As stem cell research moves toward offering more clinical applications, questions arise about how relevant products will be regulated. To date these questions have received relatively little attention compared to the legal and ethical issues associated with stem cell research, (1) but they will become increasingly important as technology advances. In consultations on the pressing ethical issues relevant to stem cell translational research, one of the concerns identified was the "adequacy of our current system of oversight for both innovative therapies and clinical trials for addressing the unique challenges presented by stem cell research." (2) This article will outline and discuss the regulatory regimes that would apply to stem cell-based products as therapeutic products. Part one provides an introduction to stem cells and their potential therapeutic uses, including the different types of stem cell-based products and the safety, efficacy and quality issues associated with these products. Part two then describes the regulatory regimes that would apply to stem cell-based products in Canada, the United States, Europe and Australia. Finally, the third part discusses the key issues and challenges that arise in the regulation of these products.