Катрен Стиль
Новые ЛС могут начать регистрировать без клинических испытаний
Требования о проведении клинических испытаний при государственной регистрации могут быть отменены для инновационных лекарственных препаратов. Об этом 22 августа пишет ТАСС со ссылкой на заявление члена комитета Совета Федерации по социальной политике Владимира Круглого.
В Совфеде готовят законопроект, который разрешит не проводить клинические испытания инновационных препаратов (с новыми молекулами), если до этого препарат уже был зарегистрирован в одной из стран с «развитой регуляторикой» с проведением необходимых клинических исследований. Подобные исключения в настоящий момент действуют только при регистрации орфанных препаратов.
Кроме этого, клинические испытания могут не потребоваться для препаратов, проходящих процедуру повторной регистрации. Так, по словам сенатора, в законопроекте рассматривается вариант введения пострегистрационных мер, когда клинические испытания проводятся после выдачи свидетельства о регистрации и введения ЛС в оборот.
Как уточнил Владимир Круглый, под странами с «развитой регуляторикой» подразумеваются члены Международного совета по согласованию технических требований к фармацевтическим препаратам для человека (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, ICH). В него входят такие страны, как США, Япония, Южная Корея, Швейцария, Китай, Канада и другие.
Законодательство о контроле за проведением клинических испытаний лекарственных препаратов в зарубежных странах может сильно различаться. Так, например, в Китае за подделку результатов испытаний ЛС полагается тюремный срок или смертная казнь.
23 августа 2019
Фото: depositphotos.com
Выпуск: №187, август 20191875 просмотров
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