Cellular technologies in Russia
The beginning is made
Today, a huge number of tests of cellular products are carried out in the world. There is full regulation in the USA, Europe, and some Asian countries, and now the regulatory foundation has been laid in Russia. It is obvious that regenerative medicine will become in the future a highly effective tool in the fight against previously incurable diseases and a priority direction of development in the industry. This is confirmed by the news about the filing of the first application for licensing the production of a biomedical cell product (BMCP) for the restoration of cartilage tissue.
The field of cellular biomedicine is relatively new and promising, but it is not devoid of a number of nuances in the field of science and practice, which were discussed by experts at the VI annual conference organized by OST.
"If we look at the landscape of today's pharmaceutical market, the emergence of order in the field of biomedical cell products, the formation of an understanding of registration procedures and clinical research programs for such drugs is the most important and knowledge–intensive event that has occurred in recent years in the industry," said the director of the Center for Expertise and Control of Finished Medicines of the Federal State Budgetary Institution "NCESMP" of the Ministry of Health of Russia Dmitry Goryachev.
The participants of the discussion noted that the main problem at the moment is the lack of appropriate sites for the production of biomedical products. So, according to the experts of the BMKP Association, the cost of such a site is about 500 million rubles. In addition, Alexey Martynov, director of the Association of Biomedical Cell Products Manufacturers, outlined the relevance of training professional personnel, while noting that work on training and re-certification of specialists in the field of BMCP is already underway, relevant programs are being included in the country's universities.
"There are relevant orders of the Government of the Russian Federation, which approved the action plan for the development of biotechnologies for the period 2018-2020. The development program includes the creation of collective use centers, both in terms of the development of such drugs and their production, as well as the accreditation of medical institutions for the right to conduct such studies," said Deputy Director General of the Federal State Budgetary Institution "NCESMP" of the Ministry of Health of Russia Vadim Merkulov.
According to the Decree of the Government of the Russian Federation No. 337-r dated 28.02.2018, the number of medical organizations accredited to conduct clinical trials of biomedical cell products will increase from five in 2018 to 50 in 2020.
At the panel session "Cellular technologies in Russia: start of activities" were present: Alexey Alekhin (Ministry of Industry and Trade of the Russian Federation), Vadim Merkulov (FSBI "NCESMP" of the Ministry of Health of Russia), German Inozemtsev (Pharmaceutical Bulletin), Alexey Martynov (Association of Manufacturers of Biomedical Cell Products), Peter Timashev (I.M. Sechenov Institute of Regenerative Medicine), Yuri Sukhanov (NP "Association of Biomedical Experts, cellular Technologies and Regenerative Medicine"), Igor Pomytkin (I.M. Sechenov Institute of Regenerative Medicine), Alexey Lyundup (I.M. Sechenov Institute of Regenerative Medicine).
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