National characteristics of preclinical studies and use of laboratory animals in Russia: problems and prospects
Abstract
The analysis of the international experience in conducting preclinical studies and application of the principle of good laboratory practice was made. The issues associated with the use of laboratory animals for scientific purposes in Russia and abroad were discussed. The prospects of improvement of legislative base of the Russian Federation in the field of preclinical studies with the application of the principle of good laboratory practice and use of laboratory animals for scientific purposes were identified.
About the Authors
A. N. Murashev
Shemyakin&Ovchinnikov Institute of Bioorganic Chemistry (Branch) RAS, Pushchino State Natural-Science Institute
Russian Federation
Russian Federation
V. S. Popov
Lomonosov Moscow State University
Russian Federation
Russian Federation
M. S. Krasilshchikova
Shemyakin & Ovchinnikov Institute of Bioorganic Chemistry RAS
Russian Federation
Russian Federation
T. Yu. Zharmukhamedova
Shemyakin&Ovchinnikov Institute of Bioorganic Chemistry (Branch) RAS, Pushchino State Natural-Science Institute
Russian Federation
Russian Federation
D. I. Rzhevskiy
Shemyakin&Ovchinnikov Institute of Bioorganic Chemistry (Branch) RAS
Russian Federation
Russian Federation
O. N. Khokhlova
Shemyakin&Ovchinnikov Institute of Bioorganic Chemistry (Branch) RAS
Russian Federation
Russian Federation
References
1. Information letter of the Federal service for supervision in the sphere of health and social development dated 11.11.2009 № 04I-753/09.
2. The Federal law dated 12.04.2010 № 61-FZ «On circulation of medicines».
3. The order of the Ministry of health and social development of the Russian Federation dated 23.08.2010 № 708n «On approval of rules of laboratory practice».
4. GOST R 53434-2009 «Principles of good laboratory practice».
5. The RF Government decree dated 17.12.2013 № 1172 «On the recognition and on conformity assessment testing laboratories (centers) of the principles of good laboratory practice".
6. The order of the Government of the Russian Federation dated 28.12.2012, № 2603-R «On approval of the National program implementing the principles of good laboratory practice of the Organization for economic cooperation and development (OECD) in the activities of the Russian testing facilities (laboratories) in the field of non- clinical laboratory studies».
7. Federal law dated 22.12.2014 № 429-FZ «On amending the Federal law "On circulation of medicines».
8. The decree of the RF Government dated 8 November 2013 №2067-R «Approved the list of documents in the field of standardization, compliance with which is consistent with the principles of good laboratory practice OECD».
9. GOST 31881-2012 «The Role and responsibilities of the Director of studies in accordance with GLP Principles».
10. GOST 31882-2012 «The Organization and control of the archives».
11. GOST 31883-2012 «Quality Assurance in accordance with the Principles of GLP».
12. GOST 31884-2012 «Suppliers meet the test center to the Principles of GLP».
13. GOST 31887-2012 «The Application of GLP Principles to computerized systems».
14. GOST 31888-2012 «The Role and obligations of the sponsor in accordance with the Principles of GLP».
15. GOST 33044-2014 «Principles of good laboratory practice».
16. OF THE CRIMINAL CODE. Article 245 «Cruelty to animals».
17. European Convention for the protection of vertebrate animals used for experimental and other scientific purposes (ETS № 123).
18. Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010. Official Journal L 276, 20.10.2010: 33–79 (revising Directive 86/609/EEC).
19. GOST 33215-2014 «Rules equipment premises and organization procedures when working with laboratory animals».
20. GOST 33216-2014 «Rules of work with laboratory rodents and rabbits».
21. GOST 33217-2014 «Rules of work with laboratory predatory mammals».
22. GOST 33218-2014 «Rules for working with nonhuman primates».
23. GOST 33219-2014 «Rules of work with fish, amphibians, and reptiles».
Review
For citations:
Murashev A.N., Popov V.S., Krasilshchikova M.S., Zharmukhamedova T.Yu., Rzhevskiy D.I., Khokhlova O.N. National characteristics of preclinical studies and use of laboratory animals in Russia: problems and prospects. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2015;(2):35-39. (In Russ.)
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