On The Improvement Of The Regulatory System For Drug Retail Enterprises

As the frontier of the integral drug regulation, regulation on Drug retail enterprises is an important part in drug regulation. Effective regulation plays a significant role in using drugs safely. Currently, Chinese regulatory mode of drug retail enterprises focuses on examination and approval, inspection and acceptance and issuing licenses and in daily supervision penalties are the principal when problems are found. Such a regulatory mode aiming at subsequent supervision of the counterpart is of no advantage in controlling drug safety all over China. The thesis is divided into four chapters. Chapter one is Chinese regulatory system of drug retail enterprises, simply introducing the regulatory means in China including the recognition of drug retail enterprises' business licenses, GSP certification and practitioner training. The second chapter refers to problems occurring under the abovementioned regulatory mode and analyzes practical problems brought about by business models and different regulatory systems and means. Chapter three indicates factors causing maladjustment and points out the defects of Chinese SFDA in the aspect of regulatory idea, organization establishment, laws and regulations of pharmaceutical affairs and regulatory means by the comparison with the advanced experience and practice of FDA of the United States. Chapter four discusses the countermeasures and proposes countermeasures and suggestions according to the aforesaid problems and the causes so as to further improve Chinese regulatory system of drug retail enterprises. By the previous discussion, the author plans to suggest that the regulatory idea against Chinese drug retail enterprises should be changed fundamentally and the guarantee of drug safety should be the the starting point of the all the work so as to play the role of drug regulatory authorities much better and more efficiently.