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Pharmacovigilance in Russia in 2026: MAH Requirements

  • 15-11-2024
  • Posted by: Olga Krasnova
  • Category: Uncategorized
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Infographic showing the key processes of pharmacovigilance in Russia, focusing on drug safety, adverse event reporting, and compliance with Russian regulatory standards.

Pharmacovigilance in Russia in 2026: Requirements for MAHs

Updated 15 July 2026. Pharmacovigilance in Russia is governed by both national law and Eurasian Economic Union requirements. The key framework includes Article 64 of Federal Law No. 61-FZ, Roszdravnadzor Order No. 3518 of 17 June 2024 and the EAEU Good Pharmacovigilance Practice Rules approved by EEC Council Decision No. 87.

Authority and regulatory framework

  • Roszdravnadzor collects and evaluates safety reports, oversees compliance and takes regulatory safety measures.
  • Federal Law No. 61-FZ, Article 64 requires reporting of adverse reactions, lack of efficacy and other circumstances threatening life or health.
  • Roszdravnadzor Order No. 3518, registered on 5 September 2024, approved the current national pharmacovigilance procedure.
  • EEC Council Decision No. 87 establishes EAEU GVP requirements for the MAH pharmacovigilance system.
  • In 2024, common EAEU inspection rules were supplemented with pharmacovigilance-system inspection requirements.

Core MAH obligations

  • maintain an effective pharmacovigilance system and quality system;
  • ensure availability of the responsible pharmacovigilance person and current contact details;
  • maintain the pharmacovigilance system master file (PSMF);
  • collect, validate, follow up and submit ICSRs in the required format and timelines;
  • perform literature monitoring, signal management and continuous benefit–risk evaluation;
  • prepare PSUR/PBRERs and risk management plans where required;
  • maintain partner data-exchange arrangements, training, audits and inspection readiness.

Reportable safety information

The system should cover suspected adverse reactions, serious and unexpected cases, lack of therapeutic effect, medication errors, overdose, misuse, off-label use, occupational exposure, pregnancy and other circumstances that may change the benefit–risk profile. Applicable requirements determine the route and deadline for each report type.

Practical compliance checklist

  1. Reconcile SOPs and the PSMF with Order No. 3518 and current EAEU GVP.
  2. Verify access to Roszdravnadzor reporting channels and the back-up route.
  3. Ensure the four minimum criteria for a valid ICSR and active follow-up.
  4. Update safety-data exchange agreements with distributors and other partners.
  5. Document signal assessments, safety decisions and risk-minimisation actions.
  6. Perform database reconciliation, personnel training and internal audits.
  7. Maintain CAPA evidence and continuous inspection readiness.

Inspection readiness

Inspectors assess operational performance as well as documentation, including case-database completeness, decision traceability, consistency between the PSMF and real processes, partner agreements, training, vendor oversight and timely corrective actions.

Official sources

How PharmExpert can help

PharmExpert supports pharmacovigilance operations in Russia and the EAEU, including PSMF and SOP preparation, ICSR processes, audits and inspection readiness.

This article is for general information. Confirm the current national and EAEU requirements before taking regulatory action.