scholarly journals EXPERTISE AND REGISTRATION OF ORPHAN MEDICINAL PREPARATIONS

2021 ◽  
Vol 91 (1) ◽  
pp. 20-35
Author(s):  
A. A. Kuhach ◽  
V. V. Kuhach
Keyword(s):  
European Union ◽  
Rare Diseases ◽  
The United States ◽  
Wide Distribution ◽  
Kyrgyz Republic ◽  
The European Union ◽  
Medicinal Preparations ◽  
Number Of Patients ◽  
The World ◽  
The Usa

The purpose of the study is to analyze examination and registration of orphan medicinal preparations in different countries of the world. Methods of description, comparison, grouping and analysis were used in the study. Great importance of the problem of orphan medicinal preparations manufacture and access to the market associated with a large number of rare diseases (7000-8000), their wide distribution in various regions of the world (up to 8% of the population), high cost of development and difficulty in conducting clinical trials is marked. It is shown that criteria for classifying diseases as orphan ones are their prevalence among the population as well as total number of patients in a particular country. Orphan medicinal preparations are those intended to treat rare diseases; in a number of countries (the USA and the European Union) the criterion for orphan medicinal preparations is its unprofitableness for the manufacturer. In the United States, the European Union and Japan special subdivisions for the registration of orphan medicinal preparations have been established in the structure of regulatory authorities. In order to stimulate the orphan medicinal preparations manufacture in the USA, the European Union, Australia and Japan manufacturers are given financial resources for the development and research, tax privileges, discounts and consultations with the specialists are provided during registration. Restructuring technology is widely used in the development of orphan medicinal preparations in the US and Singapore. It has been established that in order to increase accessibility for the population in different countries various accelerated procedures to give access to orphan medicinal preparations to the market are used. The terms of market exclusivity are stated: in Australia - 5 years, in the USA - 7 years, in Japan and the European Union - 10 years. It is determined that there are lists of orphan diseases (from 41 in the Kyrgyz Republic to 262 in the Russian Federation) and (or) orphan medicinal preparations approved in all the EAEU countries; accelerated registration procedures are provided; import of unregistered orphan medicinal preparations is allowed.

STRATEGIES OF MAIN ACTORS OF WORLD POLICY REGARDING THE MIDDLE EAST AND MODERN SYRIA(ON THE EXAMPLE OF THE USA AND THE EUROPEAN UNION)

2019 ◽  
pp. 316-322
Author(s):  
M. HADDAD
Keyword(s):  
United States ◽  
European Union ◽  
Middle East ◽  
The United States ◽  
The European Union ◽  
East Region ◽  
The World ◽  
The Usa ◽  
Middle East Region ◽  
The Eu

The article is devoted to the study of foreign policy strategies of the main actors of the world politics, represented by the USA and the countries of the European Union, regarding the Middle East and the Syrian Arab Republic. The interest in this topic is explained by the particular attractiveness of the Middle East region for the above-mentioned actors, since it has significant economic and transport potential and a favorable geographical position, which opens up opportunities for establishing strong partnership trade and economic ties between the US and the EU on the one hand and Middle Eastern states on the other. At the same time, the Middle East, as a region of increased military-political and social tension, directly influences peace and security situation in the entire world, and because of that the most developed countries of the world seek to establish control over the internal politics in the Middle East and spread their influence on its territory. The author pays great attention to the study of factors that have contributed to the formation of certain US and EU foreign policy courses in respect of the entire Middle East and Syria in particular, and comes to the conclusion that all of them can conditionally be divided into several large groups that equally affect the development process strategies. Their comparison allowed us to establish that in general both the USA and the countries of the European Union have similar perspective goals and objectives, however, they use different methods and forms of implementing their strategies. This explains the difference in the results achieved: while the United States successfully implement their geopolitical aspirations and gradually strengthen their presence in the Middle East, the EU countries are faced with a number of problems that impede their participation in the current regional events. Nevertheless, despite the successes and failures, the importance of the Middle East region for both the United States and the EU is beyond doubt.

Russian Federation and the United States of America: geostrategic directions to manage the Ukrainian crisis

2019 ◽  
pp. 123
Author(s):  
Attarid Awadh Abdulhameed
Keyword(s):  
United States ◽  
European Union ◽  
National Security ◽  
Russian Federation ◽  
United States Of America ◽  
The United States ◽  
The European Union ◽  
The Usa ◽  
Ukrainian Crisis ◽  
Zero Sum

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.

Germany's relations with the United States and China from a strategic triangle perspective

2021 ◽  
Author(s):  
Sebastian Biba
Keyword(s):  
United States ◽  
European Union ◽  
The United States ◽  
Great Power ◽  
The European Union ◽  
Bilateral Relations ◽  
Puzzle Piece ◽  
The Us ◽  
The World ◽  
Angela Merkel

Abstract As the Sino-American Great Power competition continues to intensify, newly-elected US President Joe Biden's administration now seeks to enlist the support of its allies and partners around the world. As Europe's largest economy and a, if not the, leading voice within the European Union, Germany represents an important puzzle-piece for Biden. But Germany, at least under outgoing chancellor Angela Merkel, has been reluctant to take sides. It is against this backdrop that this article looks into Germany's past and present trilateral relationships with the US and China through the theoretical lens of the so-called strategic triangle approach. Applying this approach, the article seeks to trace and explain German behaviour, as well as to elucidate the opportunities and pitfalls that have come with it. The article demonstrates that Germany's recently gained position as a ‘pivot’ (two positive bilateral relationships) between the US and Chinese ‘wings’ (positive bilateral relations with Germany and negative bilateral relations with each other) is desirable from the perspective of the strategic triangle. At the same time, being pivot is also challenging and hard to maintain. Alternative options, such as entering a US–German ‘marriage’ directed against China, are also problematic. The article therefore concludes that Germany has tough decisions to take going forward.

scholarly journals Cooperation and Coopetition as a Tools Which Could Improve Leading Startups all over the World

2017 ◽  
Vol 11 (2) ◽  
pp. 228
Author(s):  
Aneta Ejsmont
Keyword(s):  
United States ◽  
The United States ◽  
Good News ◽  
The European Union ◽  
The United Kingdom ◽  
The World ◽  
The Usa ◽  
Leading Position ◽  
Foreign Sale ◽  
The Moment

Building own business is a long-term and laborious process. A person who leads a startup tries to start with building own business by taking first steps toward financial independence. Analyzing conditions in Poland, on average every second startup sells its services abroad, admittedly it is good news, although half of them do not export at all. Half of the startups which export their services and goods generates more than 50% of their revenues outside Poland. Very interesting is the fact that 60% of exporters have conducted their foreign sale since the moment of establishing their business. On which markets do they sell their services? It turns out that the most popular are markets in the European Union (54%), including the United Kingdom 14% and Germany 9%. Only about 25% of Polish startups exports their products and services to the United States. Taking the United States into consideration, in 2008 the USA lost their leading position in the number of startups which are newly created and achieving success in business. Currently in terms of the number of new startups the USA is on a quite distant place after Denmark, Finland, Sweden, Hungary, New Zealand, Israel or Italy. In short, more companies were closed than created, so it was, as a matter of fact, like in Poland. Therefore, the condition to improve the development of startups both from Poland and other countries all the world is to increase cooperation and coopetition.

European Union in Counter-Crisis Competition of Power Centers: Potential, Realities, Hopes

2013 ◽  
pp. 68-77
Author(s):  
K. Voronov
Keyword(s):  
European Union ◽  
Gdp Growth ◽  
The European Union ◽  
Historical Experience ◽  
The World ◽  
The Usa ◽  
Evolutionary Robustness ◽  
Power Centers ◽  
Macroeconomic Growth ◽  
The Eu

Despite the crisis, the economy of the European Union remains to be the largest in the world. The economic mechanism of the EU is rather differentiated. It has a great historical experience and possesses sufficient evolutionary robustness. Currently, the former relationships between the EU and the USA undergo substantial changes and new forms emerge. For both of them the greatest challenge is presented by China which in recent decades shows the solid rates of GDP growth. Supposedly, Chines economy will become the world largest on in the new future. Under such conditions the Old World has to conduct a persistent search for new sources of its successful macroeconomic growth.

Sustainable Agriculture The United States versus the European Union

2010 ◽  
Vol 1 (4) ◽  
pp. 26-31 ◽  
Author(s):  
Carson H. Varner ◽  
Katrin C. Varner
Keyword(s):  
United States ◽  
European Union ◽  
Genetically Modified Crops ◽  
The United States ◽  
World Population ◽  
The European Union ◽  
Sustainability Issue ◽  
The World ◽  
Two Sides

This paper examines developing issues and attitudes that unite and divide the United States and the European Union as the discussion and regulation of agriculture evolves. While some terms, such as “organic,” are defined in law in both the United States and European Union, the increasingly used “sustainability” is an evolving concept. The main sustainability issue is how to provide food and fiber for a rapidly growing world population. In this context, the role of biotechnology is questioned. Americans tend to favor what are sometimes called genetically modified crops, while Europeans remain cautious. Europeans lean more toward organic farming, while Americans assert that much of the world will starve if organic methods are required. This paper reviews the directions that the discussion of these issues is taking and will show areas of agreement and where the two sides diverge.

scholarly journals Impact of Russian Non-Tariff Measures on European Union Agricultural Exports

2016 ◽  
Vol 8 (5) ◽  
pp. 39 ◽  
Author(s):  
Ye Mingque ◽  
Alena Slisava
Keyword(s):  
European Union ◽  
Gravity Model ◽  
Agricultural Products ◽  
The Other ◽  
Kyrgyz Republic ◽  
The European Union ◽  
Domestic Production ◽  
Agricultural Exports ◽  
The Usa ◽  
The Eu

<p>Nowadays non-tariff measures become more and more widely used. Russia is one of world largest importers of agri-products. In order to protect domestic production different non-tariff measures (NTMs) are used, which create difficulties for the exporters because NTMs are strict, changeable and difficult to deal with. This article analyses Russian non-tariff measures and their influence on the European Union exports of agri-products by using gravity model. The results show that Russian trade resistance is weaker for EU agricultural products exporters than for the USA exporters but stronger than for Chinese agricultural products exporters. The results do not prove that Russia’s NTMs have bigger impact on the EU exports than on the other countries’ exports such as India, Kyrgyz Republic, and the Ukraine. The NTM of such countries as China and Mexico also have much greater influence on the EU exports of agri-products than Russian NTMs.</p>

scholarly journals Asia Treads the Nuclear Path, Unaware That Self-Assured Destruction Would Result from Nuclear War

2017 ◽  
Vol 76 (2) ◽  
pp. 437-456 ◽  
Author(s):  
Owen B. Toon ◽  
Alan Robock ◽  
Michael Mills ◽  
Lili Xia
Keyword(s):  
European Union ◽  
Nuclear Weapons ◽  
North Korea ◽  
The United States ◽  
United Nations Security Council ◽  
The European Union ◽  
Nuclear War ◽  
The Pacific ◽  
The World ◽  
The Pacific Ocean

Of the nine countries known to have nuclear weapons, six are located in Asia and another, the United States, borders the Pacific Ocean. Russia and China were the first Asian nations with nuclear weapons, followed by Israel, India, Pakistan, and North Korea. Most of the world's nuclear powers are reducing their arsenals or maintaining them at historic levels, but several of those in Asia—India, Pakistan, and North Korea—continue to pursue relentless and expensive programs of nuclear weapons development and production. Hopefully, the nuclear agreement reached in July 2015 between Iran, the European Union, and the five permanent members of the United Nations Security Council will be a step toward eliminating nuclear weapons throughout Asia and the rest of the world. As we will discuss below, any country possessing a nuclear arsenal is on a path leading toward self-assured destruction, and is a threat to people everywhere on Earth.

scholarly journals 5G and its Implications in the Economic Relations between China and European Countries, with a Special Focus on Italy

2020 ◽  
pp. 1-10
Author(s):  
Melania Petrillo
Keyword(s):  
United States ◽  
European Union ◽  
The United States ◽  
European Countries ◽  
Special Focus ◽  
The European Union ◽  
Economic Relations ◽  
5G Network ◽  
The Usa ◽  
State Of Affairs

The economic relations between China and the European countries are tightened by an intensive interdependence in different sectors, mainly trades and services, but decades of successful relations could be affected by the pressure risen around the development of the 5G network. Recently, the development of the technology of the future, 5G network, is having a certain effect on the relations among those countries that joined the race for the leading global position. The major players in this geopolitical, technological, and economic affair are China and the USA, therefore, Europe plays an important role as well. These occurrences may increase not only the strategic suppleness of powers like China, India, the United States, and the European Union, but also the weight of nourishing alignments and fruitful partnerships. This research takes into consideration two fundamental elements to analyze this state of affairs: the economic interdependence between China and the European countries, and the protection of cybersecurity.

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