Russia’s Ministry of Health has submitted for public consultation a draft legislative package introducing amendments to several federal laws governing the pharmaceutical sector. The proposals include new licensing provisions for drug manufacturing, revisions to clinical trial requirements, expanded grounds for importing medicinal products, changes to drug disposal regulations, and a significant extension of the time allowed for launching unannounced inspections of pharmaceutical facilities.

One of the key amendments concerns Federal Law No. 61-FZ “On the Circulation of Medicines.” The Ministry proposes introducing specific licensing provisions for the manufacture of medicinal products. Currently, the law contains special licensing procedures only for ethanol pharmaceutical substances and wholesale pharmaceutical distribution.

Under the proposed changes, if serious violations of licensing requirements result in severe harm or death of consumers, damage to animals, plants, or cultural heritage sites, the manufacturer’s certificate of compliance with Eurasian Economic Union (EAEU) Good Manufacturing Practice (GMP) standards may be suspended for up to 120 days. The suspension period could be extended by an additional 60 days at the manufacturer’s request.

The Ministry also seeks to establish a legal mechanism allowing authorities to suspend licenses at one or more production sites operated by a non-compliant manufacturer.

Facility inspections would continue to follow EAEU GMP rules, while decisions on restoring, terminating, or revoking licenses would be made according to procedures outlined in Federal Law No. 99-FZ “On Licensing Certain Types of Activities.”

Changes to Clinical Trial and Registration Requirements

The draft legislation would remove a provision currently allowing the submission of preclinical study results as part of the drug registration process.

At the same time, the Ministry proposes clarifying and expanding the documentation required to obtain approval for clinical trials. Existing requirements for product characteristics and pharmaceutical information would be supplemented with safety and efficacy data generated during preclinical studies. According to the proposal, such information should justify the use of the investigational product, including its dosage, route of administration, duration of treatment, and target patient population.

Expanded Import and Disposal Rules

The Ministry also proposes broadening the list of circumstances under which specific batches of registered and unregistered medicinal products may be imported into Russia. If adopted, the mechanism would allow the import of drug samples collected during GMP inspections.

In addition, the Ministry seeks to simplify drug destruction procedures by removing the requirement that organizations carrying out disposal activities hold a dedicated license for such operations.

Longer Window for Unannounced Inspections

A separate amendment would revise the Federal Law “On State and Municipal Control (Supervision) in the Russian Federation” by extending the period during which regulators may initiate unscheduled inspections of pharmaceutical facilities.

Current legislation requires supervisory authorities to begin such inspections within 24 hours. For pharmaceutical manufacturers, the Ministry proposes extending this period to 72 hours.

The public consultation on the draft legislation will remain open until June 9, 2026.

Aligning Russian Rules with EAEU Standards

According to the explanatory note accompanying the draft, the amendments are intended to improve the regulation of medicinal product circulation and strengthen compliance oversight.

The Ministry argues that existing legislation lacks mechanisms enabling inspectors to visit facilities anywhere along the pharmaceutical supply chain at any appropriate time, including without prior notification of the regulated entity or prior approval from prosecutors.

The proposal also reflects practical challenges faced by the Ministry of Industry and Trade, whose inspectors often require up to three days to reach manufacturing sites due to the absence of regional offices. Extending the response period to 72 hours would allow regulators to conduct unannounced inspections without notifying license holders while still informing prosecutorial authorities.

Several of the proposed amendments are intended to improve inspection procedures conducted by Roszdravnadzor for compliance with Good Clinical Practice (GCP), Good Distribution Practice (GDP), and Good Pharmacovigilance Practice (GVP) standards adopted by the Eurasian Economic Commission.

Another objective is to further harmonize Russia’s licensing and inspection framework with international regulatory approaches and EAEU legislation. The Ministry notes that regulators sometimes face difficulties revoking licenses through the courts when manufacturers fail to comply with GMP requirements, creating situations where mandatory EAEU quality standards are effectively ignored despite their importance for ensuring the safety, quality, and efficacy of pharmaceutical products.

The proposals follow recent regulatory reforms introduced in February 2026, when the Russian government approved amendments prepared by the Ministry of Health concerning Roszdravnadzor’s licensing procedures for medical equipment servicing. Those changes delegated certain administrative functions from the federal agency to its regional offices, with the stated goal of improving customer orientation and ensuring timely processing of licensing documents.

Source: Vademecum, May 12, 2026.