BMCBP Manufacture: Licensing is Compulsory
On January 1, 2017 Federal Law “On Biomedical Cell-Based Products” became effective. It defines BMCBPs as a high-tech product, manufactured based on cell lines, intended for prevention, diagnostics and treatment of diseases or conditions of patient, maintenance of pregnancy and medical rehabilitation of a patient. But it is not a medicinal drug or a medical device.
The law regulates processes related to BMCBP circulation: preclinical and clinical studies, expertise, state authorization, manufacture, quality control, sales, use, storage, transporting, import to the RF, export from the RF, disposal of the drugs. It also regulates relations in connection with donation of biological material required for manufacture of BMCBPs.
BMCBP manufacturing activities are subject to compulsory licensing. The corresponding regulation was prepared by the Ministry of Healthcare of the Russian Federation. The draft of the statute is under public discussion, which will continue to February 1, 2017.
The text is available at the official website regulation.gov.ru at the following link: http://regulation.gov.ru/p/60843.