scholarly journals A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators Programme

2019 ◽  
Vol 22 ◽  
pp. 28-36 ◽  
Author(s):  
Alfredo Garcia Arieta ◽  
Craig Simon ◽  
Gustavo Mendes Lima Santos ◽  
Iván Omar Calderón Lojero ◽  
Zulema Rodríguez Martínez ◽  
...  
Keyword(s):  
South Africa ◽  
New Zealand ◽  
Immediate Release ◽  
The United States ◽  
Essential Medicines ◽  
Oral Dosage ◽  
Quantitative Composition ◽  
Limiting Factor ◽  
The European Union ◽  
Regulatory Requirements

The acceptance of foreign comparator products is the most limiting factor for the development and regulatory assessment of generic medicines marketed globally. Bioequivalence studies have to be repeated with the local comparator products of each jurisdiction because it is unknown if the comparators of the different countries are the same product, with the consequent duplication of efforts by regulators and industry alike. The regulatory requirements on the acceptability of foreign comparator products of oral dosage forms differ between countries participating in the Bioequivalence Working Group for Generics of the International Pharmaceutical Regulators Programme. Brazil, Colombia, the European Union member States, Japan, Mexico, South Korea and the United States only accept bioequivalence studies with their local comparator. In contrast, Australia, Canada, New Zealand, Singapore, South Africa, Switzerland and Taiwan accept studies with foreign comparators under certain conditions. Canada limits its use to highly soluble drugs with a wide therapeutic range in immediate release products. Australia requires a comparison of the quantitative composition. In contrast, there are fewer restrictions on the acceptance of foreign comparators in New Zealand, Singapore, South Africa, Switzerland and Taiwan. For the WHO Prequalification of Medicines and for developing generics of the essential medicines the WHO lists comparators from different countries. In conclusion, there is currently no consensus amongst regulators on the acceptability of foreign comparator products.

scholarly journals Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities

2021 ◽  
Vol 24 ◽  
pp. 548-562
Author(s):  
Matthias Shona Roost ◽  
Henrike Potthast ◽  
Chantal Walther ◽  
Alfredo García-Arieta ◽  
Ivana Abalos ◽  
...  
Keyword(s):  
Immediate Release ◽  
Dosage Forms ◽  
Oral Dosage ◽  
In Vitro Dissolution ◽  
Quantitative Composition ◽  
Modified Release ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms

This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less straightforward for modified release products than for immediate release products. There is consensus that modified release products should demonstrate bioequivalence not only in the fasted state but also in the fed state, but differences exist regarding the necessity of additional multiple dose studies. Fundamental differences between jurisdictions are revealed regarding requirements on the quantitative composition of different strengths and the differentiation of single and multiple unit dosage forms. Differences in terms of in vitro dissolution requirements are obvious, though these are mostly related to possible additional comparative investigations rather than regarding the need for product-specific methods. As with the requirements for immediate release products, harmonization of the various regulations for modified release products is highly desirable to conduct the appropriate studies from a scientific point of view, thus ensuring therapeutic equivalence.

International Report: Sludge management and related legislation

2002 ◽  
Vol 46 (4-5) ◽  
pp. 367-371 ◽  
Author(s):  
R. Leschber
Keyword(s):  
South Africa ◽  
European Union ◽  
United States Of America ◽  
Management Practices ◽  
The United States ◽  
Future Trends ◽  
The European Union ◽  
Sludge Management ◽  
International Report ◽  
America South

This report comprises the present sludge management practices with special view to agricultural utilization in the European Union and some accessing countries in eastern Europe in comparison with countries from Asia, the United States of America, South Africa and Australia. Information is given on the respective legislation and on future trends.

scholarly journals Balanced Investment Treaties and the BRICS

AJIL Unbound ◽  
2018 ◽  
Vol 112 ◽  
pp. 217-222 ◽  
Author(s):  
Congyan Cai
Keyword(s):  
South Africa ◽  
The United States ◽  
The European Union ◽  
Brics Countries ◽  
Investment Treaty ◽  
Wide Range ◽  
Cast Doubt ◽  
Investment Treaties ◽  
Emerging Powers ◽  
Bretton Woods Institutions

Brazil, Russia, India, China, and South Africa (the BRICS) have emerged as a new hub of power in international relations. They have begun to speak out jointly on a wide range of issues and to explore cooperating collectively. For instance, they strongly urge the Bretton Woods institutions to address their legitimacy deficits by transferring substantial voting power to emerging powers, and suggest that failure to do so will “run the risk of seeing [those institutions] fade into obsolescence.” The investment treaty regime may be another field in which they can exert influence, but the investment treaty policies of BRICS countries are diverging now more than ever. In particular, India and South Africa have taken significant measures, such as terminating investment treaties, that cast doubt on whether the BRICS can play a collective role in reforming such treaties. In this essay, I make two arguments. First, the recent investment treaty policies of some BRICS (India, South Africa, and to some extent Brazil) have shifted from one imbalanced approach that is too protective of foreign investors to another that is too protective of host states and is likely to be rejected by major powers such as the European Union, the United States, and China. Second, the BRICS together have the ability to craft approaches to investment treaties that encourage greater balance in the regime overall, including by remedying some of the defects inherent in the traditional investment treaties.

Britain and decolonization in an Era of Global Change

2017 ◽  
pp. 64-84
Author(s):  
Sarah Elizabeth Stockwell
Keyword(s):  
United States ◽  
South Africa ◽  
New Zealand ◽  
The United States ◽  
Great Power ◽  
Political Forces ◽  
Informal Empire ◽  
Colonial Empire ◽  
The Caribbean ◽  
Liberal Imperialism

This chapter considers processes of decolonization in Britain’s ‘empires’, incorporating discussion not just of the key dynamics and manifestations of decolonization in the colonial empire in India, Africa, the Caribbean and elsewhere, but also in Britain’s residual ‘informal’ empire in the Middle East, and in the ‘old’ Commonwealth countries of Australia, Canada, New Zealand and South Africa. The chapter argues that decolonization across these different contexts was driven by geo-political forces operating across the European empires, as the international order was reconfigured by two world wars, tilting power away from Britain and other European imperial powers. Stockwell nevertheless identifies elements of British imperial exceptionalism. She suggests that these were not to be found, as contemporaries liked to claim, in the form of a British liberal imperialism. Rather, Britain, which was at the centre of an empire larger than any other, retained a semblance of great power status, shaping British relations with the United States and Britain’s ambitions to exercise influence after empire.

Mining supply disruptions mask mounting demand fears

2020 ◽  
Keyword(s):  
United States ◽  
South Africa ◽  
New Zealand ◽  
Iron Ore ◽  
The United States ◽  
Middle Ground ◽  
Content Type ◽  
Supply Disruptions ◽  
Copper Mines ◽  
Southern Neighbour

Subject COVID-19-related disruptions to the mining supply chain. Significance The severity and length of COVID-19-related lockdowns has varied by country, but disruptions have quickly affected production. While West Africa, Russia and initially Mexico struggled to define a clear policy for mining, strict initial prohibition hit production in New Zealand, Peru, Argentina, South Africa, Ecuador and India in late March and into April. Spain, Australia, Chile, Quebec and Finland stuck to the middle ground, phasing policies in and out and permitting selected activity. Impacts Key plants, including iron ore mines in Australia and copper mines in Chile and the United States, are seeing little disruption so far. Mongolia, the first nation to close its borders with China, has also been the first to resume coal exports to its southern neighbour. Western Australia banned some fly-in, fly-out commuting arrangements to mines; similar such bans could persist elsewhere for months.

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
Keyword(s):  
United States ◽  
European Union ◽  
Generic Drugs ◽  
Low Cost ◽  
The United States ◽  
The European Union ◽  
Regulatory Requirements ◽  
Drug Registration ◽  
Pharmaceutical Manufacturers ◽  
Mandatory Requirement

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.

scholarly journals The Spanish and Portuguese Keyboards, the Best Options to Type in all Romance Languages for US-QWERTY Users

2021 ◽  
Author(s):  
Enrique Miguel Tébar Martínez
Keyword(s):  
United States ◽  
South Africa ◽  
New Zealand ◽  
The United States ◽  
Manual Dexterity ◽  
Romance Languages ◽  
European Languages ◽  
English Speaking ◽  
Western European ◽  
Keyboard Layout

While adequate for English-speaking users in the United States, as well as many Commonwealth countries and other English-speaking jurisdictions (e.g., Canada, Australia, New Zealand or South Africa among others), typing in Romance Languages (Spanish, French, Portuguese and Italian) by using a standard US-QWERTY Keyboard is not easy since it is not adapted to special characters such as accented vowels, tildes and cedillas or ligatures, used in Romance Languages. With regard to the International Layout, intended to enable access to the most common diacritics used in Western European Languages, the problem comes from the fact that accented vowels are spread throughout the Keyboard layout, and their uppercase versions need chord combinations which can require good manual dexterity. This paper will analyze how the Spanish or Portuguese Keyboards are the best options for these users since they are QWERTY-based and the most compatible ones for the different character sets in Spanish, French, Portuguese and Italian Languages.

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