Suchergebnisse

The article presents the results of a comparative analysis of Goodpharmacovigilance practices (GVP), developed by experts of the regulatory bodiesof the European Union (EU) and the United States. It is shown that the EU GVP cover almost all possible aspects of pharmacovigilance. It is noted that the disadvantages of EU GVP are difficulties in the correct understanding and interpretation of certain definitions and processes, as well as the complexity of the implementation in practice of a number of provisions, mainly related to the organization of the quality management system, including audit and inspection. As the basis for development of the Russian Rules GVP is recommended to use the GVP EU ; В статье представлены результаты сравнительного анализа Надлежащей практики фармаконадзора (GVP), разработанной экспертами регуляторных органов Европейского Союза (EU) и США. Показано, что GVP EU охватывают практически все возможные аспекты фармаконадзора. Отмечено, что недостатками GVP EU являются затруднения в правильном понимании и трактовке некоторых определений и процессов, а также сложности реализации на практике ряда положений, преимущественно касающихся организации системы менеджмента качества, включая аудит и инспекционные проверки. В качестве основы для разработки отечественных Правил GVP рекомендовано использование GVP EU

There are a lot of diseases known today, which are caused by genetic abnormalities. Advances in genetics and biotechnology brought about gene editing technologies that can produce almost any gene, which ultimately led to the emergence of a new class of medicines - gene therapy products (GTPs). The aim of the study was to analyse international experience in development and authorisation of GTPs. The review highlights the challenges in GTP development, related to the search for an optimal approach to therapeutic gene delivery to the target cells. Viral vectors were shown to be a promising gene delivery system, with adenovirus (AV) and adeno-associated virus (AAV) based products demonstrating the highest efficacy and safety. The paper reviews current approaches to gene editing that allow modification of AVs and AAVs to improve GTP efficacy and safety. These modifications are carried out with the aim of, e.g., including a large therapeutic gene into a viral vector, decreasing viral protein expression levels, and decreasing viral vector immunogenicity. The review summarises GTP authorisation procedures in the USA and the European Union, including data on FDA and EMA subcommittees and departments entrusted with advisory functions. The paper mentions that there is one Russian-produced GTP authorised in the Russian Federation, and some other GTPs are in the pipeline. Therefore, the Russian regulatory framework and the Eurasian regulations and recommendations should be updated in order to accommodate for GTP development and authorisation. ; В настоящее время известно большое количество заболеваний, патогенез которых обусловлен генетическими нарушениями. Достижения в области генетики и биотехнологии привели к созданию методов, которые позволяют получить практически любой ген, что в конечном счете привело к появлению нового класса лекарственных средств – генотерапевтических препаратов (ГТП). Цель работы – критический анализ международного опыта создания и регистрации генотерапевтических лекарственных препаратов. В обзоре ...