The Law Is Approved. Administrative Code Amendments Required
The Federation Council approves Federal Law “On Biomedical Cell-Based Products”.
This law determines the basics of state regulation in the field of circulation, donation and research of biomedical cell-based products. It regulates issues related to development of cell-based products, their preclinical and clinical studies, expertise, marketing authorization and production. It also regulates processes related to quality control, marketing, use, storage, transport, import and export from RF, disposal of biomedical cell-based products intended for prevention, diagnostics and treatment of diseases or conditions in a patient, maintaining pregnancy and medical rehabilitation of patients. Besides that document regulates relationships related to donation of biological material with the purpose of production of biomedical cell-based products.
That document will help use a large amount of biological cell-based products that have been so far developed outside the legal environment. Now there will be an opportunity of their wide-scale clinical use.
The Federal Law will be effective as of January 1, 2017. But for some concepts another effective date. It is related to the fact that the new law will entail amendments to the Administrative Code, Criminal and Tax Codes and a number of regulations thereunder.