REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot104810.21518/1561-5936-2019-3-8-14Original ArticleRussian pharmacovigilance in a newly regulated environment: two-year results and prospectsGlagolevS. V.noemail@neicon.ruGorelovK. V.noemail@neicon.ruChizhovaD. A.noemail@neicon.ruState Regulation of Medical Product Quality of RoszdravnadzorFederal Service for Healthcare Supervision03122019381418032022Copyright © 2019,2019The article presents a review of recent changes in the pharmacovigilance legislation, an analysis of drug safety monitoring activities of the Federal Service for Healthcare Supervision, a review of the current activities on improving pharmacovigilance, and outlines its development prospects.pharmacovigilancerequirementsdocumentsRoszdravnadzorфармаконадзортребованиядокументыРосздравнадзор1.Gautam A., Pan X. The changing model of big pharma: impact of key trends. Drug Discov Today. 2016 Mar;21 (3):379-84.2.Brinegar K., Yetisen A.K., Choi S., Vallillo E., Ruiz-Esparza G.U., Prabhakar A.M., Khademhosseini A., Yun S.H. The commercialization of genome-editing technologies. Crit Rev Biotechnol. 2017 Nov;37 (7):924-932.3.Coppens D.G. M., de Wilde S., Guchelaar H.J., De Bruin M.L., Leufkens H.G. M., Meij P., Hoekman J. A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making. Cytotherapy. 2018 Jun;20 (6):769-778.4.Kondo H., Hata T., Ito K., Koike H., Kono N. The Current Status of Sakigake Designation in Japan, PRIME in the European Union, and Breakthrough Therapy Designation in the United States. Ther Innov Regul Sci. 2017 Jan;51 (1):51-54.5.Mostaghim S.R., Gagne J.J., Kesselheim A.S. Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study. BMJ. 2017 Sep 7;358: j3837.6.Bahri P., Tsintis P. Pharmacovigilance-related topics at the level of the International Conference on Harmonisation (ICH). Pharmacoepidemiol Drug Saf. 2005 Jun;14 (6):377-87.7.Jeetu G., Anusha G. Pharmacovigilance: a worldwide master key for drug safety monitoring. J Young Pharm. 2010 Jul;2 (3):315-20. препаратов, в то время как использование IT-технологий позволит оптимизировать затраты на разработку новых лекарственных средств и управление рисками в пострегистрационном периоде.8.Lamarque V., Merle L., Demarez J.P.; Round Table No. 7, Giens XXIII. Generics and substitution modalities: proposed methods for the evaluation of equivalence,traceability and pharmacovigilance reporting. Therapie. 2008 Jul-Aug;63 (4):301-9.9.Lu Z. Information technology in pharmacovigilance: Benefits, challenges, and future directions from industry perspectives. Drug Healthc Patient Saf. 2009;1:35-45.10.Lengsavath M., Dal Pra A., de Ferran A.M., Brosch S., Harmark L., Newbould V., Goncalves S. Social Media Monitoring and Adverse Drug Reaction Reporting in Pharmacovigilance: An Overview of the Regulatory Landscape. Ther Innov Regul Sci. 2017 Jan;51 (1):125-131.11.Dobkin B.H. Wearable motion sensors to continuously measure real-world physical activities. Curr Opin Neurol. 2013 Dec;26 (6):602-8.12.Izmailova E.S., Wagner J.A., Perakslis E.D. Wearable Devices in Clinical Trials:Hype and Hypothesis. Clin Pharmacol Ther. 2018 Jul;104 (1):42-5213.Мурашко М.А., Косенко В.В., Асецкая И.Л., Поливанов В.А., Глаголев С. В. Новые требования к мониторингу безопасности лекарственных средств в Российской Федерации. Вестник Росздравнадзора. 2017;2:17-21.14.https://www.ncbi.nlm.nih.gov/ pubmed/28816174.15.https://www.ema.europa.eu/en/ documents/annual-report/2017-annual-report-european-medicines-agency_ en.pdf.