Катрен Стиль
Минздрав планирует создать реестр фармакопейных стандартных образцов
Министерство здравоохранения предложило начать вести российский реестр фармакопейных стандартных образцов. Проект соответствующего приказа опубликован для публичного обсуждения 25 ноября на портале нормативных актов.
Согласно определению из закона № 61‑ФЗ стандартные образцы ― это «вещества, посредством сравнения с которыми осуществляется контроль качества исследуемых ЛС с помощью физико-химических и биологических методов в целях подтверждения их соответствия требованиям нормативной документации, установленным при регистрации, и которые применяются для калибровки стандартных образцов производителя, используемых для контроля качества и иных целей при обращении лекарственных средств».
Фармакопейный стандартный образец ― это стандартный образец, произведённый в соответствии с фармакопейной статьёй.
Создание реестра может быть обусловлено тем, что зарубежные регуляторы (FDA, EDQM) весной прекратили поставки в Россию импортных стандартных образцов. Таким образом, производителям для контроля качества приходится пользоваться иностранными образцами из сформированных ранее запасов.
По планам Минздрава, ведением этого реестра будет заниматься ФГБУ «Научный центр экспертизы средств медицинского применения», а все данные из него будут размещены в открытом доступе на официальном сайте центра.
Ранее Федеральная служба по надзору в сфере здравоохранения утвердила порядок предоставления сведений о лекарственных препаратах, поступающих в гражданский оборот. С марта следующего года производители должны будут подавать подробную информацию перед вводом серии в оборот, а не после, как это происходит сейчас.
28 ноября 2022
Фото: © IgorVetushko / Фотобанк Фотодженика
Выпуск: №227, ноябрь 2022538 просмотров
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