Pharmacovigilance in Russia: current state of affairs, challenges, and prospects

Abstract

This review outlines current issues of the pharmacovigilance (PV) system in the Russian Federation, namely the present state of regulatory aspects, regulatory requirements in both Russia and the Eurasian Economic Union, and review of causes of under-reporting of adverse drug reactions. Specific attention will be focused on how the system is designed to monitor drug safety functions, reporting and accountability of pharmaceutical products, their manufacturers and medical staff, the role played by regional centers for drug-safety monitoring, and insufficient understanding of the part taken by patients in the system of PV. The prospects of the Russian PV system and its harmonization with global practice will also be discussed.

Keywords:

• Pharmacovigilance
• adverse reactions
• drugs’ safety monitoring
• Eurasian Economic Union
• Federal Service for Surveillance in Healthcare

Transparency

Declaration of funding

No funding was received.

Declaration of financial/other relationships

G.G. and A.B. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgment

The authors are thankful to prof. Yurkov V.I. for scientific assistance with the manuscript.