中国的药品注册管理制度自新中国成立以来,经历了初始、形成和完善三个阶段。特别是1985年开始实施《药品管理法》以来,药品审评机制改革不断深入。2001年12月1日开始实施修订的《药品管理法》和我国加入WTO的新形势,对中国的药品注册管理制度又带来新的机遇与挑战。本文回顾了中国药品注册管理制度经历了三个阶段历程,就中国加入WTO以后对药品注册的影响进行了认真分析,提出了改革中国药品注册制度新的思路。

The system of drug registration and management in China has gone through the three stages of initiation, formation and completion since the founding of new China, and since 1985 when the Law of Drug Management began to be enforced in particular, the reform of examination and evaluation mechanisms of drugs has ever gone deeply. Owing to the implementation of the revised Law of Drug Management, which began from December 1,2001 and to the new situation emerging after China admitted into WTO, new opportunities and challenge will come up before the system of drug registration and management of the country. After looking back the said three stages, this article seriously analyzes the impact of China's admission into WTO on the registration of drugs and proposes new considerations concerning the reform of the system of drug registration and management in China.