China Food and Drug Law: Policy, Practice, and Future Directions
暫譯: 中國食品藥品法：政策、實務與未來方向
Balzano, John C.
商品描述
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.
商品描述(中文翻譯)
本書分析了中國大陸（「中國FDD法規」）在人用藥物、醫療器械、食品和化妝品的開發、批准、生產、分銷、行銷及上市後監管方面的政策和法律。
本書分析了中國FDD法規背後的政策和一般原則，包括管理這些法律和法規的中央及地方機構的歷史和管轄權、這些機構運作的行政法結構，以及FDD法規解釋和執行的其他方面。雖然本書描述了中國的實踐，但它是以比較的視角撰寫的（即對於那些深耕於美國、日本和歐盟FDD法規的人所做的假設保持敏感）。
本書包含針對每個監管領域（藥物、醫療器械、化妝品和食品）的章節，並根據產品的生命周期進行組織。它還涵蓋了產品的子類別，如疫苗、放射性藥物和體外診斷醫療器械。本書包括針對多種類型受監管產品的共同領域的專門章節，如生物安全和廣告。
這是首本此類的英文書籍，可以作為FDD法律和監管領域人士的資源，以了解開發和行銷產品的機制，同時也為正在制定中國策略的商業人士和其他人提供見解。
作者簡介
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.
作者簡介(中文翻譯)
約翰·巴爾扎諾是一位在紐約的私人執業律師，專注於食品、藥品、醫療器械、化妝品和動物產品的法律與法規，特別是針對中國及其他亞洲地區。他已經在中國和東亞其他地區旅行近24年，期間與各種公共和私人利益相關者，包括當地從業者，合作處理這些產品領域的政策問題和案件。約翰能夠說、讀和寫普通話和日語。
