title: Cell and tissue therapy regulation: worldwide status and harmonization.
abstract: 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.
authors.affiliation: Pharmaceuticals and Biologics Branch, Pre-Marketing Division, Health Products Regulation Group, Health Sciences Authority, Singapore, Singapore. kellathur_srinivasan@hsa.gov.sg
authors.forename: Srinivasan N
authors.initials: SN
authors.lastname: Kellathur
authors.forename: Huei-Xin
authors.initials: HX
authors.lastname: Lou
mesh_terms: D001315:Australia; D035843:Biomedical Research / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards*; D002170:Canada; D064987:Cell- and Tissue-Based Therapy / Q000379:methods / Q000592:standards*; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods; D005062:European Union; D033161:Government Regulation; D006801:Humans; D007564:Japan; D007723:Korea; D018570:Risk Assessment / Q000331:legislation & jurisprudence / Q000379:methods; D012846:Singapore; D014481:United States