Clinical study of a biomedicinal cellular product
Clinical trial of a biomedical cellular product — the study of preventive, diagnostic, therapeutic, and rehabilitative properties of a biomedical cellular product during its use in humans with the aim of obtaining evidence of its safety and efficacy, data on adverse effects of such a product and undesirable reactions associated with its use, as well as information on the effect of interaction between the tested biomedical cellular product and other biomedical cellular products, medicinal drugs and (or) medical devices, food products1.
Federal Law No. 180-FZ dated June 23, 2016 "On Biomedical Cellular Products". 2016, as amended on January 1, 2017, Article 2, subpara. 28. ↩