scholarly journals The analysis of approaches to conducting bioequivalence studies and the policy of “transparency” of their results in Ukraine, the United States and the European Union

2021 ◽  
Vol 25 (1) ◽  
pp. 32-40
Author(s):  
О.S. Popov ◽  
І.V. Kravchenko ◽  
V.Ye. Dоbrоvа ◽  
K.M. Tkachenko

Providing the population of Ukraine with quality, effective and, at the same time, economically affordable medicines is a priority task of the healthcare system. Taking into account the relatively low cost of their development generic drugs are available to the majority of the country’s population; thus, bioequivalence studies are needed to obtain data on their efficacy and safety. Ukraine is currently in the process of harmonizing domestic regulatory requirements for generic drugs and conducting bioequivalence studies with global ones. Therefore, it is important to find out the differences in approaches to the registration of generics and studies of their bioequivalence in Ukraine and other countries. Another important aspect is to provide the policy of “transparency” of bioequivalence research results, which contributes to the use of better drugs. Aim. To analyze domestic and global approaches to the organization of the bioequivalence research and provide the policy of “transparency” of their results. Materials and methods. A comparative analysis of approaches to drug registration, requirements for generic drugs and bioequivalence studies and ways to provide the policy of “transparency” of their results in Ukraine, the United States and the European Union was conducted. Results. The analysis has revealed that the methods of registration of drugs in Ukraine, the United States and the EU are the same. Approaches to providing the “transparency” of the results of bioequivalence studies differ since in Ukraine the publication of such information is not mandatory and is at the discretion of pharmaceutical manufacturers. Conclusions. Domestic regulatory requirements for assessing generic drugs are harmonized with the world ones. Today, there is a need to introduce a mandatory requirement for the publication of bioequivalence studies, and it will contribute to providing an effective “transparency” policy.

Author(s):  
Attarid Awadh Abdulhameed

Ukrainia Remains of huge importance to Russian Strategy because of its Strategic importance. For being a privileged Postion in new Eurasia, without its existence there would be no logical resons for eastward Expansion by European Powers.  As well as in Connection with the progress of Ukrainian is no less important for the USA (VSD, NDI, CIA, or pentagon) and the European Union with all organs, and this is announced by John Kerry. There has always ben Russian Fear and Fear of any move by NATO or USA in the area that it poses a threat to  Russians national Security and its independent role and in funence  on its forces especially the Navy Forces. There for, the Crisis manyement was not Zero sum game, there are gains and offset losses, but Russia does not accept this and want a Zero Sun game because the USA. And European exteance is a Foot hold in Regin Which Russian sees as a threat to its national security and want to monopolize control in the strategic Qirim.


2019 ◽  
Vol 22 (2) ◽  
pp. 74-79
Author(s):  
Nargiza Sodikova ◽  
◽  
◽  

Important aspects of French foreign policy and national interests in the modern time,France's position in international security and the specifics of foreign affairs with the United States and the European Union are revealed in this article


2016 ◽  
pp. 26-46
Author(s):  
Marcin Jan Flotyński

The global financial crisis in 2007–2009 began a period of high volatility on the financial markets. Specifically, it caused an increased amplitude of fluctuations of the level of gross domestic products, the level of investment and consumption and exchange rates in particular countries. To address the adverse market circumstances, governments and central banks took actions in order to bolster the weakening global economy. The aim of this article is to present the anti-crisis actions in the United States and selected member states of the European Union, including Poland, and an assessment of their efficiency. The analysis conducted indicates that generally the actions taken in the United States in response to the crisis were faster and more adequate to the existing circumstances than in the European Union.


Author(s):  
Francesco Giumelli ◽  
Michal Onderco

Abstract While the current practice of the United Nations Security Council, the European Union, and the United States leans towards imposing only targeted sanctions in most of the cases, private actors often complain about inability to process financial transactions, ship goods, or deliver services in countries where sanctions targets are located. The impact of sanctions often ends up being widespread and indiscriminate because sanctions are implemented by for-profit actors. This article investigates how for-profit actors relate to the imposition of sanctions, how they reflect them in their decisions, and how they interact with the public authorities. The findings of our research show that for-profit actors, with the possible exception of the largest multinationals, do not engage with public authorities before the imposition of sanctions. The behaviour of for-profit actors in the implementation phase is in line with the assumption of firms and business as profit-maximisers. Weighting the profits from business against the costs of (non-)compliance and make the decisions that in their view maximise their profit. Indeed, de-risking seems to be the most common approach by the companies due to the uncertainties produced by the multiple and overlapping sanctions regimes imposed by the United Nations, the European Union, and the United States.


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