Draft law on cellular technologies in medicine

Draft Federal Law "On the Circulation of Biomedical Cell Products"

ConsultantPlusThe Ministry of Health of the Russian Federation has submitted a draft federal law regulating the process of circulation of biomedical cell products, that is, their development, preclinical and clinical studies, examination, state registration, production, storage, disposal, use and monitoring of use, as well as their import and export

Biomedical cell product is a product consisting of a cell (cell) line and auxiliary substances or consisting of a cell (cell) line and auxiliary substances in combination with pharmaceutical substances and (or) medical products. For the preparation of cell lines intended for the production of biomedical cell products, human cells are used, including human fetal membrane cells isolated from the placenta, umbilical cord jelly and umbilical cord blood of a person after normal childbirth, as well as cells of a deceased person.

According to the draft federal law, its effect does not apply to relations arising during the development and production of medicines and medical devices, donation and transplantation (transplantation) of organs (their parts), human tissues and cells, donation of blood and its components; relations arising during the collection and use of whole cord blood of a person, as well as relations arising from the circulation of human cells and tissues for scientific and educational purposes.

The draft stipulates that biomedical cell products previously registered as part of medical technologies are subject to confirmation of state registration of a biomedical cell product in accordance with the requirements of this federal law by January 1, 2015 without levying a state fee. Until a decision is made to confirm state registration, these biomedical cell products may be in circulation in accordance with the legislation of the Russian Federation.

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