The Russian government has approved amendments developed by the Ministry of Health to the Regulation on Federal State Control (Oversight) in the Circulation of Medicinal Products. The document abolishes scheduled inspections for entities classified as significant, medium, or moderate risk, and sets the frequency of preventive visits based on risk category. The regulation also establishes new risk indicators for preclinical and clinical trials of medicines — values M1 and M2, which will be used to calculate scores for assigning a risk category.

Mandatory preventive visits will be carried out using the Inspector mobile application, through preventive consultations with company representatives, or via video conferencing. Notification must be provided no later than five business days before the visit, and if the visit is initiated by the regulated organization, its duration cannot exceed ten business days.

For high-risk entities, such visits will be conducted once a year. For all other categories, the frequency is determined by Government Resolution No. 1511 of October 1, 2025 “On the Frequency of Mandatory Preventive Visits Under State Control (Oversight) and Municipal Control.”

Specifically:

– For entities classified as significant risk or hazardous industrial facilities of hazard class III, no more than one preventive visit will occur every three years.
– For medium risk and hazard class IV facilities — no more than one every five years.
– For moderate risk — no more than one every six years.

The procedure for appealing decisions and actions (or inaction) of oversight authorities has also changed. Complaints must now be submitted electronically via the State Services portal and must be signed with an enhanced qualified electronic signature.

Two new risk indicators have been introduced for preclinical and clinical research.
Risk indicator M1 will be assessed based on four criteria related to the number of clinical trials conducted by a legal entity or individual entrepreneur:

– If 40 or more clinical trials were conducted in the past five years — 15 points.
– Fewer than 40 — 8 points.
– If 20 or more trials were conducted — 11 points.
– Fewer than 20 — 4 points.

Data will be taken from the registry of issued clinical trial permits.

Risk indicator M2 will be calculated using three criteria:

– If an organization conducts preclinical research without being listed in the OECD GLP-compliant laboratory register — 15 points.
– If the organization is included in the register — 3 points.
– Conducting preclinical research as an organizer — 4 points.

For preclinical and clinical research, the final risk category will be determined by adding M1 and M2:

– 15+ points — high risk
– 11–14 — significant risk
– 8–10 — medium risk
– 4–7 — moderate risk
– 3 or fewer — low risk

If a criterion is not applicable, it is assigned zero.

The updated regulation also changes scoring thresholds for assigning risk categories in wholesale drug distribution. Instead of six risk indicators, eight will now be used, with the addition of “preclinical research” (K7) and “clinical research” (K8), each worth one point.

Organizations with 50 points will be classified as high risk.
27–38 points correspond to medium risk.
Organizations with 15 points or fewer will be classified as low risk.

The Ministry of Health published the first draft of these amendments in late July 2025.

Source: Vademecum, November 17, 2025.