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欧洲药品基本文件对有效成份化学的要求本文件是根据欧洲经济共同体（ＥＥＣ）申请新药品进入市场的指令７５／３１８／ＥＥＣ以及９１／８５２／ＥＥＣ文件附件Ｃ篇第一部分所拟定的指导书。１ 引言本指导书的目标是提出为控制在某一药品中首次使用的新活性成份所要求上...
European Medicines Essential Documentation Requirements for Active Ingredient Chemistry This document is based on instructions developed by the European Economic Community (EEC) for Directing New Drugs to Market 75/318 / EEC and Part I of Annex C, Document 91/852 / EEC. 1 Introduction The purpose of this guideline is to propose the requirements for the control of new active ingredients for the first time in a pharmaceutical product ...