Regulatory aspects of preclinical and clinical trials of drugs

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DOI: https://doi.org/10.29296/25419218-2020-06-07
Issue: 
6
Year: 
2020

A.A. Taube Saint Federal state budgetary institution «Scientific center expertise of medical devices» of the Ministry health care of the Russian Federation, Petrovsky b-R, 8, p.2, Moscow, 127051, Russian Federation

Since 2014, the registration dossier in the Russian Federation has been submitted as a general technical document in accordance with the ICH requirements. The recognition of nonclinical and clinical trials conducted according to a single accepted standard in other countries leads to a considerable reduction in the time to market for a new drug. There have been comparative studies of the regulatory requirements for submitting the results of preclinical and clinical trials of drugs to the registration dossier in the United States (US), the European Union (EU), and the Russian Federation (RF). Main differences have been found in terms, requirements for the preparation and execution of documents of the results of nonclinical and clinical trials to the regulatory authorities in the USA, EU, and RF for marketing authorization or registration. A comparative analysis of the requirements for the registration and submission of documents as part of the registration dossier has shown that at the moment the main norms that govern non-clinical and clinical trials in Russia are harmonized with world practice. The main difficulty is the lack of worldwide recognition of the results of studies conducted in Russia. This is due to the fact that Russian laboratories are not accredited for compliance with international requirements. Harmonizing clinical research requirements is the most labor-intensive work. The international organizations WHO and ICH create a regulatory framework for the functioning of a single space for nonclinical and clinical trials.
Keywords: 
state registration of medicines
general technical document
CTD
GLP
GCP
preclinical trials
clinical trials
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