Powers of Roszdravnadzor have been Exended
Roszdravnadzor will now be responsible for safety monitoring of biomedical cell-based products, as well as state control of drug circulation.
This news was announced at the web-portal of legal information, where the Statement of the Government of the Russian Federation of 31.01.2017 No 114 “On Making Amendments into the Statement on the Federal Service on Surveillance in the Field of Healthcare” was uploaded.
The document provisions, besides, the quality control, the monitoring of safety of biomedical cell-based products, public control of marketing and random quality control. The procedure of random control has been described in detail in the statement.
The relevant Roszdravnadzor agency receives the right to check compliance with the requirements for preclinical and clinical trials, manufacture, storage, and marketing, transport, use and destruction of biomedical cell-based products