The Prime Minister of Russian Federation, Dmitry Medvedev, signed a decree approving a regulation on licensing activities for the production of biomedical cell products (BMCP). The document was published on the official Internet portal of legal information on October 5, 2018.
The production of BMCP means the production of autologous, allogeneic, combined products for preclinical and clinical studies, including those unregistered in Russia.
The license can be issued only to those organizations that, among other things, have a site that complies with the regulations and rules of the Good Manufacturing Practice for BMCP. The licensee must have a contract for the supply of biomaterial for the production of BMCP by health institutions, the staff, including the “Authorized person” that has been certified.
Roszdravnadzor will issue the license. At the end of August 2018, the Ministry of Health proposed to allow the importation of some unregistered BMCP for research purpose, but only temporarily – until April 30, 2019.
FZ-180 “On Biomedical Cellular Products” dated June 23, 2016 defines BMCP as a “combination consisting of a cell line (or lines) and auxiliary substances”, including “state-registered” drugs and medical devices. However, according to the industry participants, at least 15 more legal acts with different status are needed to legitimize the segment and form a full-fledged market of BMCP.