The cells have grown to patients
Russians will have access to tissues and organs grown in laboratories
Maria Nedyuk, Izvestia
Tissues and organs grown in laboratories will be available to Russians next year. More than 30 such cellular products are already in a high degree of readiness, the director of the Department of Science, Innovative Development and Management of Biomedical Health Risks told Izvestia Ministry of Health of the Russian Federation Igor Korobko. Including laboratory–grown skin, cartilage tissues and products for the replacement of insulin-producing cells in type 1 diabetes.
The procedure for obtaining them should be determined by the Ministry of Health by the end of the year.
– Submission of documents for registration of such products should begin as early as January 1, 2018, – Igor Korobko explained. – The law is ready. It is very complicated because it is a completely new area of regulation. These are not medicines, not medical devices, but a separate type of products that will be used.
– Russian medicine has a powerful scientific base that allows it to be competitive at the international level. For example, an Ebola vaccine created in record time (based on biomedical technologies. – "Izvestia") and today it surpasses the world level, continuing to be the only registered vaccine in the world," Veronika Skvortsova said.
But in order for the law on biomedicine to work in full, changes must be made to a number of other federal regulatory documents that determine that the production of cellular products is a licensed type of activity. Now the Ministry of Health is working on this issue. According to Igor Korobko, which cellular products will be the first to reach the population depends on the willingness of manufacturers to invest.
– The law will require manufacturers to retrofit, adopt and implement the rules of good practice that ensures the quality of these products. There are more than 30 cellular products in a high degree of readiness," Korobko explained.
Among the almost ready–made ones are laboratory-grown skin, cartilage tissues and products for replacing insulin-producing cells in type 1 diabetes.
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