Building 4, Yuewang Wisdom Valley, 1463 Wuzhong Avenue, Wuzhong District, Suzhou, China
400-900-1882
bd@hillgene.com
Regulation&Guideline（Intl org）
2023-01-20
谱新生物Hillgene
Regulation&Guideline（Intl org）
No
Regulation&GuidelineIssued byRelease timeDownload
01Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal OriginICH1999/9/23pdf
02Q5D: Derivation and Characterisation of Cell Substrates Used for Production of BiotechnologicalBiological ProductsICH1997/7/16pdf
03An inventory of shedding data from clinical gene therapy trialsICH2007/7/30pdf
04General Principles to Address Virus and Vector SheddingICH2009/6/1pdf
05Final Concept Paper M6: Guideline on Virus and Gene Therapy Vector Shedding and TransmissionICH2009/8/26pdf
06Final Concept Paper M6: Guideline on Virus and Gene Therapy Vector Shedding and TransmissionICH2009/8/27pdf
07Guide on advanced therapy medicinal products - Quality flowchartEMA2021/11/29pdf
08Guide on advanced therapy medicinal products - Quality checklistEMA2021/11/29pdf
09Guide on advanced therapy medicinal products - Non-clinical development checklistEMA2021/11/29pdf
10Guide on advanced therapy medicinal products - Non-clinical development flowchartEMA2021/11/29pdf
11Guide on advanced therapy medicinal products - Clinical development flowchartEMA2021/11/29pdf
12Guide on advanced therapy medicinal products - Clinical development checklistEMA2021/11/29pdf
13ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 updateEMA2021/5/27pdf


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