Review of the Certification Procedure for Qualified Persons of Manufacturers of Medicines for Human Use in Russia

Scientific relevance. In December 2020, the Russian Federation adopted the Eurasian Economic Union (EAEU) requirements. This has significantly changed the certification procedure for qualified persons (QPs) of manufacturers of medicinal products for human use in the Russian Federation. To accommodate these changes, the Russian regulatory framework needs further improvement.Aim. This study aimed to review the changes made to the mechanism of state regulation of medicines and to evaluate the impact on the pharmaceutical industry two years after the adoption of the current QP certification procedure.Discussion. This review compares two QP certification procedures established by Order No. 7n of the Ministry of Health of the Russian Federation dated 12 January 2021. The first is an abbreviated one for QPs certified under the previous procedure, and the second is an initial one for QPs being certified for the first time, having an expired certificate, or wishing to extend their professional qualification profiles. The article illustrates common mistakes made by certification applicants when preparing their documents. Furthermore, the authors describe the most prevalent knowledge gaps identified by testing. The abbreviated certification procedure ensured a sufficiently smooth transition to the EAEU requirements. For example, by 1 February 2023, 506 QPs were recertified for the next five-year period according to this procedure. This accounts for slightly more than half of all QPs certified in the Russian Federation according to the previous requirements. The total number of QPs certified according to the EAEU requirements in Russia in 2021–2022 is approximately 1.5 times higher than the number of QPs certified during the same period in 2014–2015.Conclusions. The updated procedure for QP certification has noticeably changed the occupational group of QPs formed in the Russian Federation in the last decade. The implementation of the new QP certification procedure has revealed several procedural issues that require additional explanation and clarification by the Ministry of Health of the Russian Federation

Аналитический обзор процедуры аттестации уполномоченных лиц производителей лекарственных средств для медицинского применения в России

Scientific relevance. In December 2020, the Russian Federation adopted the Eurasian Economic Union (EAEU) requirements. This has significantly changed the certification procedure for qualified persons (QPs) of manufacturers of medicinal products for human use in the Russian Federation. To accommodate these changes, the Russian regulatory framework needs further improvement.Aim. This study aimed to review the changes made to the mechanism of state regulation of medicines and to evaluate the impact on the pharmaceutical industry two years after the adoption of the current QP certification procedure.Discussion. This review compares two QP certification procedures established by Order No. 7n of the Ministry of Health of the Russian Federation dated 12 January 2021. The first is an abbreviated one for QPs certified under the previous procedure, and the second is an initial one for QPs being certified for the first time, having an expired certificate, or wishing to extend their professional qualification profiles. The article illustrates common mistakes made by certification applicants when preparing their documents. Furthermore, the authors describe the most prevalent knowledge gaps identified by testing. The abbreviated certification procedure ensured a sufficiently smooth transition to the EAEU requirements. For example, by 1 February 2023, 506 QPs were recertified for the next five-year period according to this procedure. This accounts for slightly more than half of all QPs certified in the Russian Federation according to the previous requirements. The total number of QPs certified according to the EAEU requirements in Russia in 2021–2022 is approximately 1.5 times higher than the number of QPs certified during the same period in 2014–2015.Conclusions. The updated procedure for QP certification has noticeably changed the occupational group of QPs formed in the Russian Federation in the last decade. The implementation of the new QP certification procedure has revealed several procedural issues that require additional explanation and clarification by the Ministry of Health of the Russian Federation.Актуальность. Порядок аттестации уполномоченных лиц производителей лекарственных средств для медицинского применения (УЛ) с декабря 2020 г. претерпел существенные изменения в связи с переходом на требования Евразийского экономического союза (ЕАЭС). Актуальной является необходимость дальнейшего совершенствования соответствующей нормативной базы в российском законодательстве.Цель. Анализ изменений в механизме государственного регулирования сферы обращения лекарственных средств, произошедших за два года применения нового порядка аттестации уполномоченных лиц, и оценка влияния этих изменений на фармацевтическую отрасль.Обсуждение. Представлены результаты сравнительного анализа двух административных процедур аттестации УЛ, установленных приказом Минздрава России от 12.01.2021 № 7н: ускоренной (для УЛ, аттестованных ранее) и первичной (для УЛ, аттестуемых впервые; для УЛ, срок действия аттестации которых истек; в случае необходимости расширения производственных специализаций УЛ). Приведены типичные ошибки заявителей при оформлении документов, описаны наиболее распространенные пробелы знаний заявителей, выявляемые при тестовом контроле. Отмечено, что использование ускоренной процедуры аттестации позволило достаточно плавно осуществить переход на требования к УЛ в ЕАЭС. Так, по состоянию на 01.02.2023 по данной процедуре на новый пятилетний период было заново аттестовано 506 человек, чуть более половины всех ранее аттестованных УЛ в Российской Федерации. Общее количество аттестованных в качестве УЛ за период 2021–2022 гг. выросло в 1,5 раза в сравнении с таким же периодом в 2014–2015 гг.Выводы. Отмечено, что введение обновленного порядка аттестации в Российской Федерации привело к заметным изменениям сформированной в последнее десятилетие профессиональной группы УЛ. При анализе нормативной базы выявлен ряд процедурных вопросов, которые требуют дополнительных уточнений и разъяснений Минздрава России при применении действующего порядка аттестации УЛ

Analgesic and anti-inflammatory activity of vanillin derivatives

The analgesic activity of 4-hydroxy-3-methoxybenzaldehyde (vanillin) derivatives with different pharmacophore groups were studied in vivo in models of chemically induced pain induced by subplantar administration of the TRP ion channel agonists capsaicin and allylisothiocyanate. The anti-inflammatory actions of vanillin derivatives were demonstrated in a model of carrageenan-induced edema. The analgesic and anti-inflammatory activities of vanillin and its derivatives were studied; these are linked with the effects of these substances on TRPA1 and TRPV1 receptors

THYMOL ESTER OF GAMMA-AMINOBUTYRIC ACID: SYNTHESIS AND ANTICONVULSANT ACTIVITY

Thymol ester of gamma-aminobutyric acid (GABA) − 2-isopropyl-5-methylphenyl 4-aminobutyrate hydrochloride − was synthesized via Steglich esterification and characterized by 1H NMR, IR and mass spectral studies. The anticonvulsant activity of obtained compound was estimated over a wide range of doses 5-80 mg/kg by determining the minimum effective doses of pentylenetetrazole inducing clonic-tonic convulsions and tonic extension. Present findings indicate that thymol ester of GABA is not a classical prodrug and possesses its own pharmacological activity. Prolonged antiseizure action of thymol derivative (20 mg/kg) was revealed at 24 hours after oral administration. Furthermore, orally co-administered gidazepam (1 mg/kg) and thymol ester of GABA (20 mg/kg) produce synergistic effect in seizures prevention

Analgesic and anti-inflammatory activity of vanillin derivatives

Анальгетическая активность производных 4-гидрокси-3-метоксибензальдегида (ванилина) с различными фармакоформными группами изучена in vivo на моделях химически-индуцированной боли, вызванной субплантарным введением агонистов TRP ионных каналов – капсаицина и аллилизотиоцианата. Противовоспалительное действие производных ванилина продемонстрировано на модели каррагинан-индуцированной отека. Исследована анальгетическая и противовоспалительная активность ванилина и его производных, которая связана с влиянием указанных веществ на TRPA1 и TRPV1 рецепторы.The analgesic activity of 4-hydroxy-3-methoxybenzaldehyde (vanillin) derivatives with various pharmacophore groups has been studied in vivo on models of chemically induced pain caused by subplantar injection of TRP ion channel agonists – capsaicin and allylisothiocyanate. The anti-inflammatory effect of vanillin derivatives has been demonstrated on a carrageenan-induced edema model. The analgesic and anti-inflammatory activity of vanillin and its derivatives was established and associated with the influence of these compounds on TRPA1 and TRPV1 receptors