Recent changes in the pharmacovigilance system in the Russian Federation and the EAEU
The Eurasian Economic Union (EAEU) is an international organization for regional economic integration, established by the Treaty on the Eurasian Economic Union, which currently includes 5 countries – Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan. The EAEU ensures the freedom of goods movement, as well as services, capital and labor, conducting a coordinated, agreed/unified economic policy. The current practice of pharmacovigilance in the EAEU is of interest to potential foreign investors and market players.
The united EAEU drug market is a complex system that incorporates 35 regulations, including the variety of good practice guidelines regarding the circulation of medicinal products (GMP, GCP, GLP, GDP, and GVP). This group of regulations contains basic documents on the inspection of production lines, the assessment of generic equivalence, the development of biological drugs, and the pharmacovigilance (PV). The common EAEU database of identified ADRs has been already initiated, but the number of incoming signals is quite small. The most common flaws of the PSUR are the late reports, the incorrect format and contents of those; the discrepancy between the Patients information leaflet and the Summary of Product Characteristics, and the lack of important and relevant scientific and clinical information. In the EAEU, the submission of Risk Management Plan as part of the registration dossier is required for any new medication, including a new combination of drugs. Gildeeva G.N., Belostotsky A.V. Recent changes in the pharmacovigilance system in the Russian Federation and the EAEU. FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology. 2019;12(2):86-90. (In Russ.)