Катрен Стиль
Итоги работы Росздравнадзора за полгода: изъято 238 серий препаратов
21 июля Федеральная служба по надзору в сфере здравоохранения опубликовала отчет о результатах государственного контроля в сфере обращения ЛС за 1‑е полугодие 2020 года. Мы публикуем выдержки из официального сообщения, содержащие наиболее интересные цифры и тренды.
Так, в результате проведенных Росздравнадзором мероприятий за 1‑е полугодие 2020 года было изъято из обращения 238 серий лекарственных средств, качество которых не отвечает установленным требованиям. Большую часть из них составляют недоброкачественные лекарственные препараты (95 серий) и ЛС, отозванные производителями или импортерами (135 серий).
Интересно, что за последние пять лет объемы изъятия препаратов с рынка неуклонно снижаются:
Схожая динамика (за исключением 2018 года) наблюдается и в отношении выявления недоброкачественных ЛС в обороте:
Интересно, что на первом месте среди показателей «несоответствия качества» лекарств стоит формальный параметр — «Описание».
Таблица: Структура показателей несоответствия качества ЛС промышленного (не аптечного) производства, изъятых из обращения за 1‑е полугодие 2020 года (по количеству серий)
| Показатель несоответствия | Доля, % |
| Описание | 13 |
| Количественное определение | 13 |
| Подлинность | 11,8 |
| Посторонние примеси | 8 |
| Упаковка | 7 |
| Механические включения | 6 |
| Белок/общий белок | 4,2 |
| Другие показатели | 37 |
Еще один позитивный тренд, содержащийся в отчете регулятора, — это планомерное снижение количества фальсифицированных препаратов на рынке:
Полную версию отчета вы можете изучить по этой ссылке. Напомним, что ранее на этой неделе вышла новая версия проекта приказа Минздрава «Об утверждении индикаторов риска нарушения обязательных требований … для определения необходимости проведения внеплановых проверок … в сфере обращения лекарственных средств». Она содержит всего один «индикатор риска» вместо десяти изначальных.
22 июля 2020
Фото: depositphotos.com
Выпуск: №198, июль 20202452 просмотров
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