Development of an Approach to the Assessment of Changes to Approved Biological Products

The need to strengthen the post-approval regulation of biological products stems from their increasing role in the treatment of serious human diseases. Until recently, there were open questions on the classification of changes and supporting data necessary to confirm the comparability of a biological medicinal product before and after any changes, as well as on the procedures and deadlines for the submission and approval of variations. In October 2017 the WHO Expert Committee on Biological Standardisation developed and published the «Guidelines on procedures and data requirements for changes to approved biotherapeutic products». The WHO recommendations are primarily aimed at resolving the complexities and current problems in the global life cycle management of biotherapeutic products. Guidelines suggest approaches that ensure continued quality, efficacy, and safety of this group of products, as well as continuity in supply and access. The purpose of this paper was to analyse the WHO recommendations on post-approval changes to biotherapeutic products in order to develop harmonised approaches to the assessment of post-approval changes to biological medicinal products in the Russian Federation. The categories of quality changes, supporting data, conditions to be fulfilled, procedures and deadlines set forth in this paper can serve as a basis for further improvement of the national regulatory and methodological framework

Формирование подхода к оценке пострегистрационных изменений биологических лекарственных средств

The need to strengthen the post-approval regulation of biological products stems from their increasing role in the treatment of serious human diseases. Until recently, there were open questions on the classification of changes and supporting data necessary to confirm the comparability of a biological medicinal product before and after any changes, as well as on the procedures and deadlines for the submission and approval of variations. In October 2017 the WHO Expert Committee on Biological Standardisation developed and published the «Guidelines on procedures and data requirements for changes to approved biotherapeutic products». The WHO recommendations are primarily aimed at resolving the complexities and current problems in the global life cycle management of biotherapeutic products. Guidelines suggest approaches that ensure continued quality, efficacy, and safety of this group of products, as well as continuity in supply and access. The purpose of this paper was to analyse the WHO recommendations on post-approval changes to biotherapeutic products in order to develop harmonised approaches to the assessment of post-approval changes to biological medicinal products in the Russian Federation. The categories of quality changes, supporting data, conditions to be fulfilled, procedures and deadlines set forth in this paper can serve as a basis for further improvement of the national regulatory and methodological framework.Необходимость усиления пострегистрационного регулирования в сфере обращения биологических лекарственных средств связана с возрастанием их роли в терапии серьезных заболеваний человека. До последнего времени оставались открытыми вопросы, касающиеся классификации изменений и вспомогательных данных, необходимых для подтверждения сопоставимости биологического лекарственного средства до и после внесения изменений, а также процедур и сроков одобрения изменений. В октябре 2017 г. Экспертный совет по стандартизации биологических препаратов ВОЗ разработал и опубликовал «Руководство по процедурам и требованиям к данным для внесения изменений в зарегистрированные биотерапевтические препараты», целью которых стало разрешение сложностей и текущих проблем в глобальном управлении жизненным циклом биотерапевтических лекарственных препаратов. В данном документе изложены подходы, обеспечивающие постоянство качества, эффективности, безопасности, гарантию непрерывности обращения и доступности этой группы лекарственных препаратов населению. Цель работы — анализ рекомендаций ВОЗ в области пострегистрационных изменений биотерапевтических лекарственных препаратов для рассмотрения гармонизированных подходов к оценке изменений биологических лекарственных средств после их регистрации в Российской Федерации. Классификация изменений качества, вспомогательные данные, процедуры и сроки, изложенные в работе, могут быть взяты за основу дальнейшего совершенствования национального регулирования и методической базы

IMI : global trends in myopia management attitudes and strategies in clinical practice : 2022 update

PURPOSE. Surveys in 2015 and 2019 identified a high level of eye care practitioner concern/activity about myopia, but the majority still prescribed single vision interventions to young myopes. This research aimed to provide updated information. METHODS. A self-administered, internet-based questionnaire was distributed in 13 languages, through professional bodies to eye care practitioners globally. The questions examined awareness of increasing myopia prevalence, perceived efficacy and adoption of available strategies, and reasons for not adopting specific strategies. RESULTS. Of the 3195 respondents, practitioners’ concern about the increasing frequency of pediatric myopia in their practices differed between continents (P < 0.001), being significantly higher in Asia (9.0 ± 1.5 of 10) than other continents (range 7.7–8.2; P ≤ 0.001). Overall, combination therapy was perceived by practitioners to be the most effective method of myopia control, followed by orthokeratology and pharmaceutical approaches. The least effective perceived methods were single vision distance undercorrection, spectacles and contact lenses, as well as bifocal spectacles. Practitioners rated their activity in myopia control between (6.6 ± 2.9 in South America to 7.9 ± 1.2/2.2 in Australasia and Asia). Single-vision spectacles are still the most prescribed option for progressing young myopia (32.2%), but this has decreased since 2019, and myopia control spectacles (15.2%), myopia control contact lenses (8.7%) and combination therapy (4.0%) are growing in popularity. CONCLUSIONS. More practitioners across the globe are practicing myopia control, but there are still significant differences between and within continents. Practitioners reported that embracing myopia control enhanced patient loyalty, increasing practice revenue and improving job satisfaction

Energy-conserving synthesis of nanodispersed amorphous sodium silicate for water-glass production

An energy-conserving, ecologically clean technology for producing water glass has been developed. This technology is based on the use of readily available raw materials. A glassmaking furnace is not usedyesBelgorod State Universit

Energy-conserving synthesis of nanodispersed amorphous sodium silicate for water-glass production

yesAn energy-conserving, ecologically clean technology for producing water glass has been developed. This technology is based on the use of readily available raw materials. A glassmaking furnace is not usedBelgorod State Universit

Актуальні питання надання медичної допомоги юнацькому контингенту

The evaluation of the system of training young men for military service is conducted. The data of primary medical records, the results of preventive medical examinations and the organization of medical-diagnostic process of the present contingent is analyzed. It is proposed organizational and methodological treatments and also preventive measures with the aim of improvement of the medical support of adolescent population and their health improvement. Key words: juvenile contingent, medical support, baseline medical examination. Проведена оценка системы подготовки юношей к военной службе. Проанализированы данные первичной медицинской документации, результаты профилактических медицинских осмотров и организация лечебно-диагностического процесса данного контингента. Предложены организационнометодические и лечебно-профилактические мероприятия с целью усовершенствования медицинского обеспечения подросткового населения и повышения уровня его здоровья. Ключевые слова: юношеский контингент, медицинское обеспечение, профосмотр. Проведено оцінку системи підготовки юнаків до військової служби. Проаналізовано дані первинної медичної документації, результати профілактичних медичних оглядів та організацію лікувально-діагностичного процесу даного контингенту. Запропоновано організаційно-методичні та лікувально-профілактичні заходи з метою удосконалення медичного забезпечення підліткового населення та підвищення рівня його здоров'я. Ключові слова: юнацький контингент, медичне забезпечення, профогляд.