Регуляторное качество в международном обращении лекарственных средств

С 2014 г. Всемирная организация здравоохранения (ВОЗ) реализует мас- штабный проект по укреплению и развитию национальных регуляторных систем в сфере обращения лекарственных средств, который направлен на повышение доступности безопасных, эффективных и качественных лекарственных средств и медицинских изделий для населения всех стран, но в первую очередь стран с низким и средним доходом. В рамках проекта анализируется зрелость национальных регуляторных систем с помощью глобального инструмента бенчмаркинга, разработанного на основе различных систем оценивания регуляторных органов и прошедшего широкое обсуждение и пилотное тестирование. Результаты национальных органов, достигших высоких уровней зрелости, публикуются. Также формируется Перечень ВОЗ регуляторных органов, замещающий ранее использовавшуюся концепцию регуляторных органов с высокими требованиями. Указанный Перечень рекомендуется использовать в процедурах регуляторного доверия национальными регуляторными органами, закупочными структурами различного уровня и статуса – коммерческими, общественными, государственными или международными. Качество государственного регулирования фармацевтического сектора является одним из критических факторов всей национальной системы здравоохранения. Рассматриваемый проект ВОЗ по оценке функциональности (зрелости) регуляторной системы фармацевтического сектора принципиально отличается от осуществлявшихся в прошлом проектов аналогичной направленности. Прежде всего в рамках проекта акцент сделан не на правовые и нормативно-методические документы, а на институциональные и процедурные аспекты, т.е. на структуру и функции регуляторных органов. Наряду с этим проект может оказать существенное влияние на мировые фармацевтические рынки.

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