Катрен Стиль
Выход дженериков на рынок ускорят с помощью новых штрафов
Минздрав опубликовал проект поправок к Кодексу об административных правонарушениях, которые вводят штрафы для юридических лиц за отказ предоставить образцы биотехнологического или орфанного препарата для проведения клинических исследований референтного препарата. Таким образом ведомство планирует сократить возможный срок выхода воспроизведенных препаратов на рынок. Текст поправок был официально опубликован 25 сентября.
В настоящий момент по закону регистрация воспроизведенных лекарственных средств возможна лишь спустя 4 года по окончании срока регистрации референтного препарата. При этом ни один нормативный акт не устанавливает запрета на проведение клинических испытаний воспроизведенных ЛС до истечения патента оригинала.
Поскольку результаты испытаний должны быть предоставлены до момента подачи заявления на регистрацию, в Минздраве считают, что проведение клинических исследований дженерика до истечения срока регистрации референтного препарата позволит уменьшить время выхода на рынок воспроизведенных ЛС.
За отказ держателей регистрационных удостоверений биотехнологических или орфанных препаратов предоставлять образцы своих ЛС для проведения клинических испытаний ведомство предлагает установить штраф в размере 100 тысяч рублей.
Напомним, что ранее члены Совета по правам человека при Президенте РФ рекомендовали властям тщательней контролировать рынок дженериков. В частности, общественники обращают внимание на степень эффективности воспроизведенных препаратов в сравнении с оригинальными.
26 сентября 2018
Фото: depositphotos.com
Выпуск: №176, сентябрь 20181976 просмотров
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