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Author:
Publisher: Washington Business Information
ISBN: 9781932074185
Category : Drug control
Languages : en
Pages : 328
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Book Description
Author:
Publisher: Washington Business Information
ISBN: 9781932074185
Category : Drug control
Languages : en
Pages : 328
Get Book Here
Book Description
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309498635
Category : Medical
Languages : en
Pages : 169
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Book Description
Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Author: U. S. Customs and Border Protection
Publisher:
ISBN: 9781304100061
Category : Education
Languages : en
Pages : 0
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Book Description
Explains process of importing goods into the U.S., including informed compliance, invoices, duty assessments, classification and value, marking requirements, etc.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 924156301X
Category : Medical
Languages : en
Pages : 1526
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Book Description
The International Pharmacopoeia contains a collection of recommended methods for analysis and quality specifications for pharmaceutical substances, excipients and products. This new edition consolidates the texts of the five separate volumes of the third edition and includes new monographs for antiretroviral substances (didanosine, indinavir sulfate, nelfinavir mesilate, nevirapine, ritonavir, saquinovir, and saquinovir mesilate) adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2004. It includes some additions and amendments to the general notices of the Pharmacopoeia, as well as some changes to its layout and format. Volume one contains monographs for pharmaceutical substances A to O and the General Notices; and volume two contains monographs for pharmaceutical substances P to Z, together with those for dosage forms and radiopharmaceutical preparations, the methods of analysis and reagents.
Author: Rosemary Gibson
Publisher: Prometheus Books
ISBN: 1633883817
Category : Business & Economics
Languages : en
Pages : 306
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Book Description
Millions of Americans are taking prescription drugs made in China and don't know it-- and pharmaceutical companies are not eager to tell them. This probing book examines the implications for the quality and availability of vital medicines for consumers. Several decades ago, penicillin, vitamin C, and many other prescription and over-the-counter products were manufactured in the United States. But with the rise of globalization, antibiotics, antidepressants, birth control pills, blood pressure medicines, cancer drugs, among many others are made in China and sold in the United States. China's biggest impact on the US drug supply is making essential ingredients for thousands of medicines found in American homes and used in hospital intensive care units and operating rooms. The authors convincingly argue that there are at least two major problems with this scenario. First, it is inherently risky for the United States to become dependent on any one country as a source for vital medicines, especially given the uncertainties of geopolitics. For example, if an altercation in the South China Sea causes military personnel to be wounded, doctors may rely upon medicines with essential ingredients made by the adversary. Second, lapses in safety standards and quality control in Chinese manufacturing are a risk. Citing the concerns of FDA officials and insiders within the pharmaceutical industry, the authors document incidents of illness and death caused by contaminated medications that prompted reform. This is a disturbing, well-researched book and a wake-up call for improving the current system of drug supply and manufacturing.
Author:
Publisher: National Academies
ISBN:
Category : Business & Economics
Languages : en
Pages : 208
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Book Description
Author: U. s. Government Printing Office
Publisher: Government Printing Office
ISBN: 9780160907210
Category : Law
Languages : en
Pages : 372
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Book Description
Author:
Publisher:
ISBN:
Category : Foreign trade regulation
Languages : en
Pages : 16
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Book Description
Author: Ellen F. M. 't Hoen
Publisher:
ISBN: 9789079700066
Category : Agreement on Trade-Related Aspects of Intellectual Property Rights
Languages : en
Pages : 136
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Book Description
In The Global Politics of Pharmaceutical Monopoly Power, researcher and global advocate Ellen 't Hoen explains how new global rules for pharmaceutical patenting impact access to medicines in the developing world. The book gives an account of the current debates on intellectual property, access to medicines, and medical innovation, and provides historical context that explains how the current system emerged. This book supports major policy changes in the management of pharmaceutical patents and the way medical innovation is financed in order to protect public health and, in particular, promote access to essential medicines for all. The Open Society Institute provided support to translate this report into Russian.
Author: United States. Congress. Senate. Committee on Labor and Human Resources
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 360
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Book Description
