| 序号 | 名称 | 发布日期 | 链接 |
1 | Guideline on the quality, non-clinical, and clinical aspects of medicinal products containing genetically modiffed cells 含有转基因细胞的医药产品的质量、非临床和临床方面的指南 | 12/2020 | |
2 | Guideline on quality, non-clinical and clinical aspects of
medicinal products containing genetically modified cells 关于含有转基因细胞的药品质量、非临床、临床方面的指南 | 12/2020 | |
3 | Guidelines on good manufacturing practice for advanced therapy medicinal products 先进治疗医药产品良好生产规范指南 | 05/2018 | |
4 | Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products 基因治疗药物质量、非临床和临床方面指南 | 03/2018 | |
5 | Guideline on potency testing of cell based immunotherapy medicinal products for the treatment of cancer 细胞免疫治疗药物治疗癌症的效力测试指南 | 07/2016 | |
6 | Guideline on the risk-based approach according to annex I, part IV of Directive 2001/83/EC applied to advanced therapy medicinal products 根据指令 2001/83/EC 附件 I 第四部分适用于先进治疗医药产品的基于风险的方法指南 | 12/2013 | |
7 | Reflection paper on management of clinical risks deriving from insertional mutagenesis 关于插入诱变引起的临床风险管理的反思论文 | 04/2013 | |
8 | Reflection paper on design modifications of gene therapy medicinal products during development 关于基因治疗药物开发过程中设计修改的反思论文 | 12/2011 | |
9 | Guideline in follow-up of patients administered with gene therapy medicinal products 关于基因治疗药物患者随访的指南 | 10/2009 | |
10 | Guideline on scientific requirements for the environmental risk assessment of gene therapy medicinal products 基因治疗医药产品环境风险评估科学要求指南 | 05/2008 | |
11 | Guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products 先进治疗药物安全有效性随访及风险管理指南 | 11/2008 | |
12 | Guideline on the non-clinical studies required before first clinical use of gene therapy medicinal products 基因治疗药物首次临床使用前所需的非临床研究指南 | 05/2008 | |
13 | Guideline on human cell-based medicinal products 基于人类细胞的药物指南 | 05/2008 | |
14 | Guideline on non-clinical testing for inadvertent germline transmission of gene transfer vectors 关于意外基因检测的非临床试验指南 | 11/2006 | |
15 | Guideline on Development and Manufacture of Lentiviral Vectors 慢病毒载体开发和制造指南 | 05/2005 | |
