为新药申报打下了良好的基础。
该平台由GRP实验管理系统、GLP新药申报系统和新药研发标准化流程管理系统组成。
This platform is composed by GRP experiment management system, GLP new drug application system and drug discovery standard workflow management system.
根据化学药品的五种类别，对申报资料中存在的问题进行了分析；提出了几点建议供新药申报者参考。
Problems existing in application dossier are analyzed, and the way to deal with the situation are offered based on 5 classes of chemical drugs.
目的：中药新药试行标准转正式标准申报资料中存在着多种问题。
Some problems exist in declared data with regard to tentative standards of new drugs of Traditional Chinese Medicine becoming official standards.
方法：统计2001～2006年四川省中药新药及按新药管理的中药申报注册的数据资料，并进行分析和评价。
METHODS: The data of the application and registration of TCM treated as new medicine and new TCM in Sichuan province from 2001 to 2006 were analyzed and evaluated statistically.
着重对新药研发、申报、审批环节造假行为法律制裁体系进行了考察。
They focus on the legal sanctions system against ACTS of forgery occurred during the process of the new drug research and development, declaration, and approval.
化学新药、中药新药的研究和申报。
Chemical drugs, traditional Chinese medicine research and the declaration of new drugs.
化学新药、中药新药的研究和申报。
Chemical drugs, traditional Chinese medicine research and the declaration of new drugs.
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