序号
| 名称 | 发布单位 | 发布时间 | 下载文件 |
| 01 | 干细胞研究和临床转化指南 | 国际干细胞研究（ISSCR） | 2021/5/27 | pdf |
| 02 | Guide on advanced therapy medicinal products - Quality flowchart | 欧洲药品管理局EMA | 2021/11/29 | pdf |
| 03 | Guide on advanced therapy medicinal products - Quality checklist | 欧洲药品管理局EMA | 2021/11/29 | pdf |
| 04 | Guide on advanced therapy medicinal products - Non-clinical development checklist | 欧洲药品管理局EMA | 2021/11/29 | pdf |
| 05 | Guide on advanced therapy medicinal products - Non-clinical development flowchart | 欧洲药品管理局EMA | 2021/11/29 | pdf |
| 06 | Guide on advanced therapy medicinal products - Clinical development flowchart | 欧洲药品管理局EMA | 2021/11/29 | pdf |
| 07 | Guide on advanced therapy medicinal products - Clinical development checklist | 欧洲药品管理局EMA | 2021/11/29 | pdf |
| 08 | Final Concept Paper M6: Guideline on Virus and Gene Therapy Vector Shedding and Transmission | ICH | 2009/8/27 | pdf |
| 09 | Final Concept Paper M6: Guideline on Virus and Gene Therapy Vector Shedding and Transmission | ICH | 2009/8/26 | pdf |
| 10 | General Principles to Address Virus and Vector Shedding | ICH | 2009/6/1 | pdf |
| 11 | An inventory of shedding data from clinical gene therapy trials | ICH | 2007/7/30 | pdf |
| 12 | Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin | ICH | 1999/9/23 | pdf |
| 13 | Q5D: Derivation and Characterisation of Cell Substrates Used for Production of BiotechnologicalBiological Products | ICH | 1997/7/16 | pdf |
