The Russian government has approved the rules for the circulation of personalized biotechnological drugs (BTLP)

BTLP is used for individual medical purposes and is produced on the basis of genetic research of human material directly in medical organizations.

The draft government resolution was submitted for public discussion by the Federal Medical and Biological Agency (FMBA) back in June 2024. However, the approved version of the document is significantly different. In particular, the terms and procedure for granting permits for the use of BTLPs have been revised. In addition, the requirements for medical organizations that can produce such drugs have also changed.

According to the new version of the document, BTLP will be allowed to be produced and used only by those medical organizations that receive special permission from the Ministry of Health (Ministry of Health). To do this, the clinic must submit a corresponding application and a number of documents, including a draft manufacturing regulation, a quality standard document, a patient information sheet, and instructions for use. If the expert opinion is positive, the Ministry of Health will enter the medical organization into the relevant electronic register. From the date of entry into this register, the permit is considered issued.

Clinics that have a license for medical activity, including permission to manufacture and use BTLP, will be able to synthesize BTLP. The list of other requirements includes the presence of intensive care and resuscitation departments, the implementation of scientific activities and activities to conduct clinical trials of drugs.

The drugs themselves, according to the document, must be produced in specially equipped premises located at the medical organization. At the same time, it is prohibited to produce different drugs in one area at the same time. The quality of the drugs must be checked in accordance with established standards, and all stages of production must be documented. The organization must keep a quality control journal for drugs.

BTLP may be used only in day hospital or inpatient settings "in accordance with the principle of priority of the patient's interests" and with the decision of the medical organization's medical commission. In addition, the clinic must provide Roszdravnadzor with information on each fact of BTLP use, as well as on cases of adverse reactions and a number of other reports.

The Ministry of Health's permit is valid indefinitely, but requires confirmation every 5 years. In case of violations, the permit for use may be revoked. The agency must make a decision on granting or refusing to issue a permit for the use of BTLP within 3 working days. The medical organization may send additional documents within 90 days after receiving the corresponding request from the Ministry of Health.

The regulator may assign the task of analyzing the application for permission to an expert institution. Each clinic must conclude an agreement on the provision of services for the assessment of individual BTLP with an expert institution. The analysis period must not exceed 50 working days.

It is worth noting that the three-day period for consideration of the application by the Ministry of Health does not take into account the time for collecting additional information from the applicant and the examination. As a result, the full process of consideration of the application may take up to 150 days.

* Source : GxP News.

The 27th International Exhibition of Equipment, Raw Materials and Technologies for Pharmaceutical Production Pharmtech & Ingredients will be held on November 25–28, 2025, in Crocus Expo IEC, Pavilion 2. We look forward to seeing you among the exhibitors of the leading business event in the pharmaceutical industry.

BOOK A STAND