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.

Provides full coverage of Chinese Food and Drug Regulation Combines theory, policy, and practice into one discussion Usable by experts but also user-friendly for those with no experience

Autorentext

John Balzano is a lawyer in private practice in New York, who focuses on food, drug, medical device, cosmetic and animal product law and regulation, particularly with respect to China and other parts of Asia. He has been traveling to China and other parts of East Asia for nearly 24 years, where he has worked with various public and private stakeholders, including local practitioners, on policy issues and cases in these product areas. John speaks, reads, and writes Mandarin Chinese and Japanese.

Inhalt

1. Introduction and Methology.- 2. Agencies involved in China FDD Regulation.- 3. General Administrative Law Concepts and Enforcement Powers.- 4. Common Principles of China FDD Regulation.- 5. Pharmaceutical Regulation.- 6. Medical Device Regulation.- 7. Biosecurity and FDD Research and Development.- 8. Food and Special Food Regulation.- 9. Cosmetics Regulation.- 10. Advertising and Promotion for Regulated Products.