Regulation&Guideline（Intl org）

Regulation&Guideline（Intl org）
No	Regulation&Guideline	Issued by	Release time	Download
01	Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin	ICH	1999/9/23	pdf
02	Q5D: Derivation and Characterisation of Cell Substrates Used for Production of BiotechnologicalBiological Products	ICH	1997/7/16	pdf
03	An inventory of shedding data from clinical gene therapy trials	ICH	2007/7/30	pdf
04	General Principles to Address Virus and Vector Shedding	ICH	2009/6/1	pdf
05	Final Concept Paper M6: Guideline on Virus and Gene Therapy Vector Shedding and Transmission	ICH	2009/8/26	pdf
06	Final Concept Paper M6: Guideline on Virus and Gene Therapy Vector Shedding and Transmission	ICH	2009/8/27	pdf
07	Guide on advanced therapy medicinal products - Quality flowchart	EMA	2021/11/29	pdf
08	Guide on advanced therapy medicinal products - Quality checklist	EMA	2021/11/29	pdf
09	Guide on advanced therapy medicinal products - Non-clinical development checklist	EMA	2021/11/29	pdf
10	Guide on advanced therapy medicinal products - Non-clinical development flowchart	EMA	2021/11/29	pdf
11	Guide on advanced therapy medicinal products - Clinical development flowchart	EMA	2021/11/29	pdf
12	Guide on advanced therapy medicinal products - Clinical development checklist	EMA	2021/11/29	pdf
13	ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update	EMA	2021/5/27	pdf