АНАЛИЗ МЕЖДУНАРОДНЫХ ТРЕБОВАНИЙ К КОМПЛЕКСНОМУ ПРОЕКТИРОВАНИЮ КЛИНИЧЕСКИХ ИССЛЕДОВАНИЙ ЛЕКАРСТВЕННЫХ СРЕДСТВ

При проведении анализа международных требований к комплексному проектированию клинических исследований лекарственных средств было установлено, что глобальным документом являются стандарты ICH; на национальном уровне в Российской Федерации данным стандартом является ГОСТ Р 52379 -2005 «Над лежащая клиническая практика», текст которого идентичен руководству по над лежащей клинической практике (Consolidated Guideline for Good Clinical Practice). Детализированные международные требования, регламентирующие различные аспекты проведения клинических исследований, разрабатываются глобальными регуляторами: FDA и EMA. В настоящее время в Российской Федерации отсутствуют локальные нормативные документы, регламентирующие проектирование клинических исследований лекарственных средств, в этой связи с большой долей вероятности можно говорить о необходимости разработки национальных документов, регламентирующих различные аспекты планирования клинических исследований, и синхронизации данной нормативной базы с международными документами с целью обеспечения эффективного выхода отечественных лекарственных средств на зарубежные рынки.

проектирование клинических исследований, гармонизация, нормативные требования

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