THE REGULATORY FRAMEWORK FOR CLINICAL TRIALS IN THE WORLD AND IN RUSSIA

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DOI: https://doi.org/10.29296/25419218-2018-08-01
Issue: 
8
Year: 
2018

A.V. Alikov, S.D. Marchenko I.M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia; 8, Trubetskaya St., Build. 2, Moscow 119991, Russia

In 1964, the World Health Organization (WHO) developed the Declaration of Helsinki as a set of ethical principles for clinical trials and an expansion of many aspects first formulated in the Nuremberg Code in 1946-1947. Since its publication, the Declaration of Helsinki has been revised 9 times due to the gradual accumulation of knowledge and experience with clinical trials. The main positions of the Declaration of Helsinki complemented the Manual on Medical Ethics of Biomedical Research involving human participants, which had been developed by the Council for International Organizations of Medical Science. Since the late 1990s, a guidance published in accordance with the resolution of the International Conference on Harmonization (ICH) has become an official document that regulates clinical trials in the European Union, the USA, and Japan. The guidance included the key principles of two Good Clinical Practices (GCP) developed by the Committee on Patent Medicines of the European Union and the WHO. In 1998, Russia published Branch Standard (OST) 42-511-99 «Rules for quality clinical trials in the Russian Federation», which complied with many GCP principles. Later, in 2005, State Standard (GOST) R 52379-2005 «The National Standard of the Russian Federation. GCP» was published. It was a translation of an ICH-GCP version as of that time. Currently, the main law regulating the procedure of clinical trials in the Russian Federation is Federal Law No. 61-FZ «On Circulation of Medicines» (2010), Chapter 7 of which is devoted to clinical trials of drugs for medical use. The basic principles of clinical trials are set out in detail in the «Guide to the Examination of Medicines» (2013). Within the framework of the Eurasian Economic Union (EAEU) established in 2014, a decision was made to form a common market for medicines and to publish common guidelines for the pharmaceutical industry, which does not cancel the existing national rules. Thus, at the moment, the national legislation and regulations of the EAEU are in force simultaneously, which in some cases have fundamental differences that affect the tactics of clinical trials.
Keywords: 
clinical trials
Declaration of Helsinki
International Conference on Harmonization
Good Clinical Practice
Eurasian Economic Union
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