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Регистрацию препаратов для терапии коронавирусной инфекции будет проверять Совет по этике
Регистрацию препаратов для терапии коронавирусной инфекции будет проверять Совет по этике
Министерство здравоохранения внесло изменения в Положение о Совете по этике Минздрава, которые обязывают Совет оценивать заявки на регистрацию лекарственных препаратов, предназначенных для применения в условиях чрезвычайной ситуации или эпидемии. Соответствующий приказ от 30.04.2020 № 396н опубликован 7 мая на портале раскрытия правовой информации.
Основной задачей Совета по этике при министерстве является проведение этической экспертизы возможности клинических исследований лекарственных препаратов. Совет оценивает возможные этапы и результаты исследований с точки зрения защиты здоровья и прав пациентов, участвующих в исследованиях.
В Совет входят представители медицинских и научных организаций, образовательных учреждений, а также представителей общественных организаций, религиозных организаций и средств массовой информации.
Новый приказ вменяет Совету новую обязанность — проведение этической экспертизы возможности регистрации лекарственных препаратов, которые будут использованы во время чрезвычайных ситуаций или будут применяться для профилактики или лечения заболеваний, представляющих опасность для окружающих.
Напомним, что ранее Правительство России на фоне распространения новой коронавирусной инфекции утвердило новые особенности обращения лекарственных препаратов, предназначенных для противостояния COVID-19. В частности, срок регистрации таких ЛС сокращен в несколько раз, а в ряде случаев появилась возможность не предоставлять подробные отчеты о результатах клинических испытаний.
Теперь для регистрации подобных лекарственных препаратов понадобится также одобрение Совета по этике Минздрава.
8 мая 2020
Фото: depositphotos.com
Выпуск: №196, май 20201860 просмотров
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