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Considerations on Administration of Registration and Technical Evaluation of New Chinese Drugs Techuical
关于目前中药新药注册管理及技术审评思考

Keywords: new Chinese drugs,technical evaluation,control of new drugs,problem
中药新药
,技术审评,新药管理

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Abstract:

In view of Some principal problems emerging from the present research and production of new Chinese drugs, this article proposes that the requirements of evaluation of new drugs must be further improved and the system of evaluation personnel be established, and puts forward such viewpoints and proposals as the redefinition of the conception of new drugs, which is extended from the policies for the control of new drugs, the development of new drugs belonging to the fifth class of traditional Chinese medicine and the establishment of an office in charge of the re-evaluation and re-experiment of new drugs' pharmacology. Besides, it expounds, in the light of the present situation in the research and production of new drugs, some problems which are worth paying attention to in the evaluation of new drugs.

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