Alfiia Imanaeva
Tatchempharmpreparaty, Russia
Title: Novelties of pharmacovigilance legislation in Eurasian Economic Union
Biography
Biography: Alfiia Imanaeva
Abstract
Abstract
Eurasian Economic Union (EAEU) was established in 2014 and includes Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia. These countries are on the way to share legislation on preclinical and clinical trials, marketing authorization, manufacturing, distribution, pharmacovigilance, etc. The supranational legislation takes precedence over the local one and currently much effort is being made to harmonize them. First edition of EAEU Good practices was issued in 2016. Good pharmacovigilance practice was then updated in 2022 (EAE Commission Council decisions 87 and 81, respectively). The modules of EAEU GVP correspond to EU GVP modules and share the major idea of contributing to the protection of patients’ and public health.
The first revision guided the formation of pharmacovigilance systems of Marketing authorization holders, its assembly from separate parts, like PSURs, SOPs, educational activities, etc. Juxtaposition of the two revisions showed an increase of the document’s size by 1,5 times. Further calculations showed that this increase was due to 2 modules: Adverse reactions and Signal management. It is rational, that once the system is built, we can delve into the cornerstone of pharmacovigilance–safety information management. This line was supported by recent release of the Decision on formation of the EAEU adverse events database that will unite local databases of 5 states. Regarding RMPs and PSURs, their content was somewhat detailed and clarified. The submission of PSURs tends to be less frequent, which is closer to EMA legislation, whereas submission of RMPs was emphasized at the moment–in order to form an EAEU database of publicly available summaries. Interaction options between the manufacturer and authorized bodies have been expanded.
This brief observation period proved that pharmacovigilance can receive effectual development in conditions of wise legislation, industry alacrity and a generous share of publicity and dialogue.