Laws and Regulations
■ Proposed Approach to the Regulation of Cellular and Tissue-based Products
■ Human cells, tissue, and cellular and tissue-based products, or HCT/Ps (Title 21 CFR), Parts 1270 and 1271
■ PHS Act
■ Century Cures Act
Italy:
■ REGULATION (EC) No 1394/2007 on Advanced Therapy Medicinal Products (The ATMP Regulation)
European Union:
■ 2004/23/EC Directive
■ 1394/2007 Regulation
Japan:
■ Act on the Safety of Regenerative Medicine (再生医療等の安全性の確保等に関する法律)
■ Pharmaceuticals, Medical Device, and Other Therapeutic Product Act, PMD. Act (医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律)
China:
■ Stem Cell Clinical Trials Guidelines(干细胞临床研究管理办法〔试行〕)
■ (关于征求体细胞治疗临床研究和转化应用管理办法〔试行〕)
Taiwan:
■ Regulations Governing the Application of Specific Medical Examination Techniques and Medical Devices (特定醫療技術檢查檢驗醫療儀器施行或使用管理辦法)