STATE CONTROL OVER CIRCULATION OF MEDICINES: THE STAGE OF PRECLINICAL TRIALS

Introduction. Preclinical trials (PCTs) as one of the stages of the drug life cycle are conducted in accordance with good laboratory practice (GLP). GLP is a quality system that deals with the organization of the process and the conditions under which it is planned to conduct, as well as to monitor, record, and archive the results of PCTs. GLP is designed to standardize and unify all PCTs, by using standard and validated methods and procedures. The carefully controlled conditions and processes allow one to obtain results that meet the criteria for reproducibility and tracking of data acquisition. The task of regulatory authorities is to monitor (inspect) research centers (RCs) for compliance with the requirements of the GLP regulations in order to ensure the proper performance of PCTs of drug candidates. Objective: to study of the principles of monitoring the assessment of the compliance of RCs with the GLP requirements, as well as the results of these assessments by regulatory authorities. Material and methods. The materials were foreign and Russian regulatory documents, accounting documents of the Federal Health Service of Russia and the US Food and Drug Administration. The study used information and analytical methods, retrospective and content analysis. Results. The methodological approaches to regulating the RCs conducting drug PCTs in the Russian Federation were studied. The report documents on making inspections in Russia and the United States were analyzed. The number and nature of violations were investigated according to the defined criteria. Conclusion. The analysis of the regulation of RCs in the Russian Federation has shown the compliance with the formal WHO indicators for assessing the activities of national regulators in drug circulation. It has been found that in Russia there are no accreditation requirements for conducting drug PCTs. There are general accreditation requirements for laboratory activities in any field, which are confirmed for each type of activity and include methods and test objects. A laboratory can conduct PCTs within the obtained accreditation framework. The results have indicated that much more inspections are made in the Russian Federation than in the United States.

GLP, good laboratory practice, GLP, management, expert assessment, statutory regulation