Law, Regulation and Guidance

Abstract

In comparison to western pharmaceutical regulations, China’s pharmaceutical legislation started much later in history. Because of these cultural, social, and economic discrepancies, foreign pharmaceutical companies hoping to introduce their drugs to the Chinese market have met many challenges and difficulties. China’s pharmaceutical laws and regulations are the legal norms that encompass unique social and economic relations during the national drug research and development, production, sale, use and monitoring stages. For multinational pharmaceutical companies that wish to enter the Chinese market, it is very important to know and understand the fundamental pharmaceutical legislations enacted in China. In this chapter, we’ll provide a brief outline of China’s pharmaceutical law and regulation development history, introduce the most important pharmaceutical laws with brief interpretations of the articles that are most relevant to overseas pharmaceutical companies, and the major regulations related to drug registration, quality management, and inspection. The corresponding guidances are listed and will be discussed in the corresponding independent chapters.