Signal Management: Updated Requirements of the EAEU Good Pharmacovigilance Practice
https://doi.org/10.30895/2312-7821-2023-11-1-38-45
Abstract
The Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union (EAEU GVP Guideline) came into force in the EAEU Member States in 2017. Over the next 5 years, marketing authorisation holders and competent authorities managed to build effective pharmacovigilance systems. The current version of the EAEU GVP Guideline was published in May 2022 and enacted on 6 December 2022. Amongst the critical pharmacovigilance processes, a special place is reserved to the process of signal management.
The aim of the study was to analyse the new content of the EAEU GVP Guideline related to signal management.
The authors reviewed the amendments introduced to the module of the EAEU GVP Guideline on signal management. This article is the first scholarly publication in the Russian language on the updated signal management process. The key changes include a detailed consideration of terminology issues, signal validation and prioritisation processes, notifying competent authorities of signal evaluation results, managing emerging safety issues, and functions of new automated systems: an integrated database of adverse drug reactions and a system for tracking safety issues.
Keywords
safety signal,
emerging safety issues,
pharmacovigilance,
Good Pharmacovigilance Practice,
drug safety
Funding: The study was performed without external funding.
About the Authors
A. V. Matveev
National Pharmacovigilance Research Center; Russian Medical Academy of Continuous Professional Education
Russian Federation
Russian Federation
Alexander V. Matveev, Cand. Sci. (Med.), Associate Professor
105005, Moscow, Baumanskaya St., 6/2
125993, Moscow, Barrikadnaya St., 2/1/1
A. E. Krasheninnikov
National Pharmacovigilance Research Center; N.I. Pirogov Russian National Research Medical University
Russian Federation
Russian Federation
Anatoly E. Krasheninnikov, Dr. Sci. (Pharm.), Associate Professor
105005, Moscow, Baumanskaya St., 6/2
117997, Moscow, Ostrovityanov St., 1
A. Yu. Zelinskaya
National Pharmacovigilance Research Center
Russian Federation
Russian Federation
Alexandra Yu. Zelinskaya
105005, Moscow, Baumanskaya St., 6/2
References
1. Matveev AV, Krasheninnikov AE, Matveeva EA, Romanov BK. Differences between the European and Eurasian Good Pharmacovigilance Practices. Safety and Risk of Pharmacotherapy. 2021;9(2):75–84 (In Russ.). https://doi.org/10.30895/2312-7821-2021-9-2-75-84
2. Kolbin AS, ed. Pharmacovigilance. Moscow: OKI; 2019. (In Russ.).
3. Radecka A, Loughlin L, Foy M, de Ferraz Guimaraes MV, Sarinic VM, Di Giusti MD, et al. Enhancing pharmacovigilance capabilities in the EU regulatory network: the SCOPE joint action. Drug Saf. 2018;41(12):1285–302. https://doi.org/10.1007/s40264-018-0708-5
4. Caster O, Aoki Y, Gattepaille LM, Grundmark B. Disproportionality analysis for pharmacovigilance signal detection in small databases or subsets: recommendations for limiting false-positive associations. Drug Saf. 2020;43(5):479–87. https://doi.org/10.1007/s40264-020-00911-w
5. Montastruc JL, Sommet A, Bagheri H, Lapeyre-Mestre M. Benefits and strengths of the disproportionality analysis for identification of adverse drug reactions in a pharmacovigilance database. Br J Clin Pharmacol. 2011;72(6):905–8. https://doi.org/10.1111/j.1365-2125.2011.04037.x
Supplementary files
Review
For citations:
Matveev A.V., Krasheninnikov A.E., Zelinskaya A.Yu. Signal Management: Updated Requirements of the EAEU Good Pharmacovigilance Practice. Safety and Risk of Pharmacotherapy. 2023;11(1):38-45. (In Russ.) https://doi.org/10.30895/2312-7821-2023-11-1-38-45
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