Gildeeva GN and Belostotsky AV
The review outlines the current issues of Pharmacovigilance System in the Russian Federation, namely present state of regulatory aspects of PV system in Russia, regulatory requirements in Russia and in Eurasian Economic Union, review of the causes of under-reporting of ADRs. Specific focus has been made on topical issues such as a harmonization of the requirements to the Pharmacovigilance System, currently underway in Russia, the issue of Guidelines on Good Pharmacovigilance Practice (GVP) in the Eurasian Economic Union. These actions are aimed at improving and harmonizing the rules governing the main aspects of the Pharmacovigilance System in the Russian Federation. Also the review analyses one of the most important aspects in development of a new Pharmacovigilance System-the attitude towards pharmacovigilance in patients and healthcare professionals.
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Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report
