In this regard, the prices of the local products should be regulated by the state in order to support the local producers. Obviously, the government regulation should not replace market functions or impede operation of its laws. Its main task is to mitigate undesirable consequences of manifestations of market power. One of the main regula-tory methods is the commodity intervention.

scholarly journals The Entry Lag of Innovative Drugs in Russia, 2010–2019

2021 ◽  
Vol 18 (10) ◽  
pp. 5052
Author(s):  
Alexander Chaplenko ◽  
Geliya Gildeeva ◽  
Vasiliy Vlassov
Keyword(s):  
Russian Federation ◽  
Objective Evaluation ◽  
The United States ◽  
State Regulation ◽  
The European Union ◽  
Russian Market ◽  
Drug Registration ◽  
The Russian Federation ◽  
The Moment ◽  
Innovative Drugs

Objective: Evaluation of the lag timelines for the launch of innovative drugs to the Russian market and pharmacoeconomic factors they can depend on. Methods: To complete the investigation, we used information about drug products, namely, dates of submission and approval, and pharmacological groups recovered from national registers and official databases. Results: Due to impacts of market factors and imperfection of the state regulation, original drugs developed abroad enter the Russian market a few years after their registration in the United States of America, the European Union, and Japan. The average time from the moment of initial approval of a drug in the aforementioned countries and jurisdictions to the moment of registration in Russia is 4 years and 8 months, with a median value of 2.5 years. It has been shown that half of this term is spent on the performance of the procedures of the expertise of the drug registration dossier in the Russian Federation. Conclusion: To attain the goal of adequate supplies to the population of the Russian Federation of the most up-to-date, high quality, safe, and efficacious medications, apart from the support of national originators of innovative drugs, we are required to upgrade the existing system of original drug registration. Improvement should be primary focused on the drugs already approved by the leading national regulatory authorities in order to ensure innovative medicine access for Russian patients.

scholarly journals MORBIDITY IN THE REPUBLIC OF SOUTH OSSETIA FOR THE PERIOD FROM 2012 TO 2016 (GENERAL ASPECTS)

2018 ◽  
Vol 21 (1-2) ◽  
pp. 65-69
Author(s):  
S. N Puzin ◽  
I. G Gal ◽  
G. F Totchiev ◽  
Eduard N. Amerkhanov ◽  
N. V Dmitrieva
Keyword(s):  
Russian Federation ◽  
National Health System ◽  
Incidence Rates ◽  
Reference Points ◽  
South Ossetia ◽  
Demographic Groups ◽  
Total Incidence ◽  
The Russian Federation ◽  
The Republic ◽  
General Aspects

The article presents the main indices of the morbidity - the general prevalence and incidence in the Republic of South Ossetia over the period from 2012 to 2016 for the main classes, groups and specific types of diseases, as well as for individual socio-demographic groups: the population over 18 years and children aged up to 18 years. Statistical data of the total incidence for 2012-2015 in The Republic of South Ossetia is considered in comparison with similar indices of the Russian Federation. The material reflecting the ranking of incidence rates per 100 thousand of the population is presented. The analysis of the morbidity, the study of statistical indices of the morbidity, both general prevalence, and incidence, as well as the dynamics over the period of 2012-2016, are the key reference points for the development of a corresponding resource for the emerging national health system of the Republic of South Ossetia. This is of particular interest in the implementation of the integration in cooperation between the Republic of South Ossetia and the Russian Federation.

scholarly journals Spatial socio-economic heterogeneity of rural areas in the Russian Federation

2020 ◽  
Vol 222 ◽  
pp. 06022
Author(s):  
Irina Turgel ◽  
Alexander Pobedin ◽  
Larissa Bozhko
Keyword(s):  
Russian Federation ◽  
Rural Areas ◽  
Spatial Differentiation ◽  
State Regulation ◽  
Ministry Of Education ◽  
Territorial Development ◽  
The Russian Federation ◽  
Industrial Regions ◽  
The Republic ◽  
Degree Of Differentiation

Implementation of objectives set out in the Strategy for sustainable development of rural territories of the Russian Federation until 2030 requires solving the problems of spatial differentiation among rural territories in different regions of Russia. The article analyzes the level of differentiation using a set of socio-economic indicators of rural areas. The coefficient of variation was used as an indicator of the degree of spatial differentiation. In the course of analysis, the authors identified significant disparities in territorial development for most of the considered indicators, and particularly acute differences were found in economic parameters, including the volume of investment at the expense of the municipal budget. It is revealed that the degree of differentiation between rural territories is influenced not so much by economic development success as by the level of urbanization in the region. The empirical basis of the analysis is research results conducted within the framework of the research project “Improving the policy of state regulation of accelerated clustering of industrial regions” (AP05133531), carried out under grant funding from the Ministry of education and science of the Republic of Kazakhstan.

scholarly journals TO THE DEVELOPMENT OF THE FREE ECONOMIC ZONE OF MONGOLIA ALTANBULAG

2020 ◽  
pp. 99-105
Author(s):  
A. Dulguun ◽  
Keyword(s):  
Russian Federation ◽  
State Regulation ◽  
Border Zone ◽  
Foreign Investments ◽  
Free Economic Zone ◽  
Current State ◽  
The Russian Federation ◽  
Economic Zone ◽  
The Republic ◽  
Zone State

This article is devoted to the consideration of the creation and current state of the free economic zone Altanbulag in Mongolia, which is a border zone with the Republic of Buryatia of the Russian Federation. A particular attempt is made to show concisely the current state of this free trade zone, state regulation and actions of the Mongolian government as well as to analyze the issues of attracting foreign investments. The article formulates proposals for improving the Mongolian-Russian cooperation in this free economic zone.

Study of international experience in the field of industrial safety

2021 ◽  
Vol 83 (1) ◽  
pp. 80-91
Author(s):  
I.I. Kolchenko ◽  
◽  
M.V. Temerbaeva ◽  
Keyword(s):  
United States ◽  
Russian Federation ◽  
The United States ◽  
International Experience ◽  
State Regulation ◽  
Industrial Safety ◽  
The European Union ◽  
Technical Documentation ◽  
The Russian Federation ◽  
The Republic

Currently, close attention is paid to industrial safety at hazardous production facilities. Compliance with industrial safety requirements is directly related to the risks of accidents that can lead to man-made disasters, negatively affect the health and life of the population. As in any other industry, there are problems in ensuring industrial safety. There are several reasons for this: the backlog of standards from scientific and technological progress, the exclusive competence of state authorized bodies, and the lack of a risk-based approach. After the collapse of the USSR, the requirements of industrial safety in the Republic of Kazakhstan have practically not changed: laws and statutory instruments (hereinafter-the LSI) are approved and put into effect, after which they are constantly changed and supplemented; the presence of national and international standards, which, in fact, are revised on the basis of the USSR standards, taking into account the influence of the realities of the time. It can be concluded that the current standards are not focused on the future, scientific and technological progress, innovation, so they are constantly undergoing changes, thereby adapting to the necessary requirements that dictate modernity. State regulation does not contribute to the effective development of industrial safety. This is due to the fact that the state performs exclusively supervisory functions (thus it is exclusively educational in nature), and there is no dialogue between authorized state bodies, expert organizations, scientific organizations, and testing laboratories. If we consider the experience of the Russian Federation in the field of industrial safety, then it makes no sense to accept even some experience, since: similar to the Kazakhstan’ LSI and regulatory and technical documentation (and their constant dynamics), the development of cooperation with the Russian Federation within the framework of the Eurasian Economic Union. Accordingly, it is advisable to consider the experience in the field of industrial safety in Europe and the United States of America because of the effectiveness of regulation and supervision than in the Republic of Kazakhstan and the Russian Federation. This article provides information about international experience in the field of industrial safety in the United States and the European Union. The tasks of state regulation in the field of industrial safety in the Republic of Kazakhstan, the Russian Federation, the United States, and the European Union are described in detail. The analysis of normative-legal acts and normative-technical documentation is carried out. Based on the analysis of international experience, solutions to problems in the field of industrial safety for the Republic of Kazakhstan are essentially presented. The purpose of this article is to reveal the problem in the field of industrial safety in the Republic of Kazakhstan and international experience that the Republic of Kazakhstan can borrow in order to effectively ensure industrial safety. Study of international experience (USA, EU countries, Russia) in the field of industrial safety in terms of: analysis of standards; regulation (control and supervisory functions) to ensure safety. The results of this article will reflect the problems that hinder the effective provision of industrial safety in the Republic of Kazakhstan and essentially suggest ways to solve them.

scholarly journals On cooperation of the Russian Federation and the Republic of Kazakhstan within the EAEU in the field of energy and transport

2021 ◽  
pp. 64-67
Author(s):  
S. A. Kalenova
Keyword(s):  
Russian Federation ◽  
Technological Development ◽  
Difficult Problem ◽  
State Regulation ◽  
Energy Resources ◽  
Soviet Period ◽  
Energy Prices ◽  
Scientific Potential ◽  
The Russian Federation ◽  
The Republic

In the context of increasing competition between states, especially in the context of the ever-growing COVID–2019 pandemic, when there is a decline in energy prices, a decrease in the consumption of gas, oil and petroleum products, the correct approach to the use of energy resources of the states this union. especially important for the countries of the Eurasian Economic Union. Also the efficient organization of transport routes for the export of energy resources to foreign international markets is important. The article proposes a scheme of state regulation that can, in our opinion, solve the problems of implementing the strategic priorities of our states, in particular, the Russian Federation and the Republic of Kazakhstan (especially with regard to Kazakhstan's transit opportunities) in the field of energy and transport. The next important step is the further development of industrial and innovative technological development in the field of energy in our countries. The article also notes the problems in the weak integration of the scientific potential of the two countries. It should be emphasized that the collective use of the scientific potential of both states is not such a difficult problem, since in the Soviet period science developed only through joint efforts. Scientific institutes constantly shared their achievements. Joint conferences, symposia and other events were actively held, where it was possible not only to learn about the latest achievements, but also to agree on any joint projects, especially since there is no language barrier between the post-Soviet states.

The Concept of a Trading Network in the Context of the Current Antimonopoly Regulation

2020 ◽  
Vol 15 (8) ◽  
pp. 118-125
Author(s):  
N. N. Karpov
Keyword(s):  
Russian Federation ◽  
Legal Regulation ◽  
State Regulation ◽  
Theoretical Research ◽  
Federal Law ◽  
Judicial Practice ◽  
The Russian Federation ◽  
The Republic ◽  
Definition Of ◽  
Trading Network

The paper analyses and qualifies the concept of "trading network" contained in the Federal Law of 28.12.2009 No. 381-FZ "On the basics of state regulation of trading activities in the Russian Federation" and studies the qualifying features of retail chains. The author considers these features in the context of establishment of antitrust restrictions, taking into account the industry specifics. Based on the results of the analysis of the regulatory framework, theoretical research and judicial practice, the author identifies the problems of law enforcement associated with the definition of the concept, and formulates proposals for improving legislation that can be used by the legislator in order to improve the definition of this concept. The paper analyzes the experience of legal regulation of the retailers’ activities in the Russian Federation, the Republic of Kazakhstan and the Republic of Belarus.

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