Катрен Стиль
Правительство продлило регистрацию препаратов для борьбы с коронавирусом
Срок действия регистрационных удостоверений, выданных по ускоренной процедуре, предназначенной для лекарственных препаратов для применения в условиях чрезвычайной ситуации или борьбы с опасными заболеваниями, продлён до 2024 года. Соответствующее Постановление Правительства РФ от 30.12.2022 № 2537 опубликовано 31 декабря.
Напомним, что в 2020 году, в начале пандемии коронавируса, правительством были утверждены специальные правила регистрации лекарственных средств, предназначенных для применения в условиях чрезвычайной ситуации, а также для профилактики и лечения заболеваний, представляющих опасность для окружающих. Согласно этому документу время регистрации препаратов для борьбы с COVID-19 можно было сократить со 120 до 20 рабочих дней.
Для этого производителям таких ЛС разрешено вместо подробных отчётов о результатах клинических исследований предоставить краткий отчёт об имеющихся на момент подачи заявления результатах изучения эффективности и безопасности лекарственного препарата в рамках КИ.
В документе прописано, что срок действия выданных по такой схеме регистрационных удостоверений ограничен. По его истечению производители должны перерегистрировать препарат по стандартным правилам, предоставив полный пакет необходимых документов.
Изначально планировалось, что такие регудостоверения будут действовать до 2021 года. Затем их срок действия был увеличен ещё на один год. Позже срок был увеличен до 2023 года. Теперь срок регистрации таких ЛС продлён до 31 декабря 2023 года. До этой даты будут действовать и сами правила ускоренной регистрации.
В июле прошлого года правительство также разрешило производителям вакцин для профилактики коронавируса продлевать срок годности своих препаратов, зарегистрированных в ускоренном порядке.
9 января 2023
Фото: © RodicaCiorba / Фотобанк Фотодженика
Выпуск: №229, январь 2023500 просмотров
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