论中美两国在药品监督管理方面的差异性

Discussion on the Difference Between FDA and SDA in Drug Administration

目的 :提升我国药品监督管理工作水平。方法 :比较我国食品药品监督管理局 (SFDA)与美国食品与药品管理局 (FDA)在药品监管体制、管理和培训机制等方面的差异。结果与结论 :药品监管体制中的“中央集权制”和“地方分权制”各有利弊 ,关键在于做到“趋利避害”。SFDA应着重建立药品监管的预警、警示制度 ,加强高水准药品监管人员培训 。

OBJECTIVE:To improve the level of drug administration in China METHODS:To compare and analyse the differences in system,administration,education and practice between FDA and SDA RESULTS & CONCLUSION:There are 'centralization of state power' and 'decentralized management' in drug administration system For either system has its advantages and disadvantages,key point is to seek advantages and avoid disadvantages SDA should establish the early warning system,enhance the training of high quality personnel for drug administration and formulate the working rules of drug administration