A Wider Circle!
Issues of regulating the circulation of biomedical cell-based products (BCP) were discussed at the meeting of the Duma Subcommittee on production and circulation of medicinal devices and import substitution. Members of the subcommittee remarked the interest of investors in connection with law of biomedical cell-based products and approval of good practice rules.
However, according to the participants of the meeting, it is important that the system of marketing authorization goes hand in hand with the system of surveillance both in production of methods, and in enforcement of regulations. And, which is very important, in interpretation of results of studies. Therefore, according to general director of ARPM Victor Dmitriev, the circle of experts involved in discussion of issues of BCP circulation, must be extended by means of representatives of Roszdravnadzor, as well as scientists and practicing clinicians working in that area. Participants of the discussion supported the offer.