For the safety of cellular technologies
Ministry of Health and Social Development of Russia: Cellular products are put on the market without carrying out examinations of their safety and effectiveness
This was reported by the deputy . Minister of Health and Social Development of the Russian Federation Veronika Skvortsova at a meeting on the regulation of the circulation of cells, tissues and products based on them in the Russian Federation. The meeting was attended by leading experts in this field – academicians of the Russian Academy of Medical Sciences, experts from leading specialized institutions.
"The current mechanism of entry of cellular products into the market is not based on the examination of their safety and effectiveness. The existing legal procedures do not involve a detailed analysis of the cell products administered to patients for the stability of the cell line, the absence of infection of the cell line with microorganisms and contamination, the results of testing the cell line for the ability to turn into tumor cells or cause tumor formation and the ability to cause disturbances in the development of the human embryo and fetus. This is categorically unacceptable!", – Veronika Skvortsova noted.
As stated in the message of the Ministry of Health and Social Development of Russia, the participants of the meeting agreed on the need to adopt legislative acts that would define the requirements for both subjects of activity and infrastructure in the field of cellular technologies, and the procedure for registration of cellular products. The discussion will continue in the format of a working group of the Ministry of Health and Social Development of Russia, which will include representatives of the general scientific community.
Veronika Skvortsova assured the participants of the meeting that in this matter the Ministry attentively listens to the opinion of the professional community.
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01.03.2012