Manufacturers now must follow new registration requirements once stem-cell products are approved for market, under rules the Russian authorities just adopted.
The new rules follow last month’s regulation that required stem-cell clinical trials to be conducted in accordance with good clinical practices (GCPs). The requirements are part of a government initiative to facilitate development of new stem-cell technologies.
On Sept. 15, the Russian Health Ministry officially published Order No. 567n to approve registration procedures and forms for stem-cell treatments before they can enter the market. According the rules approved by the order, stem-cell product registration will be conducted by the ...
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