Russia Opens the Door for Stem Cell Clinical Trials

While the US, Europe and some Asian countries have had a fully functional, comprehensive regulatory platform for BCP procedures for over two decades, Russia is relatively new to the area, only recently approving a regulatory framework. 2018 marked a key breakthrough for the Russian market and the global pharmaceutical arena, when the Russian government enacted a law involving amendments to biomedical cell product guidelines, which officially opened the door for Russia to enter the stem cell technologies industry. The regulation stipulates and defines what a BCP is, specifying that both registered medical products and pharmaceuticals can be classified as BCPs.

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