Perspectives and regulatory challenges for the application of stem cells in alternative methods to animal testing
DOI:
https://doi.org/10.22239/2317-269X.01076Keywords:
Stem Cells, Biotechnology, Health Legislation, Regulation, Alternative MethodsAbstract
Introduction: The use of stem cells for toxicological evaluations seems to be a promising strategy since it allows a greater prediction of human effects. However, in Brazil, there is no specific legislation regulating the use of stem cells for non-therapeutic purposes, technological development, diagnosis or as an alternative method to animal testing. Objective: To review the literature and to provide an overview of the current situation of the non-therapeutic use of stem cells in Brazil and in the world. Method: A non-systematic bibliographic survey was carried out bringing together scientific articles and legislation. Results: This review brings the current approach of Brazilian legislation regarding the non-therapeutic use of human material and briefly discusses international regulatory approaches that allow the non-therapeutic use of stem cells. On the other hand, the Brazilian legislation for use of blood and blood products is quite broad and mature and could serve as a model for the non-therapeutic use of stem cells or other materials of human origin. Conclusions: The encouragement of the debate by the interested bodies and entities is the first step to initiate the development of specific legislation that could allow the scientific and technological development of Brazil in order to follow the world’s biotechnological advances.Downloads
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