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Table 1: Current status of regulation of cell-based tissue engineering and regenerative medicine

From: Regulation challenge of tissue engineering and regenerative medicine in China

Country/region Current status
USA If it is intended to be used as medical technique in clinic, the following conditions must be fulfilled: Cells are (1) minimally manipulated, (2) homologously used, (3) not combined with a drug or device, and (4) have no systemic effect and do not depend upon the metabolic activity of living cells for the primary function (except for autologous use or allogeneic use in a first-degree or second-degree blood relative). Otherwise, it will be regulated as a medical product with premarket approval requirement
EU The following conditions need to be fulfilled: Cells (1) are not subjected to substantial manipulation, (2) have the same function, and (3) are not combined with medical devices, or if cells are prepared and used as a custom-made product for an individual patient in a hospital, their usage might be treated as medical technique. Otherwise, they should be presented as a medicinal product
Japan It is permitted to carry out human stem cell clinical research, even though stem cells are substantially manipulated or combined with non-cellular components
China There have not been any criteria related to the manipulation and usage of cells, which can be used to determine whether the medical technique mode or the medical product mode is desired