Common General Principles of China Food and Drug Regulation

Despite the significant differences in risk levels and regulatory approaches in the different food, drug, medical device, and cosmetic spaces, it is possible to discern common principles and trends that pervade them. This chapter provides an introduction to these common elements to assist with understanding the specific analyses for each area that follow. By looking at the commonalities, it is possible to begin to understand China’s overall FDD regulatory policy. In addition to the impact of broader administrative trends, each of the FDD areas has had an influence on the others. For example, the focus on the liability of individuals (discussed above) in the food space has influenced later revisions in the drug, device, and cosmetic spaces. These general principles also relate to many of the trends described in the Introduction, including decreasing and streamlining onerous pre-market approvals, adopting a regulatory approach that looks at safety, quality, and effectiveness over the product’s lifecycle, enhancing post-market safety controls, and promoting innovation.