The rules of good laboratory practice
Abstract
With the aim to harmonize the legislation between the Eurasian Economic Union countries and the European Union in the field of medicines circulation and taking into account the requirements of the European Union and the Organization for Economic Cooperation and Development (OECD) in 2015 were developed the Rules of Good Laboratory Practice EAEC. The article presents the results of a comparative analysis of good laboratory practice. Order of the Ministry of Health of the Russian Federation on the Rules of good laboratory practice will allow to provide the most objective study of the safety of new drugs at the preclinical stage and to identify and prevent using of unsafe drugs. Ultimately, it will protect the interests of patients and the healthcare system as a whole.
Keywords
правила надлежащей лабораторной практики,
Евразийский экономический союз,
Российская Федерация,
Европейский Союз,
Организация экономического сотрудничества и развития,
The rules of good laboratory practice,
the Eurasian economic Union,
the Russian Federation,
the European Union,
the Organization for economic cooperation and development
About the Authors
N. Yu. Velts
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
R. N. Alyautdin
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
A. S. Kazakov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
T. M. Bukatina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
M. A. Darmostukova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
References
1. Guideline on Good laboratory practicies (GLP). Avaiable at URL: http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/konsultComitet/Documents/GLP%20%D0%B2%D0%B5%D1%80%D1%81%D0%B8%D1%8F%203.pdf (Cited: 22.12.2015).
2. Handbook: good laboratory practice (GLP): quality practices for regulated non- clinical research and development — 2nd ed. World Health Organization [ñàéò]. URL: http://www.who.int/tdr/publications/documents/glp-handbook.pdf. (äàòà îáðàùåíèÿ: 22.12.2015).
3. OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring [ñàéò]. URL: http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypra cticeglpandcomplian cemonitoring.htm. (äàòà îáðàùåíèÿ — 22.12.2015).
4. Merkulov VA, Bunjatjan ND, Sakaeva IV, Lepakhin VK, Romanov BK, Efremova TA. New legislation initiatives to improve drug safety in European Union. Scientific centre of expert evaluation of medicinal product bulletin. 2013; 3: 45–48.
5. Bezopasnost lekarstvennih sredstv. Merkulov VA, Bunjatjan ND, Lepakhin VK, Romanov BK. V sbornike: Osnovnie aspekti razvitija megapolisov I pharmakologicheskih klasterov, podgotovki k usovershenstvovaniju specialistov pharmacevticheskogo profilja. Materriali Conferencii, v ramkah XX-go Rossijskogo nacionalnogo Congressa «Chelovek I lekarstvo ». Moskwa, 2013. S. 13–16.
6. Romanov BK. New legislation in the area of drug safety in Russian Federation (Editorial). Safety and risk of pharmacotherapy. 2015; 2: 4.
7. Guideline on Good laboratory practicies (GLP). URL: http://regulation.gov.ru/projectsnpa=28088 (Cited: 22.12.2015).
8.
Review
For citations:
Velts N.Yu., Alyautdin R.N., Kazakov A.S., Bukatina T.M., Darmostukova M.A. The rules of good laboratory practice. Safety and Risk of Pharmacotherapy. 2016;(1):28-32. (In Russ.)
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