| 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 |
