China Food and Drug Law
China Food and Drug Law

Author: John C. Balzano

Publisher: Springer

Published: 2024-08-17

Total Pages: 0

ISBN-13: 9783031619007

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This book is an analysis of policy and law governing the development, approval, manufacture, distribution, marketing and post-market surveillance of human drugs, medical devices, foods and cosmetics in Mainland China (“China FDD Regulation”). It analyzes the policy and general principles behind China FDD Regulation, including the history and jurisdiction of the central and local agencies that administer the laws and regulations, the administrative law structure in which these agencies operate, and other aspects of FDD Regulation interpretation and enforcement. Although it describes practice in China, this book is written in the comparative perspective (i.e., sensitive to assumptions made by those who are steeped in FDD Regulation in the U.S., Japan, and the EU). It includes one chapter on each regulatory space (drugs, medical devices, cosmetics, and food) organized by the lifecycle of products. It also covers subcategories of products, such as vaccines, radiopharmaceuticals, and in vitro diagnostic medical devices. The book includes specialty chapters on areas that are common to multiple types of regulated products, such as biosecurity and advertising. It is the first English language book of its kind, and it can serve as a resource for those in the FDD law and regulatory field to understand the mechanics of developing and marketing products, but also with insights for businesspeople and others, who are developing China-strategies.

Chinese Food Law
Chinese Food Law

Author: Jasmin Buijs

Publisher: BRILL

Published: 2023-08-14

Total Pages: 279

ISBN-13: 9086869416

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The People's Republic of China is one of the largest importers and exporters of food products in the world. After the melamine crisis fundamentally challenged its food legal infrastructure, the PRC now boasts one of the most modern systems of food law in the world. This makes Chinese food law very interesting for its own sake but also as a source for comparison and inspiration. This book aims to make Chinese food law accessible to a non-Chinese audience. The book follows the same legal-systematic approach that has proven its usefulness in explaining EU food law in the EU Food Law Handbook. Topics discussed include the history of Chinese food law, general principles, the institutional framework, the difference between food and edible agricultural products, the homology of food and medicine, authorization requirements for food additives, novel food materials, health foods, food for special medical purposes and infant formula, genetically modified organisms, maximum limits for residues and other contaminants, process requirements to prevent and deal with food safety incidents, labelling requirements including nutrition and health claims and food law enforcement. Where appropriate we have taken into account the perspective of businesses wishing to export to China. You don't need a background related to food, to law or to China to enjoy this book. Readers may include students or researchers with an interest in Chinese or comparative food law, but also public authorities, NGOs or food businesses who wish to better understand or to take inspiration from food law in the People's Republic of China.

Imports from China and Food Safety Issues
Imports from China and Food Safety Issues

Author: Fred Gale

Publisher: DIANE Publishing

Published: 2010-02

Total Pages: 37

ISBN-13: 1437921361

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The FDA¿s increased attention to food imports from China is an indicator of safety concerns as imported food becomes more common in the U.S. Addressing safety risks associated with these imports is difficult because of the vast array of products from China, China¿s weak enforcement of food safety standards, its heavy use of ag. chem., and environ. pollution. FDA refusals of food shipments from China suggest recurring problems with ¿filth,¿ unsafe additives, labeling, and vet. drug residues in fish and shellfish. Chinese authorities try to control food export safety by certifying exporters and the farms that supply them. However, monitoring such a wide range of products for the different hazards is a difficult challenge for Chinese and U.S. officials. Ill.

China Rx
China Rx

Author: Rosemary Gibson

Publisher: Prometheus Books

Published: 2018

Total Pages: 306

ISBN-13: 1633883817

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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.

An Overview of FDA Regulated Products
An Overview of FDA Regulated Products

Author: Eunjoo Pacifici

Publisher: Academic Press

Published: 2018-06-13

Total Pages: 292

ISBN-13: 0128111569

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Today’s challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations

Approaching China's Pharmaceutical Market
Approaching China's Pharmaceutical Market

Author: Ming Q. Lu

Publisher: Springer

Published: 2015-07-30

Total Pages: 657

ISBN-13: 3319155768

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​This authoritative volume examines the major laws, regulations and guidelines related to pharmaceutical product development in China. With a focus on patent, clinical and registration strategies, the book helps Western companies introduce their clinical drugs to the Chinese market, determine a strategic path and bridge the gap for regulatory and legal differences between China and the Western world. For a better understanding of the drug registration process, it explores the differences between the China Food and Drug Administration (CFDA)—including its regulations and registration procedures—and those of the Western world. The volume discusses disparities between China's application requirements compared to Western standards to make it easier for companies to prepare their application packages. It also provides detailed commentary on CFDA guidelines in reference to clinical trial (IND) and market application (NDA) requirements. Overall, this book offers guidance for Western companies aspiring to expand into China’s pharmaceutical market in hopes that they may gain a fundamental understanding of its rules and complexities in order to ensure a smooth transition and prevent future issues.