This review provides an insight into the main historical milestones of development and narrates on current state of affairs of the system of pharmacological vigilance in Russia. Specific focus has been made on topical issues related to functioning of the system designed to monitor drugs safety nowadays: regular procedures in the field of pharmacovigilance in the Russian Federation, reporting and accountability of pharmaceutical products manufacturers and medical staff, the role played by regional centres for drugs safety monitoring, insufficient understanding of the part taken by patients/consumers in the system of pharmacovigilance, lack of adequate surveillance over safe use of drugs during pregnancy. Further to the foregoing, appropriate consideration has been given to the prospects of Russian pharmacovigilance and its harmonization with global practice.