The China Food and Drug Administration (CFDA)

Abstract

China’s pharmaceutical regulatory environment and policies have constantly been changing in the past few years. In this chapter, we’ll provide a brief outline of the history of China’s regulatory system, including the stages of the State Drug Administration (SDA), the State Food and Drug Administration (SFDA), and the China Food and Drug Administration (CFDA. Among the topics considered are: the current China Food and Drug Administration (CFDA) structure and its function; the differences between China’s pharmaceutical regulatory environment and the environments of western countries; the state bases for clinical research of pharmaceutics and principle investigators; the differences between the CFDA and western regulatory agencies; and communication between Chinese regulatory agencies and regulatory information tracking. Practically speaking, the aforementioned topics are the most difficult ones for multinational pharmaceutical companies and pharmacy school students to understand. We hope this chapter may help the readers get a basic idea of China’s regulatory environment through the understanding of the CFDA structure and function and its differences from its counterparts in the western world.