The Ministry of Health will update the rules for monitoring biomedical cell products

The key proposed change is the transition to an expanded risk model: instead of three categories, five are introduced - from high to low risk. Scheduled inspections are retained only for high-risk facilities and are conducted every two years; for significant, medium, moderate and low risks, scheduled events are not provided. Mandatory preventive visits may become annual for the high-risk group, for other categories their frequency will be established by the government, for low risk, visits are not planned. A preventive visit at the initiative of the monitored person is limited to three working days.

Some of the project's activities are being transferred to a digital format: inspection visits, checks and examinations will be carried out remotely, including using the Inspector mobile application and video communication. Photo and video recording will be carried out using official equipment, and the materials will be attached to the acts. This initiative continues the pilot project "Mobile Inspector", the implementation of which began in 2024 on the instructions of the head of the government apparatus Dmitry Grigorenko.

It is proposed to reduce the timeframe for reviewing complaints from 20 working days under the current version to 15. Complaints about assigning a risk category should be reviewed for no more than five working days. It is planned to expand the list of Roszdravnadzor officials authorized to issue warnings.

In early August 2023, Russian President Vladimir Putin signed a law approving the procedure for circulation of BMCP. From April 1, 2024, state registration of BMCPs specially produced for a specific patient directly in a medical organization became unnecessary. For example, this affected the so-called "academic" CAR-T drugs.

According to the new law, high-tech drugs subject to registration under the rules of the EAEU, as well as transplantation objects, are exempted from the Federal Law No. 180-FZ of June 23, 2016 "On Biomedical Cell Products". In particular, mandatory registration will not be required for importing BMCP into Russia.