Ремедиум. 2018; : 6-11
GLP: объект становится субъектом. Проблемы признания GLP-статусов отечественных испытательных центров и исследований за рубежом
https://doi.org/10.21518/1561-5936-2018-5-6-11Аннотация
Список литературы
1. 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.
Remedium. 2018; : 6-11
Issues of recognition of GLP-status of domestic test facilities and trials abroad
https://doi.org/10.21518/1561-5936-2018-5-6-11Abstract
References
1. 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. Pravila nadlezhashchei laboratornoi praktiki Evraziiskogo ekonomicheskogo soyuza v sfere obrashcheniya lekarstvennykh sredstv. Utv. Resheniem Soveta Evraziiskoi ekonomicheskoi komissii ot 3 noyabrya 2016 goda №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. Vasil'ev A.N., Niyazov RR, Gavrishina E.V., Dranitsyna M.A., Kulichev D.A. Problemy planirovaniya i provedeniya doklinicheskikh issledovanii v Rossiiskoi Federatsii. Remedium, 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.
