Russia has approved regulations governing the circulation of personalized biotechnological drugs, known as individualized biotechnology derived medications, according to a government resolution published on the legal acts portal. These drugs, tailored for individual medical purposes, are produced based on genetic material research conducted directly within healthcare organizations.
The Federal Medical and Biological Agency (FMBA) initially proposed the draft for public discussion in June 2024, but the approved version of the document has undergone significant revisions. Notably, the timelines and procedures for obtaining permits to use biotech drugs have been overhauled, along with adjustments to the requirements for medical organizations engaged in the production of these drugs. Under the new regulations, only medical organizations that obtain special permits from the Ministry of Health will be allowed to manufacture and administer biotech drugs. To secure such a permit, a clinic must submit an application along with various documents, including a manufacturing regulation project, a quality standard document, a patient information sheet, and usage instructions. Following a positive review, the Ministry will add the medical organization to an electronic registry, with the permit becoming effective from the date of inclusion.
Clinics intending to synthesize biotech drugs must hold a medical activity license and a specific permit for the production and application of these drugs. Additional criteria include having intensive care and resuscitation departments, as well as conducting research activities and clinical drug trials.
The production of biotech drugs must occur in specially equipped facilities within the healthcare organization, and simultaneous production of different drugs in the same area is prohibited. Drug quality will be monitored according to established standards, and all manufacturing stages must be documented in a quality control
register.
The use of biotech drugs is restricted to day hospitals or in-patient settings, based on the principle of prioritizing patient interests and subject to the approval of the hospital’s medical commission. Healthcare organizations are also mandated to report each instance of personalized biotech drug usage to the Federal Service for
Surveillance in Healthcare (Roszdravnadzor), including any adverse reactions and other related reports.
Permits issued by the Ministry of Health are indefinite but require confirmation every five years. Violations may lead to the revocation of the permit. The Ministry is obligated to decide whether to grant or deny permission for the use of a personalized biotech drug within three working days. Additionally, medical organizations may submit extra documents within 90 days of receiving a request from the Ministry of Health.
The regulator can refer the assignment for analysis to an expert institution, with each clinic required to contract such an institution for evaluating the individualized biotech drugs. The analysis period must not exceed 50 working days.
However, the Ministry’s three-day review period does not include the time taken to gather additional data from the applicant or for the expert assessment, potentially extending the complete processing time for requests to up to 150 days.
