Comparison of generic drug registration strategies between health Canada and Gulf Cooperation Council

2021 ◽  
pp. 174113432110299
Author(s):  
Narayana R Charyulu ◽  
Anoop V Narayanan ◽  
Amitha Shetty
Keyword(s):  
Generic Drug ◽  
United States Of America ◽  
The United States ◽  
Gulf Cooperation Council ◽  
Pharmaceutical Manufacturer ◽  
Drug Products ◽  
Drug Registration ◽  
Product Regulation ◽  
Market Product ◽  
Health Canada

Recently, generic drug products have played an increasingly important role in the health care system globally, especially in the developing world, as they provide for an effective and more affordable alternative for healthcare professional. Generic drug products are proven therapeutically equivalent to the corresponding innovator’s product, and hence can be substituted in clinical practice. The Gulf Cooperation Council’s pharmaceutical market is known to be semi-regulated market when compared with Health Canada and the United States of America drug regulatory market. Product regulation in Gulf Cooperation Council and Health Canada are challenging task in comparison to EU and USA. This study aimed to understand the generic drug registration comparison of Health Canada and Gulf Cooperation Council’s. The aim of this study was achieved by review of the Health Canada and Gulf Cooperation council guidelines and publications. Health Canada and Gulf Cooperation council follows Common Technical Document format and also emphasizes on safety, quality and efficacy of the drug. In summary Gulf Cooperation council and Health Canada offers lucrative market for Indian pharmaceutical manufacturer and the process of registration has been simplified by centralized procedure.

scholarly journals Probiotic Products in Canada with Clinical Evidence: What Can Gastroenterologists Recommend?

2008 ◽  
Vol 22 (2) ◽  
pp. 169-175 ◽  
Author(s):  
Gregor Reid ◽  
Kingsley Anukam ◽  
Tara Koyama
Keyword(s):  
United States Of America ◽  
Clinical Evidence ◽  
Health Benefit ◽  
The United States ◽  
World Health ◽  
Therapeutic Effects ◽  
The Us ◽  
Health Organization ◽  
Health Canada

Probiotics, defined as ‘live microorganisms, which when administered in adequate amounts, confer a health benefit on the host’, are finally becoming an option for gastroenterologists in Canada, after being available for many years in Japan, Europe and the United States of America. Unfortunately, Health Canada and the US Food and Drug Administration have not controlled the use of the term ‘probiotic’ or put into place United Nations and World Health Organization guidelines. The net result is that a host of products called ‘probiotics’ are available but are not truly probiotic. The aim of the present review was to discuss the rationale for probiotics in gastroenterology, and specifically examine which products are options for physicians in Canada, and which ones patients might be using. It is hoped that by clarifying what probiotics are, and the strengths and limitations of their use, specialists will be better placed to make recommendations on the role of these products in patient care. In due course, more clinically documented probiotics will emerge, some with therapeutic effects based on a better understanding of disease processes.

Comparison of regulatory dossier requirements for marketing authorization of generic solid dosage forms in the United States and Europe: A review

2021 ◽  
pp. 174113432110007
Author(s):  
Lovely Joylein ◽  
Bishop Adhikari ◽  
Megha Chellath Kottayi ◽  
GS Ravi ◽  
Akhilesh Dubey
Keyword(s):  
Generic Drug ◽  
Generic Drugs ◽  
The United States ◽  
Economic Benefits ◽  
Dosage Forms ◽  
Regulatory Requirements ◽  
Solid Dosage Forms ◽  
Drug Products ◽  
Solid Dosage ◽  
Pharmaceutical Manufacturers

Pharmaceutical solid dosage forms are categorized into several types based on the purpose, usage, and route of administration. Some examples of frequently available solid dosage forms include tablets, capsules, lozenges, powders, and granules. A generic drug is one of usually intending to be interchangeable with the innovator product, thereby making it essential for them to mimic the innovator drug concerning their safety and efficacy profiles. The essential concept of making a generic drug available hinges on its economic benefits towards the patient population as well as its feasibility in the development of benefits the pharmaceutical companies. Additionally, generic drugs expand the market of a particular API, thereby ensuring that an adequate number of medications are made available to cater to the needs of every patient and further preventing any issues arising out of drug shortages. The USFDA and the EMA, being two of the leading regulatory agencies across the globe, have long been associated with the development and drafting of regulations about the approval of generic drug products. A firm understanding of the regulatory requirements associated with the preparation of a generic drug dossier will aid pharmaceutical manufacturers in attaining favourable outcomes when desiring multicounty submissions, thereby ensuring a smooth review process without any substantial delays.

scholarly journals JORDANIAN FOREIGN POLICY TOWARDS THE COUNTRIES OF THE GULF COOPERATION COUNCIL (1999-2019)

2019 ◽  
pp. 52-65
Author(s):  
Saddoon N. Al-Majali
Keyword(s):  
United States ◽  
Foreign Policy ◽  
United States Of America ◽  
The United States ◽  
Gulf Cooperation Council ◽  
Security Cooperation ◽  
Gulf Crisis

The study aimed to research the Jordanian foreign policy towards the Gulf Cooperation Council states during the period 1999-2019, as this period is an extension of the previous stages, as during which Jordanian relations with the countries of the Gulf Cooperation Council were affected as a result of the second Gulf crisis 1990, and the events of September 2001, and what followed in light of the war on Iraq and its occupation by the United States of America, where the United States emerged as a unipolar force that dominates the world.The study showed that Jordanian foreign policy towards the Gulf Cooperation Council countries was affected by regional and international changes, as relations between Jordan and the countries of the Gulf Cooperation Council were characterized by apathy and approached isolation as a result of Iraq’s occupation of Kuwait, but Jordanian relations with the Gulf Cooperation Council countries improved, as a result of The multiple visits made by King Abdullah II after he assumed power in 1999, to the countries of the Gulf Cooperation Council, as Jordan's geopolitical position contributes to enhancing security and stability for the countries of the Council in exchange for Israeli expansionist ambitions, because Jordan looks at its security cooperation with the Gulf Cooperation Council (GCC) in the framework of the imperatives of mutual security, which posed this perspective as one of the dimensions in the Gulf of Jordan's foreign policy, which has not changed even in periods of Arab division, or during the boycott Cooperation Council (GCC) to Jordan.

Thinking About Scots Law

1996 ◽  
Vol 1 (1) ◽  
pp. 3-24 ◽  
Author(s):  
Alan Rodger
Keyword(s):  
United States ◽  
Nineteenth Century ◽  
British Empire ◽  
United States Of America ◽  
Case Law ◽  
The United States ◽  
Memorial Lecture ◽  
University Of Edinburgh ◽  
The University

This article is the revised text of the first W A Wilson Memorial Lecture, given in the Playfair Library, Old College, in the University of Edinburgh, on 17 May 1995. It considers various visions of Scots law as a whole, arguing that it is now a system based as much upon case law and precedent as upon principle, and that its departure from the Civilian tradition in the nineteenth century was part of a general European trend. An additional factor shaping the attitudes of Scots lawyers from the later nineteenth century on was a tendency to see themselves as part of a larger Englishspeaking family of lawyers within the British Empire and the United States of America.

Off to a bad start: John Adams’s tussle over titles

2008 ◽  
Vol 4 ◽  
Author(s):  
James C Alexander
Keyword(s):  
United States ◽  
United States Of America ◽  
Vice President ◽  
The United States ◽  
John Adams ◽  
The Press ◽  
First Session

From the first days, of the first session, of the first Congress of the United States, the Senate was consumed by an issue that would do immense and lasting political harm to the sitting vice president, John Adams. The issue was a seemingly unimportant one: titles. Adams had strong opinions on what constituted a proper title for important officers of government and, either because he was unconcerned or unaware of the damage it would cause, placed himself in the middle of the brewing dispute. Adams hoped the president would be referred to as, “His highness, the President of the United States of America, and Protector of the Rights of the Same.” The suggestion enraged many, amused some, and was supported by few. He lost the fight over titles and made fast enemies with several of the Senators he was constitutionally obligated to preside over. Adams was savaged in the press, derided in the Senate and denounced by one of his oldest and closest friends. Not simply an isolated incident of political tone-deafness, this event set the stage for the campaign against Adams as a monarchist and provided further proof of his being woefully out of touch.

Armed Violence in the Ideology of Contemporary Islamic Fundamentalism - Study models

2019 ◽  
Vol 2 (4) ◽  
pp. 237
Author(s):  
Laith Mzahim Khudair Kazem
Keyword(s):  
United States ◽  
United States Of America ◽  
The United States ◽  
The Other ◽  
Islamic Fundamentalism ◽  
Islamic Movements ◽  
Important Means ◽  
Armed Violence ◽  
Goals And Objectives ◽  
At Home

The armed violence of many radical Islamic movements is one of the most important means to achieve the goals and objectives of these movements. These movements have legitimized and legitimized these violent practices and constructed justification ideologies in order to justify their use for them both at home against governments or against the other Religiously, intellectually and even culturally, or abroad against countries that call them the term "unbelievers", especially the United States of America.

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