The Russian Ministry of Health has developed rules for working with biomedical cell products

The rules have been developed in accordance with the Federal Law of the Russian Federation №180-FZ dated 23.06.2016 “On Biomedical Cell Products”.

This initiative sets out general requirements for pre-clinical studies, production and quality control of biomedical cell products for medical use.

The rules establish a quality assurance system for the production of biomedical cell products and requirements for donor biological materials and cell lines used as starting material.