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OF THE EUROPEAN PARLIAMENT

AND OF THE COUNCIL

http://eur-lex.europa.eu/en/repert/1530.htm

 

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 

 

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 

 

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

http://eur-lex.europa.eu/JOYear.do?year=2003 

 

ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT (OECD)

www.oecd.org/ehs/

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

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)

http://www.ema.europa.eu 

GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE London, 20 January 2010 

Doc. Ref.: CPMP/EWP/QWP/1401/98 Rev. 1/ Corr **
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)

http://www.ema.europa.eu/.../Scientific_guideline/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
(CHMP/EWP/40326/06).
This guideline includes recommendations on BCS-based biowaivers.

Guideline on bioanalytical  method validation.- EMEA/CHMP/EWP/192217/2009, EMA, 2011

 

http://www.ema.europa.eu/.../Scientific_guideline/2011/08/WC500109686.pdf

 

Good Clinical Practice compliance

 http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/ 

 

EMA procedural advice for users of the centralised procedure for generic/hybrid applications

January 2011
Doc. Ref. EMEA/CHMP/225411/2006
http://www.ema.europa.eu/.../2009/10/WC500004018.pdf

 

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)

Guidance for Industry

“Bioanalytical Method Validation”  May, 2001

http://www.fda.gov/cvm

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)

 

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

 

http://www.fda.gov/downloads/.../ucm052363.pdf

 

WORLD HEALTH ORGANIZATION (WHO)

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

 

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

 

 

 

REGULATORY DOCUMENTS OF UKRAINE

http://zakon.rada.gov.ua 

http://zakon1.rada.gov.ua/cgi-bin/laws/main.cgi?nreg=123/96-вр 

http://www.moz.gov.ua/ua/portal/ 

http://www.dec.gov.ua/

http://www.diklz.gov.ua/

http://www.sphu.org/