Cell and tissue therapy regulation: Worldwide status and harmonization

• Published in: Biologicals Vol. 40; no. 3; pp. 222 - 224
• Main Authors: Kellathur, Srinivasan N., Lou, Huei-Xin
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.05.2012
• Subjects: Australia; Biomedical Research - legislation & jurisprudence; Biomedical Research - methods; Biomedical Research - standards; Canada; Cell and tissue therapy; Cell- and Tissue-Based Therapy - methods; Cell- and Tissue-Based Therapy - standards; Drug Approval - legislation & jurisprudence; Drug Approval - methods; drugs; European Union; Government Regulation; Humans; Japan; Korea; Regulatory framework; Risk Assessment - legislation & jurisprudence; Risk Assessment - methods; Singapore; stem cells; therapeutics; tissue engineering; tissues; United States; Worldwide status; Canada; Singapore; United States; Europe; Japan; Korean Peninsula; Australia; Korea; Cell and tissue therapy; Regulatory framework; Worldwide status
• ISSN: 1045-1056; 1095-8320
• DOI: 10.1016/j.biologicals.2012.01.004

Rapid developments in scientific and technological aspects in stem cell biology and tissue engineering have led to the increased use of human cells and tissues for the treatment of various diseases and injuries. The regulatory environment for CTT products is rapidly evolving and drug regulatory agencies are working towards establishment of a risk-based system with some common features. Various drug regulatory agencies in many countries/regions have implemented regulatory controls in the last few years. This article will highlight some of works done till date to regulate CTT products in Australia, Canada, Europe, Japan, Korea, Singapore and United States of America.