ISSCR Guidelines for Stem Cell Research and ClinicalTranslation.2021.
 FDA. Guidance for FDA Reviewers and Sponsors. Content and Review?of Chemistry, Manufacturing, and Control (CMC) Information for Human?Somatic Cell Therapy Investigational New Drug Applications (INDs). 2008.
 FDA. Chemistry, Manufacturing, and Control (CMC) Information for?Human Gene Therapy Investigational New Drug Applications (INDs). 2020.
 FDA. Deviation Reporting for Human Cells,Tissues,and Cellular and?Tissue-based Products Regulated Solely Under Section 361 of the Public Health?Service Act and 21CFR Part 1271. 2017.
 FDA《Guidance for Industry；Potency Tests for Cellular and Gene?Therapy Products》. 2011.
 EMA. Reflection paper on stem cell-based medicinal products. 2011.
 PMDA. ヒト ES 細胞加工醫薬品等の品質及び安全性の確保について. 2012.
 ICH Guidance on Quality of Biotechnological/Biological Products:Derivation and Characterization of Cell Substrates Used for Production of?Biotechnological/Biological Products, (63 FR 50244, September 21, 1998).
 ICH. Q5E Comparability of Biotechnological/Biological Products?Subject to Changes in Their Manufacturing Process.2004.
 ICH. Q5C Stability Testing of Biotechnological and Biological?Products.1995.