The pharmacovigilance system plays one of the key roles in ensuring safety and efficacy of medicine use. The risk management process helps to ensure the most favourable benefit/risk ratio of a medicine or combination of medicines both for the target populations and the general public. Unavailability of a risk management process for medicines may adversely affect the health of the general population. One of the major documents in medicine risk management is the risk management plan (RMP).The aim of the study was to analyse compliance of RMPs submitted as part of registration dossiers with the requirements of the Eurasian Economic Union (EAEU), and to analyse problems arising during their preparation.Materials and methods: the authors analysed 200 RMPs submitted from January 1 until August 31, 2021.Results: it was determined that the most frequent mistakes made by pharmacovigilance officers are related to medicine summaries in RMPs covering several medicines, medicine safety specification parts of RMPs, description of risks in the pharmacovigilance plan and description of risk minimisation measures, and insufficient representation of the key elements of the medicine efficacy and safety overview in the RMP summary. For instance, RMPs often lack information on the epidemiology of indications for target populations in the EAEU, or RMPs may lack some of the major risks reflected in the patient information leaflets, or lack assessment of safety risk minimisation actions, etc.Conclusions: proper preparation of RMPs that would comply with the EAEU Good Pharmacovigilance Practice is inconceivable without further professional training of pharmacovigilance officers.

The experts of the Scientific Centre for Expert Evaluation of Medicinal Products analysed administrative decisions of foreign regulatory authorities on the recalls of antibacterial and antiprotozoal medicinal products and/or the need for labelling updates due to changes in the safety profile. The analysis revealed 16 decisions containing information on the following medicines registered in Russia: ertapenem, сeftriaxone, cefazolin, аmoxicillin, сefoperazone+sulbactam, piperacillin+tazobactam, сlindamycin, teicoplanin, rifampin, co-trimoxazole, hydroxychloroquine.

В соответствии с Решением Совета Евразийской экономической комиссии от 19.05.2022 № 81 «О внесении изменений в Правила надлежащей практики фармаконадзора Евразийского экономического союза» 6 декабря 2022 г. вступила в силу новая редакция Правил надлежащей практики фармаконадзора (GVP) Евразийского экономического союза (ЕАЭС). Одним из ключевых документов системы фармаконадзора, предоставляемым в составе регистрационного досье лекарственного препарата, является план управления рисками (ПУР). Цель работы: провести экспертный анализ изменений требований Правил GVP ЕАЭС к структуре, содержанию и порядку представления ПУР для лекарственных препаратов. Результаты проведенного анализа показали, что в требования, предъявляемые уполномоченными органами в области обращения лекарственных средств к документу о системе управления рисками для лекарственного препарата в ЕАЭС, внесены существенные изменения. В частности, уточнены и расширены требования к информационному наполнению частей и модулей ПУР. Введено требование обязательного соответствия между информацией, приведенной в модулях и частях ПУР и в модулях регистрационного досье лекарственного препарата. Представлено подробное описание, при каких условиях, процедурах и в каких исключительных ситуациях держателю регистрационного удостоверения необходимо представлять ПУР в составе регистрационного досье. Новые требования позволят держателям регистрационных удостоверений усовершенствовать и оптимизировать процесс управления рисками.Ключевые слова: план управления рисками; фармаконадзор; регистрация лекарственных средств; Правила надлежащей практики фармаконадзора; Евразийский экономический союз; GVP ЕАЭС; держатель регистрационного удостоверения

The search for an effective and safe COVID-19 therapy involves, among other things, assessment of efficacy of medicines already used for the treatment of other diseases, and having potential antiviral activity against SARS-CoV-2. The relevance of the presented study stems from ambiguous data on the off-label use of the antiparasitic medicine ivermectin for the treatment of COVID-19 patients. The aim of the study was to analyse ivermectin efficacy and safety for COVID-19 treatment, as reflected in the scientific literature. Ivermectin, an antiparasitic medicine from the group of macrocyclic lactones produced by Streptomyces avermitilis, stimulates release of the inhibitory neurotransmitter gamma-aminobutyric acid, which leads to impaired transmission of nerve impulses, paralysis and death of parasites. The results of preclinical studies show ivermectin’s inhibitory activity against a number of RNA and DNA viruses, including SARS-CoV-2. The results of ivermectin clinical studies are ambiguous: a number of studies demonstrated a positive effect on the condition of COVID-19 patients, however, there is currently no convincing evidence of the validity and efficacy of ivermectin use for the prevention and treatment of COVID-19 patients. The safety profile of ivermectin is relatively favourable. Large randomised controlled trials are needed to fully assess the feasibility of using ivermectin in COVID-19.