08200, Україна,
OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
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http://eur-lex.europa.eu/en/repert/1530.htm
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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
L 50/54-59 EN Official Journal of the European Union 20.2.2004 http://eur-lex.europa.eu/JOYear.do?year=2004
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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) L 50/28 EN Official Journal of the European Union 20.2.2004 http://eur-lex.europa.eu/JOYear.do?year=2004
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COMMISSION DIRECTIVE 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use L 262/22 EN Official Journal of the European Union 14.10.2003 |
ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT (OECD)
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OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring http://www.oecd.org/document/63/0,3746,en_2649_34365_2346175_1_1_1_1,00.html |
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ENV/MC/CHEM(98)17 Number 1 OECD Principles on Good Laboratory Practice (as revised in 1997) http://www.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/mc/chem(98)17&doclanguage=en |
THE EUROPEAN MEDICINES AGENCY FOR (EMA)
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GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE London, 20 January 2010 Doc. Ref.: CPMP/EWP/QWP/1401/98 Rev. 1/ Corr ** http://www.ema.europa.eu/.../2010/01/WC500070039.pdf This guideline will replace the “Note for guidance on the investigation of bioavailability and bioequivalence" CPMP/QWP/EWP/1401/98 and the related questions in the Q&A document |
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Guideline on bioanalytical method validation.- EMEA/CHMP/EWP/192217/2009, EMA, 2011
http://www.ema.europa.eu/.../2011/08/WC500109686.pdf
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Good Clinical Practice compliance http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/ |
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EMA procedural advice for users of the centralised procedure for generic/hybrid applications January 2011
Committee for Human Medicinal Products (CHMP) This integrated version has been created for printing purposes only. Please refer to the individual Question & Answers as published under ‘Pre-authorisation’, ‘Regulatory’ section on the Agency’s website for access to the hyperlinked information. |
FOOD AND DRUG ADMINISTRATION (FDA)
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Guidance for Industry “Bioanalytical Method Validation” May, 2001 http://www.fda.gov/cder/guidance/index.htm#Generics U.S. Department of Health and Human Services FDA; Center for Drug Evaluation and Research (CDER); Center for Veterinary Medicine (CVM)
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FDA «Guidance for Industry. Bioequivalence guidance» (2006). U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine (CVM) November 8, 2006
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WORLD HEALTH ORGANIZATION (WHO)
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Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products»)/WHO Expert Committee on Specifications for Pharmaceutical Preparations/ WHO Technical Report Series,№ 902, 2002 http://www.who.int/medicines/publications/pharmprep/TRS_902.pdf
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Regulatory guidance on interchangeability for multisource (generic) pharmaceutical products WHO Technical Report Series,№ 937, 2006 Geneva, 24–28 October 2005 http://www.who.int/medicines/publications/pharmprep/TRS_937.pdf Annex 8: Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms Annex 9 Additional guidance for organizations performing in vivo bioequivalence studies |
ЗАКОНОДАТЕЛЬСТВО УКРАИНЫ
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Закон Украины "Про лікарські засоби" http://zakon1.rada.gov.ua/cgi-bin/laws/main.cgi?nreg=123%2F96-%E2%F0
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Нормативные документы МЗ Украины, Государственного экспертного центра МЗ Украины (ГЭЦ), Госслужбы Украины по лекарственным средствам: http://www.moz.gov.ua/ua/portal/
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СТ-Н МОЗУ 42-7.0: 2008. «Руководства по клиническим исследованиям. Лекарственные средства. Надлежащая клиническая практика» Это руководство соответствует: CPMP/ICH/135/95 (E6) Note for Guidance on Good Clinical Practice, 2002 (Руководящие указания по надлежащей клинической практике, 2002) в части разделов 3 и 5, а также приложений А и Б.
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Руководство 42-7.1:2016 Лекарственные средства. Исследование биоэквивалентности Это руководство соответствует: CPMP/QWP/EWP/1401/98 Rev.1 Guideline on the Investigation of Bioequivalence, 2010, EMA/CHMP/600958/2010/Corr.* (17 November 2011): Appendix IX of Guideline on the Investigation of Bioequivalence. Presentation of Biopharmaceutical and Bioanalytical Data in Module 2.7.1.
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СТ-Н МОЗУ 42-6.0:2008 «Настанова. Лікарські засоби. Належна лабораторна практика» Это руководство соответствует документу: Good laboratory Practice OECD PRINCIPLES AND GUIDANCE FOR COMPLIANCE MONITORING |
