scholarly journals Validation of predictive pharmacoeconomic model of introduction of medicinal product ibrutinib into chronic lymphatic leukemia therapy practice in the territory of the Russian Federation

2015 ◽  
Vol 3 (3) ◽  
pp. 42-45 ◽  
Author(s):  
R.I. Yagudina ◽  
D.G. Tishchenko
Keyword(s):  
Medicinal Product ◽  
Russian Federation ◽  
Chronic Lymphatic Leukemia ◽  
Lymphatic Leukemia ◽  
Pharmacoeconomic Model ◽  
The Russian Federation

scholarly journals Current Requirements for Information Content and Graphic Design of a Medicinal Product Package

2019 ◽  
Vol 9 (2) ◽  
pp. 108-117
Author(s):  
L. I. Mit'kina ◽  
Anastasiya K. Ericheva
Keyword(s):  
Medicinal Product ◽  
Russian Federation ◽  
Correct Identification ◽  
Medicinal Products ◽  
Federal Law ◽  
Eurasian Economic Union ◽  
The Russian Federation ◽  
Herbal Medicinal ◽  
Labeling Requirements ◽  
Product Package

Labeling is an important source of information about a medicinal product. The completeness and accuracy of labeling ensures correct identification, as well as safe and efficacious use of the product. The aim of the present paper was to perform comparative analysis of requirements for the design of medicinal product packages currently applicable in the Russian Federation and in the Eurasian Economic Union (EEU) in order to facilitate the introduction of Russian medicinal products into the EEU market. The EEU requirements for medicinal product labeling are described in laws and regulations stipulating medicinal products circulation in the EEU. The Russian requirements are laid out in Federal Law No. 61-FZ «On medicines circulation» dated April 12, 2010, the State Pharmacopoeia of the Russian Federation, and the Guideline on Medicinal Products Evaluation of the FSBI «SCEEMP» of the Ministry of Health of Russia. It was demonstrated that labeling requirements described in the EEU and Russian regulations largely overlap, but there are also a number of differences that are mainly related to the information on the medicinal product composition and different interpretation of the term «herbal medicinal product». A successful promotion of Russian medicines in the EEU market will require harmonisation of definitions and requirements used in the Russian legislation with those stipulated in the EEU regulations.

scholarly journals Comparison of Approaches to Stability Testing of Medicines in the Russian Federation and the Eurasian Economic Union

2021 ◽  
Vol 11 (1) ◽  
pp. 16-23
Author(s):  
A. I. Belanova ◽  
E. L. Kovaleva ◽  
L. I. Mit’kina
Keyword(s):  
Medicinal Product ◽  
Russian Federation ◽  
Marketing Authorisation ◽  
Storage Conditions ◽  
Stability Testing ◽  
Medicinal Products ◽  
Regulatory Documents ◽  
Eurasian Economic Union ◽  
The Russian Federation ◽  
Economic Union

Stability testing gives necessary data on the effect of such factors as temperature, light, humidity, etc. on the medicinal product quality. The results of these studies help to select suitable primary and secondary packaging and to determine storage conditions and shelf life for the product. The aim of this study was to compare current requirements for stability testing of medicinal products in the Russian Federation and the Eurasian Economic Union (EAEU). The study covered stability testing of small-molecule medicines. The paper describes evolution of approaches to stability testing in the Russian Federation. It summarises the main differences in basic requirements for stability testing as stipulated in the State Pharmacopoeia of the Russian Federation (Ph. Rus.) XIII edition, Ph. Rus. XIV edition, and EAEU regulations. The study demonstrated that the Russian Federation lacks regulations containing specific requirements for stability testing performed to support variations to marketing authorisation documentation. The Ph. Rus. XIV edition does not specify the extent of stability testing to be performed after switching to another manufacturer of the active ingredient or introduction into operation of a new manufacturing site where the medicinal product will be produced. At the same time, the EAEU regulatory documents contain requirements for stability testing for each type of the most frequent variations to marketing authorisation documentation. The study demonstrated the continuing relevance of bringing the Russian regulations on stability testing in line with those of the EAEU.

Prospects of development of the reference base of the Russian Federation in the field of length measurements

2020 ◽  
pp. 3-5
Author(s):  
Y. G. Zakharenko ◽  
N. A. Kononova ◽  
V. L. Fedorin ◽  
Z. V. Fomkina ◽  
K. V. Chekirda
Keyword(s):  
High Precision ◽  
Russian Federation ◽  
Reference Base ◽  
Length Measurements ◽  
Laser Sources ◽  
The Russian Federation ◽  
Unit Of Length ◽  
Further Development ◽  
532 Nm

The results of the work to create a complex of high-precision hardware for the unit of length reproduction and transferring carried out at “D. I. Mendeleyev Institute for Metrology (VNIIM)” are represented. This complex will serve as the basis for the further development of the reference base of the Russian Federation in the field of length measurements and will allow reproduction of the unit of length at two wavelengths of 633 nm and 532 nm, as well as measurements of the wavelength of laser sources in vacuum in the range from 500 to 1050 nm.

Assessment of the state and level of development of public-private partnership projects in the subjects of the Russian Federation

2018 ◽  
pp. 131-141 ◽  
Author(s):  
A. N. Savrukov ◽  
N. T. Savrukov ◽  
E. A. Kozlovskaya
Keyword(s):  
Detailed Analysis ◽  
Russian Federation ◽  
Significant Proportion ◽  
Transport Sector ◽  
Private Partnership ◽  
Current State ◽  
Central Regions ◽  
The Russian Federation ◽  
Project Data ◽  
Municipal Level

The article analyzes the current state and level of development of publicprivate partnership (PPP) projects in the subjects of the Russian Federation. The authors conclude that a significant proportion of projects is implemented on a concession basis at the municipal level in the communal sphere. A detailed analysis of the project data showed that the structure of the projects is deformed in favor of the central regions of the Russian Federation, and a significant share in the total amount of financing falls on the transport sector. At the stage of assessing the level of development by the subjects of the Russian Federation, criteria were proposed, and index and integral indicators were used, which ensured comparability of the estimates obtained. At the end of the analysis, the regions were ranked and clustered according to the level of PPP development, which allowed to reveal the number and structure of leaders and outsiders.

Assessing the size of agricultural holdings

2020 ◽  
pp. 105-116
Author(s):  
N. I. Shagaida
Keyword(s):  
Russian Federation ◽  
Vertical Integration ◽  
Total Revenue ◽  
Large Share ◽  
State Support ◽  
The Russian Federation ◽  
Agricultural Organizations ◽  
Business Entities ◽  
To Receive

The article clarifies the concept of “agricultural holding”, using an approach to assessing the size on the basis of the total revenue of all agricultural organizations within the agricultural holding. It has been revealed that only 100 of the total number of agricultural holdings that were identified can be attributed to large business entities. They comprise about 3% of agricultural organizations in the country, while their share in the proceeds is about 37%. A large share of agricultural holdings — large business subjects under the control of Russian entities operate in one, and under the control of foreign legal entities — in three or more regions of the Russian Federation. Vertical integration within the framework of large agricultural holdings with different schemes for including the stages of processing and sale of products produced in their agricultural organizations allows them to receive advantages. Strengthening the role of large business entities in agriculture puts on the agenda the issue of differentiating approaches to taxation and state support in agriculture, depending on the size of the companies’ agricultural businesses.

Foreign Direct Investments: The Indirect Way to Economy

2007 ◽  
pp. 63-75 ◽  
Author(s):  
A. Navoi
Keyword(s):  
Russian Federation ◽  
National Economy ◽  
Financial Resources ◽  
Foreign Direct Investments ◽  
Russian Economy ◽  
The Russian Federation ◽  
Methodological Aspects

The article analyzes the situation with attraction of foreign direct investments (FDI) into the Russian Federation. Sharply increased inflow of international financial resources into national economy has highlighted the problem of definitions, the reasons of this phenomenon and its economic contents. The article considers methodological aspects and economic essence of modern FDI. Special accent is made on the estimation of the situation with their attraction into Russia, FDI structure and effectiveness. The conclusions about basic directions of the increase of their effectiveness in the Russian economy are formulated.

Sign in / Sign up

Export Citation Format

Share Document