Matthews B R
Alcon Laboratories (UK) Limited, Hemel Hempstead, England.
Drug Dev Ind Pharm. 1999 Jul;25(7):831-56. doi: 10.1081/ddc-100102245.
The stability data requirements for human pharmaceuticals in the European Community (EC) are based on a series of Directive and Regulation requirements and on a series of advisory guidelines that have been developed and adopted through the International Conference on Harmonization (ICH) procedures or, where there is no relevant ICH project, through the Committee for Proprietary Medicinal Products (CPMP). There are relevant requirements that cover new drugs and finished products containing them and also for existing active ingredients and products containing them. The sources of the relevant information and the data requirements are discussed and summarized.
欧洲共同体（EC）对人用药品的稳定性数据要求基于一系列指令和法规要求，以及通过国际协调会议（ICH）程序制定和采用的一系列咨询指南，或者在没有相关ICH项目的情况下，通过专利药品委员会（CPMP）制定和采用的指南。有一些相关要求涵盖新药和含有新药的成品，也适用于现有活性成分和含有这些活性成分的产品。本文讨论并总结了相关信息的来源和数据要求。
