State control over circulation of medicines: the stage of preclinical trials

Download full text PDF
DOI: https://doi.org/10.29296/25419218-2021-03-09
Issue: 
3
Year: 
2021

A.A. Taube Research Center for Examination of Medical Products, Ministry of Health of the Russian Federation, 8, Petrovsky Boulevard, Build. 2, Moscow, 127051, Russian Federation Saint Petersburg State Chemical Pharmaceutical University, 14, Prof. Popov St., Saint Petersburg 197376, Russian Federation

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.
Keywords: 
good laboratory practice
GLP
management
expert assessment
statutory regulation
References: 
  1. Jena Sapana Chavan G.B. Implementation of Good Laboratory Practices (GLP) in basic scientific research: Translating the concept beyond regulatory compliance Regulatory Toxicology and Pharmacology. 2017; 89: 20–5. DOI:10.1016/j.yrtph.2017.07.010
  2. Zscharnack M., Krause S., Aust G. et al. Preclinical good laboratory practice-compliant safety study to evaluate biodistribution and tumorigenicity of a cartilage advanced therapy medicinal product (ATMP). J. of Translational Medicine. 2015; 13: 160. DOI: 10.1186/s12967-015-0517-x
  3. Begley S.G., Ioannidis J.P. A Reproducibility in Science: Improving the Standard for Basic and Preclinical Research. Circulation Research. 2015; 116 (1): 116–26. DOI: 10.1161/CIRCRESAHA.114.303819
  4. McCarty L.S., Borgert, C.J., Mihaich, E.M. Information quality in regulatory decision making: Peer review versus good laboratory practice. Environmental Health Perspectives. 2012; 120 (7): 927–34. DOI: 10.1289/ehp.1104277
  5. Trapkova A.A., Vrubel' M.E. Gosudarstvennyj kontrol' za provedeniem doklinicheskih i klinicheskih issledovanij lekarstvennyh sredstv dlja meditsinskogo primenenija. Vestnik Roszdravnadzora. 2019; 2: 50–5. [Trapkova A.A., Vrubel' M.E. State control over the conduct of preclinical and clinical studies of medicines for medical use. Vestnik Roszdravnadzora. 2019; 2: 50–5 (in Russian)]
  6. Vel'ts N.Ju. Aljautdin R.N., Kazakov A.S. i dr. Pravila nadlezhaschej laboratornoj praktiki. Bezopasnost' i risk farmakoterapii. 2016; 1: 28–32. [Vel'ts N.Yu., Alyautdin R.N., Kazakov A.S. et al. The rules of good laboratory practice. Bezopasnoct' i risk farmakoterapii. 2016; 1: 28–32 (in Russian)]
  7. Zajtseva M.A., Ivanov M.B., Pikalova L.V., Kashina T.V. Tseli i politika kachestva pri provedenii doklinicheskih issledovanij. Fundamental'nye issledovanija. 2013; 9 (2): 239–42. [Zaytseva M.A., Ivanov M.B., Pikalova L.V., Kashina T.V. Objectives and quality policy when carrying out preclinical studies. Fundamental'nie issledovaniya. 2013; 9 (2): 239–42 (in Russian)]
  8. Engalycheva G.N., Sjubaev R.D., Gorjachev D.V. Standarty kachestva doklinicheskih farmakologicheskih issledovanij. Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primenenija. 2019; 9 (4): 248–55. DOI: 10.30895/1991-2919-2019-9-4-248-255 [Engalycheva G.N., Syubaev R.D., Goryachev D.V. Quality Standards of Preclinical Pharmacological Studies. Vedomosti Nauchnogo tsentra ekspertizi sredstv meditsinskogo primeneniya. 2019; 9 (4): 248–55. DOI: 10.30895/1991-2919-2019-9-4-248-255 (in Russian)]
  9. Fikes J.D., Patrick D.J., Francke S. et al. Socity of Toxicologic Pathology Scientific and Regulatory Policy Committee Review: Review of the Organisation for Economic Co-operation and Development (OECD) Guidance on the GLP Requirements for Peer Review of Histopathology. Toxicol. Pathol. 2015; 43 (7): 907–14. DOI: 10.1177/0192623315596382
  10. Gyger M., Berdoy M., Dontas .I. et al. FELASA accreditation of education and training courses in laboratory animal science according to the Directive 2010/63/EU. Lab. Anim. 2019; 53 (2): 137–47. DOI: 10.1177/0023677218788105
  11. Itogi gosudarstvennogo kontrolja kachestva lekarstvennyh sredstv, kontrolja kachestva provedenie doklinicheskih issledovanij lekarstvennyh sredstv i klinicheskih issledovanij lekarstvennyh preparatov, monitoringa bezopasnosti lekarstvennyh preparatov i meditsinskih izdelij za 2014 god. [Elektronnoe izdanie]. Rezhim dostupa: https://roszdravnadzor.gov.ru/i/upload/images/2015/4/6/1428320549.08744-1-27554 (data obraschenija 1.12.2020). [Results of the state quality control of medicines, quality control conducting preclinical studies of medicines and clinical studies of medicines, monitoring the safety of medicines and medical devices for 2014. [Electronic resource]. Access mode: https://roszdravnadzor.gov.ru/i/upload/images/2015/4/6/1428320549.08744-1-27554 (circulation date 1.12.2020). (in Russian)]
  12. Bioresearch Monitoring (BIMO) Fiscal Year 2019. [Electronic resource]. Access mode: https://www.fda.gov/media/136797/download (circulation date 1.12.2020)