Encyclopedia
Post-registration clinical study of a biomedical cellular product
Post-registration clinical study of a biomedical cellular product - a clinical study of a biomedical cellular product, the circulation of which in the Russian Federation is carried out after state registration, for the purpose of additional data collection on its safety and efficacy, expanding the indications for use of such a biomedical cellular product, as well as identifying adverse reactions to its use1.
Federal Law No. 180-FZ dated 23.06.2016 "On Biomedical Cellular Products". 2016, as amended on 01.01.2017, Article 2, subpara. 31. ↩