Abstract
The article deals with aprocedure of clinical trial of medical product for human use and describes regulatory aspects of а clinical trial in case of emergency, including the COVID-19 pandemic, analyses the grounds and conditions of studding properties of medical product, passed the state registration, for off-label use, without post-marketing clinical trial (low-interventional study). An assessment is made of the streamlined procedure of the registration of medical products, referring for the prophylactic and treatment of the diseases incase of emergency, andit is concluded about necessity ofextension this proceduretomedical products, which can be used for the treatment of other types of diseases.
Highlights
Стратегия развития иммунопрофилактики инфекционных болезней на период до 2035 г.1 выделяет в качестве основной задачи стимулирование научных разработок, доклинических и клинических исследований в области создания иммунобиологических препаратов
The article deals with aprocedure of clinical trial of medical product for human use and describes regulatory aspects of а clinical trial in case of emergency, including the COVID-19 pandemic, analyses the grounds and conditions of studding properties of medical product, passed the state registration, for off-label use, without post-marketing clinical trial
An assessment is made of the streamlined procedure of the registration of medical products, referring for the prophylactic and treatment of the Родина А
Summary
Стратегия развития иммунопрофилактики инфекционных болезней на период до 2035 г.1 выделяет в качестве основной задачи стимулирование научных разработок, доклинических и клинических исследований в области создания иммунобиологических препаратов. Правовые особенности проведения клинических исследований в современных чрезвычайных условиях
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