The Ministry of Health of the Russian Federation has developed a draft law changing the rules for personalized medicine. The draft amendments to the law “On the Circulation of Medicines,” which is published on the official portal, establish a special procedure for gene therapy products manufactured for a specific patient. The new norms will take effect on March 1, 2028.
Exemption from Registration for Patient Benefit
The main innovation is the exemption of individual gene therapy products from the mandatory state registration requirement. This harmonizes Russian law with EAEU standards, which already allow the use of unregistered medicines if they are produced strictly for a specific individual. The term “tissue-engineered medical products” is also introduced.
Full-Cycle Control
Despite the exemption from registration, the circulation of such drugs will be strictly regulated. The draft law covers the entire cycle: from development and preclinical studies to quality control, storage, and mandatory destruction. Only clinics that have received a special permit from the Government of the Russian Federation will be able to manufacture these products.
Scientific and Ethical Expertise
A multi-level verification system is provided for patient safety:
- Scientific Assessment: A specialized federal institution will issue permits for the manufacture of products synthesized based on the results of the patient’s genetic material research.
- Ethical Expertise: An ethics council will issue opinions on the justification for using such individual drugs.
Post-registration monitoring of efficacy and safety is assigned to Roszdravnadzor.
Focus on Technological Sovereignty
The initiative continues the development of genetic technologies in Russia through 2030. The goal is to develop original high-tech products for treating socially significant diseases and to strengthen the country’s drug security.
