REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot123610.21518/1561-5936-2018-5-6-11Original ArticleIssues of recognition of GLP-status of domestic test facilities and trials abroadNiyazovR. R.noemail@neicon.ruPozhidaevaD. N.noemail@neicon.ruGavrishinaE. V.noemail@neicon.ruDranitsynaM. A.noemail@neicon.ruKulichevD. Anoemail@neicon.ruCenter for Scientific Advice LLC05122018561118032022Copyright © 2018,2018For Russian pharmaceutical industry, the quality of non-clinical tests, which pursuant to internationally accepted requirements should be conducted in accordance with Good Laboratory Practice (GLP) standards, is of utmost importance. The best way to approximate problems in accepting the data generated by domestic test facilities is to directly refer to foreign competent authorities that both deal with foreign data and inspect foreign test facilities or audit foreign studies. In this paper, we highlight the general perception of the problem based on the communication with foreign government authorities responsible for enforcement of GLP rules.GLPnon-clinical studiesmedicinal producttoxicitytoxicologypharmacologymutual recognitionЛС1.MHRA Laboratories (GLP, GCP & GMPQC) Symposium. 27 February 2018 - The Queens Hotel, Leeds. URL: https://mhralabs.co.uk/ home (30.03.2018).2.Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances. Official Journal L 050, 20/02/2004 P 0044-0059.3.Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP). Official Journal L 050, 20/02/2004 P 0028-0043.4.The Good Laboratory Practice Regulations 1999. Statutory Instruments 1999 No. 3106. URL: http://www.legislation.gov.uk/ uksi/1999/3106/pdfs/uksi_19993106_en.pdf (30.03.2018).5.The Good Laboratory Practice (Codification Amendments Etc.) Regulations 2004. Statutory Instruments 2004 No. 994. URL: http:// www.legislation.gov.uk/uksi/2004/994/pdfs/uksi_20040994_en.pdf (30.03.2018).6.Правила надлежащей лабораторной практики Евразийского экономического союза в сфере обращения лекарственных средств. Утв. Решением Совета Евразийской экономической комиссии от 3 ноября 2016 года №81. URL http://docs.cntd.ru/docu-ment/456026101 (30.03.2018).7.Draft OECD GLP Advisory Document NO. 19 on the Management, Characterisation and Use of Test Items. Organisation for Economic Co-operation and Development. URL: http:// www.oecd.org/env/ehs/testing/4%20May%20 2017_Draft%20OECD%20Guidance%20 Doc%20on%20Test%20Items.pdf (30.03.2018).8.Васильев А.Н., Ниязов РР, Гавришина Е.В., Драницына М.А., Куличев Д.А. Проблемы планирования и проведения доклинических исследований в Российской Федерации. Ремедиум, 2017, 9. doi: http://dx.doi. org/10.21518/1561-5936-2017-9-6-18.9.Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC.