Russia Launches Stem Cell Clinical Trials & Seeks to Catch up with West & Asia

Mar 28, 2019 | Regulations, Russia, Stem Cell Clinical Trials


Chelsea Weidman Burke, M.S. of Biospace, reports Russia has launched its biomedical cell products initiative.  Ms. Weidman Burke states “It is lagging behind the U.S., Europe and some Asian nations which have developed functional, holistic regulatory platforms for biomedical cell product procedures for over two decades.” In 2018, Russia established new law involving amendments to biomedical cell product guidelines—included here. They seek to catch up. Ms. Weidman Burke quotes Dmitry Goryachev, head of Expertise and Control of Ready Medicaments at the FSBI Russian Ministry of Health Scientific Centre for Expert Evaluation of Medicinal Products: “When speaking about the current pharma industry landscape, the major development of the past several years is, without a doubt, the creation and implementation of stem cell product regulation and related clinical trial procedures.”