OBJECTIVES: This article makes a review on the historical evolution of China’s drug regulatory system and provides some reflections and policy implications for the reform of the present system. METHODS: This study is based on literature review and publicly available data by searching electronic databases and official web pages of Chinese government on the internet. RESULTS: China’s drug regulatory system has experienced complicated process of evolution. During the period of planned economy China had no independent drug regulatory system. The way to control the quality and safety of pharmaceutical products was to take full control of every aspect of the pharmaceutical industry. After the reform policy in 1978, both the governmental regulators and the regulated pharmaceutical industry became development-oriented. The effective control of the quality and safety of pharmaceutical products became a serious problem. In order to reverse the situation China tried to establish an independent drug regulatory system. CONCLUSIONS: Because of path dependence it is very difficult to turn the drug regulatory system from the system of unification of the regulators and the regulated into an independent system. The introduction of a formally independent regulatory system has improved the regulator's motive to supervise the quality and safety of drugs to some extent. But many impediment factors still exist both inside and outside China’s drug regulatory system. The great difficulties to establish an effective drug regulatory system China experienced during the past 10 years proved that the old way in which the government regulatory agencies operate is very difficult to shake. The policy maker should fully understand the impact of the previous system and make a long and Coordinative effort. The best way to establish a good independent drug regulatory system has to be a gradual rather than a radical reform.