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国际细胞治疗行业相关法律法规指南

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  • 干细胞研究和临床转化指南
    国际干细胞研究（ISSCR）
    2021-05-27
  • Guide on advanced therapy medicinal products - Quality flowchart
    欧洲药品管理局EMA
    2021-11-29
  • Guide on advanced therapy medicinal products - Quality checklist
    欧洲药品管理局EMA
    2021-11-29
  • Guide on advanced therapy medicinal products - Non-clinical development checklist
    欧洲药品管理局EMA
    2021-11-29
  • Guide on advanced therapy medicinal products - Non-clinical development flowchart
    欧洲药品管理局EMA
    2021-11-29
  • Guide on advanced therapy medicinal products - Clinical development flowchart
    欧洲药品管理局EMA
    2021-11-29
  • Guide on advanced therapy medicinal products - Clinical development checklist
    欧洲药品管理局EMA
    2021-11-29
  • Final Concept Paper M6: Guideline on Virus and Gene Therapy Vector Shedding and Transmission
    ICH
    2009-08-27
  • Final Concept Paper M6: Guideline on Virus and Gene Therapy Vector Shedding and Transmission
    ICH
    2009-08-26
  • General Principles to Address Virus and Vector Shedding
    ICH
    2009-06-01
  • An inventory of shedding data from clinical gene therapy trials
    ICH
    2007-07-30
  • Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
    ICH
    1999-09-23
  • Q5D: Derivation and Characterisation of Cell Substrates Used for Production of BiotechnologicalBiological Products
    ICH
    1997-07-16