Law for Professionals

This book will take the reader through the past, the present, and into the future of the flagship institution of the international customs community: the World Customs Organization (WCO).

The purpose is to present to the reader, in a comprehensive, orderly, and synthetic manner, the enormous contributions that this prestigious and recognized institution has been making to the secure growth of global international trade.

In the development of the text, special consideration has been given to the relevant instruments in day-to-day customs work, which constitute the bases of the WCO (the Harmonized System Convention, the Revised Kyoto Convention, and the SAFE Framework of Standards, among many others), as well as those issues that are currently of specific interest to the global customs community (cross-border e-commerce, trade facilitation, and authorized economic operator, to mention but a few), trying to reconcile the various practical aspects of customs operationswith their theoretical underpinnings.

In the final part, the book turns to the future of customs, analyzing the most pressing challenges presented by technological advances, including the Internet of Things, artificial intelligence, 3D printing, and blockchain.

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.