Pharmacovigilance system in Eurasian Economic Union
https://doi.org/10.24411/2588-0519-2018-10059
Abstract
The article deals with the main provisions of the basic document — «Rules of good practice of pharmacovigilance of the Eurasian economic Union», which regulates the study and prevention of adverse reactions and other problems associated with drugs in the member States of the Union, including the Russian Federation. Also, the Rules establish requirements for the organization of pharmacovigilance system in pharmaceutical companies, detail the work of manufacturers in the field of risk management, as well as determine the procedure for informing employees of the pharmaceutical industry and specialists of medical institutions of the authorized bodies about the identified safety problems in the use of medicines.
About the Authors
I. L. Asetskaya
«Pharmacovigilance Center» of Federal State Budget Institution «Informational-Methodological Center for the Expertise, Accounting and Analysis of Medical Products Circulation» of Roszdravnadzor; Peoples’ Friendship University of Russia
Russian Federation
Russian Federation
Asetskaya Irina - MD, PhD, assistant of professor of the Department of General and Clinical Pharmacology, Peoples’ Friendship University of Russia; Federal State Budget Institution «Informational-Methodological Center for the Expertise, Accounting and Analysis of Medical Products Circulation» of Roszdravnadzor; Chief specialist of «Pharmacovigilance Center» of Federal State Budget Institution «Informational-Methodological Center for the Expertise, Accounting and Analysis of Medical Products Circulation» of Roszdravnadzor.
Moscow.
S. K. Zyryanov
Peoples’ Friendship University of Russia
Russian Federation
Russian Federation
Zyryanov Sergey - MD, professor, Head of Department of General and Clinical Pharmacology, Peoples’ Friendship University of Russia.
Moscow.
SPIN-code: 6912-3783
A. S. Kolbin
First St. Petersburg State Medical University named after I.P. Pavlova
Russian Federation
Russian Federation
Kolbin Alexey - MD, Professor, Head of the Department of Clinical Pharmacology and Evidence-Based Medicine, First St. Petersburg State Medical University named after I.P. Pavlova; professor of the Department of Pharmacology, Medical Faculty, St. Petersburg State University.
SPIN-code: 7966-0845
D. Yu. Belousov
LLC «Center for Pharmacoeconomics Research»
Russian Federation
Russian Federation
Belousov Dmitry - General Director of LLC «Center for Pharmacoeconomics Research».
Moscow; tel. + 7 (910) 449-22-73.
SPIN-code: 6067-9067
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Review
For citations:
Asetskaya I.L., Zyryanov S.K., Kolbin A.S., Belousov D.Yu. Pharmacovigilance system in Eurasian Economic Union. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2018;(4):53-72. (In Russ.) https://doi.org/10.24411/2588-0519-2018-10059
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