It is the first law concerning the use of biomedical technologies in Russia.
The Federal Law governs the development, pre-clinical and clinical studies, examination, state marketing authorization, quality assurance, manufacturing, marketing, storage, transportation, use, destruction, import and export of biomedical cell products to and from Russia for the purposes of prevention, disease diagnostics and treatment, maintenance of pregnancy and rehabilitation, and biomaterial donation. The law defines for the first time such important terms as ‘biomedical cell product’, ‘cell line’, ‘cell differentiation’, ’biological material donor’, ‘biomedical cell product safety’, and ‘biomedical cell product efficacy’.
The law envisages voluntary participation of patients in clinical trials involving biomedical cell products. Study participants are to be fully informed about a product, duration of a study, confidentiality aspects, anticipated risks and benefits and entitled to withdraw at any time. Pregnant and breastfeeding women may participate in clinical research experiments only if it is necessary for their treatment. Orphaned children, conscript soldiers, law enforcement officers and prisoners may participate in clinical trials of biomedical cell products.
To ensure the safe and effective use of such biomedical cell medications, the law provides their expert examination and the creation of the relevant state register. Marketing authorization will be a prerequisite for manufacturing, usage, transportation, import, export, and destruction of such medicinal products.
Thus, this law should become a legal base for bringing brand new medical products on the market. It is aimed to establish complex GMP- and GTP-oriented facilities to produce effective and safe cell products.
The law will enter into force on January 01, 2017. Follow this link to find out more.