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110 documents on 3 pages

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Quality and Safety: Medicines

Quality Assurance

Title:	13th International Conference of Drug Regulatory Authorities (ICDRA) Berne, Switzerland, 16-19 September 2008. ICDRA: Medicines Agencies Decide Future Action
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Year:	2008 Pages: 19
Publishers:	WHO Headquarters in Geneva
Related links:	http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/en/index.html
Regions:	Global

Title:	14th International Conference of Drug Regulatory Authorities(ICDRA), Singapore 30 November - 3 December 2010
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Year:	2011 Pages: 16
Publishers:	WHO Headquarters in Geneva
Related links:	http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/en/index.html

Title:	Accelerated Stability Studies of Widely Used Pharmaceutical Substances Under Simulated Tropical Conditions
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	1986 Pages: 119
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Additional Guidance for Organizations Performing in Vivo Bioequivalence Studies. WHO Technical Report Series, No. 937, 2006, Annex 9
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2006 Pages: 23
Publishers:	WHO Headquarters in Geneva
Related documents:	WHO Expert Committee on Selection and Use of Essential Medicines - WHO Technical Report Series, No. 850, Annex 3 (Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products) - Sixth Report Proposal to Waive in Vivo Bioequivalence Requirements for WHO Model List of Essential Medicines Immediate-release, Solid Oral Dosage Forms. WHO Technical Report Series, No. 937, 2006, Annex 8
Regions:	Global

Title:	Antimalarial Medicines in Kenya. Availability, Quality and Registration Status. A Baseline Study Undertaken Prior to Nationwide Distribution of Artemether-Lumefantine (AL) in Kenya
Subjects:	Medicine Information and Evidence for Policy > Medicines Policy Quality and Safety: Medicines > Quality Assurance
Year:	2007 Pages: 41
Publishers:	WHO Country Office in Kenya Kenya Ministry of Health Health Action International - Africa
Regions:	EAC East African Community
Countries:	Kenya

Title:	Application of Hazard Analysis and Critical Control Point (HACCP) Methodology to Pharmaceuticals. WHO Technical Report Series, No. 908, 2003, Annex 7
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Year:	2003 Pages: 14
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Basic Tests for Drugs - Pharmaceutical Substances, Medicinal Plant Materials and Dosage Forms [French] [Spanish]
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	1998 Pages: 100
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Basic Tests for Pharmaceutical Substances [French] [Spanish]
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	1986 Pages: 216
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Considerations for Requesting Analysis of Drug Samples. WHO Technical Report Series, No. 902, 2002, Annex 4
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2002 Pages: 4
Publishers:	WHO Headquarters in Geneva
Related documents:	Model Certificate of Analysis. WHO Technical Report Series, No. 902, 2002, Annex 10
Regions:	Global

Title:	Development of Paediatric Medicines: Points to Consider in Formulation. WHO Technical Report Series, No. 970, 2012, Annex 5
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2012 Pages: 29
Publishers:	WHO Headquarters in Geneva
Related documents:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 970 - Forty-sixth Report (Geneva, 10–14 October 2011)
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/guidelines/en/index.html http://www.who.int/childmedicines/en/
Regions:	Global

Title:	Drug Quality Control Laboratories
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	1999 Pages: 42
Publishers:	World Health Organization - Regional Office for Africa (WHO/AFRO)
Related documents:	Report of a Meeting on the Optimal Use of Regional Drug Quality Control Laboratories in Africa
Regions:	Africa (AFRO)

Title:	Drug Quality Screening in Developing Countries: Establishment of an Appropriate Laboratory in Swaziland
Subjects:	Quality and Safety: Medicines > Quality Assurance
Author:	Kenyon, A.S.; Kenyon, T.A.; Sibiya, T.
Year:	1994 Pages: 6
Publishers:	WHO Headquarters in Geneva
Countries:	Swaziland

Title:	EDM Research Series [French] [Spanish]
Subjects:	Medicine Access and Rational Use > Financing Medicine Access and Rational Use > Rational Use Quality and Safety: Medicines > Quality Assurance
Publishers:	WHO Headquarters in Geneva

Title:	Ensuring Quality Medicines: A Decade of Prequalification
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Author:	van Zyl, A. J.
Year:	2011 Pages: 9
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Framework for Implementation of Equivalence Requirements for Pharmaceutical Products. PANDRH Technical Report Nº 8, Pan American Network on Drug Regulatory Harmonization
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2011 Pages: 38
Publishers:	World Health Organization - Regional Office for the Americas (WHO/AMRO/PAHO)
Regions:	Global; America (AMRO)

Title:	Good Manufacturing Practices for Biological Products. In: WHO Expert Committee on Biological Standardization. Forty-second Report. Geneva, World Health Organization, 1992 (WHO Technical Report Series, No. 822), Annex 1; and WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second Report. Geneva, World Health Organization, 1993 (WHO Technical Report Series, No. 834), Annex 3
Subjects:	Quality and Safety: Medicines > Blood Products and Related Biologicals Quality and Safety: Medicines > Quality Assurance
Year:	1992 Pages: 11
Publishers:	WHO Headquarters in Geneva
Related documents:	WHO Expert Committee on Biological Standardization - WHO Technical Report Series, No. 822 - Forty-second Report WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Regions:	Global

Title:	Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Investigational Pharmaceutical Products for Clinical Trials in Humans. WHO Technical Report, Series No. 863 , 1996, Annex 7
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	1996 Pages: 16
Publishers:	WHO Headquarters in Geneva
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Regions:	Global

Title:	Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Pharmaceutical Excipients. WHO Technical Report Series, No. 885, 1999, Annex 5
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	1999 Pages: 22
Publishers:	WHO Headquarters in Geneva
Related documents:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Regions:	Global

Title:	Good Practices for Selecting and Procuring Rapid Diagnostic Tests for Malaria
Subjects:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Quality Assurance
Year:	2011 Pages: 109
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Good Procurement Practices for Artemisinin-Based Antimalarial Medicines
Subjects:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Quality Assurance
Year:	2010 Pages: 128
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Good Trade and Distribution Practices for Pharmaceutical Starting Materials. WHO Technical Report Series, No. 917, 2003, Annex 2
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2003 Pages: 19
Publishers:	WHO Headquarters in Geneva
Related documents:	WHO Pharmaceutical Starting Materials Certification Scheme (SMACS): Guidelines on Implementation. WHO Technical Report Series, No. 917, 2003, Annex 3
Regions:	Global

Title:	Guidance for Inspection of Drug Distribution Channels. WHO Technical Report Series, No. 885, 1999, Annex 6
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Year:	1999 Pages: 21
Publishers:	WHO Headquarters in Geneva
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/inspections/en/index.html
Regions:	Global

Title:	Guidance on Good Manufacturing Practices (GMP): Inspection Report. WHO Technical Report Series, No. 908, 2003, Annex 6
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2003 Pages: 5
Publishers:	WHO Headquarters in Geneva
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/inspections/en/index.html
Regions:	Global

Title:	Guidance on the Selection of Comparator Pharmaceutical Products for Equivalence Assessment of Interchangeable Multisource (Generic) Products. WHO Technical Report Series, No. 902, 2002, Annex 11
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Year:	2002 Pages: 20
Publishers:	WHO Headquarters in Geneva
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/en/index.html
Regions:	Global

Title:	Guidance on Variations to a Prequalified Product Dossier. WHO Technical Report Series, No. 943, 2007 Annex 6
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2007 Pages: 50
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Guide to Good Storage Practices for Pharmaceuticals. WHO Technical Report Series, No. 908, 2003, Annex 9
Subjects:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Quality Assurance
Year:	2003 Pages: 12
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Guidelines for Registration of Fixed-dose Combination Medicinal Products. WHO Technical Report Series, No. 929, 2005, Annex 5
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2005 Pages: 49
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Guidelines for the Preparation of a Procurement Agency Information File. WHO Technical Report Series, No. 917, 2003, Annex 7
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2003 Pages: 4
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Guidelines on Active Pharmaceutical Ingredient Master File Procedure. WHO Technical Report Series, No. 948, 2008, Annex 4
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2008 Pages: 10
Publishers:	WHO Headquarters in Geneva
Related documents:	Guidelines on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product for the WHO Prequalification of Medicines Programme: Quality Part. WHO Technical Report Series, No. 970, 2012, Annex 4
Regions:	Global

Title:	Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). WHO Expert Committee on Biological Standardization, 19-23 October 2009 [Portuguese] [Spanish]
Subjects:	Quality and Safety: Medicines > Blood Products and Related Biologicals Quality and Safety: Medicines > Quality Assurance
Year:	2009 Pages: 34
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Guidelines on Good Manufacturing Practices for Radiopharmaceutical Products. WHO Technical Report Series, No. 908, 2003, Annex 3
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2003 Pages: 10
Publishers:	WHO Headquarters in Geneva
Related documents:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 908 - Thirty-seventh Report
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Regions:	Global

Title:	Guidelines on Packaging for Pharmaceutical Products. WHO Technical Report Series, No. 902, 2002, Annex 9
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2002 Pages: 38
Publishers:	WHO Headquarters in Geneva
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/en/index.html
Regions:	Global

Title:	Guidelines on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product for the WHO Prequalification of Medicines Programme: Quality Part. WHO Technical Report Series, No. 970, 2012, Annex 4
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2012 Pages: 76
Publishers:	WHO Headquarters in Geneva
Related documents:	Pharmaceutical Development of Multisource (Generic) Finished Pharmaceutical Products – Points to Consider. WHO Technical Report Series, No. 970, 2012, Annex 3 Guidelines on Submission of Documentation for a Multisource (Generic) Finished Product. General Format: Preparation of Product Dossiers in Common Technical Document Format. WHO Technical Report Series, No. 961, 2011, Annex 15 Guidelines on Submission of Documentation for Prequalification of Innovator Finished Pharmaceutical Products Approved by Stringent Regulatory Authorities. WHO Technical Report Series, No. 961, 2011, Annex 11 Guidelines on Active Pharmaceutical Ingredient Master File Procedure. WHO Technical Report Series, No. 948, 2008, Annex 4
Regions:	Global

Title:	Guidelines on Submission of Documentation for a Multisource (Generic) Finished Product. General Format: Preparation of Product Dossiers in Common Technical Document Format. WHO Technical Report Series, No. 961, 2011, Annex 15
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2011 Pages: 12
Publishers:	WHO Headquarters in Geneva
Related documents:	Guidelines on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product for the WHO Prequalification of Medicines Programme: Quality Part. WHO Technical Report Series, No. 970, 2012, Annex 4 Guidelines on Submission of Documentation for Prequalification of Innovator Finished Pharmaceutical Products Approved by Stringent Regulatory Authorities. WHO Technical Report Series, No. 961, 2011, Annex 11
Regions:	Global

Title:	Guidelines on Submission of Documentation for Prequalification of Innovator Finished Pharmaceutical Products Approved by Stringent Regulatory Authorities. WHO Technical Report Series, No. 961, 2011, Annex 11
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2011 Pages: 2
Publishers:	WHO Headquarters in Geneva
Related documents:	Guidelines on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product for the WHO Prequalification of Medicines Programme: Quality Part. WHO Technical Report Series, No. 970, 2012, Annex 4 Guidelines on Submission of Documentation for a Multisource (Generic) Finished Product. General Format: Preparation of Product Dossiers in Common Technical Document Format. WHO Technical Report Series, No. 961, 2011, Annex 15
Regions:	Global

Title:	Guiding Principles to Ensure Injection Device Security
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Safety and Efficacy
Year:	2003 Pages: 2
Publishers:	WHO Headquarters in Geneva

Title:	Handbook: Good Laboratory Practice (GLP). Quality Practices for Regulated Non-clinical Research and Development - 2nd Ed.
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2009 Pages: 328
Publishers:	WHO/TDR - World Health Organization Special Programme for Research and Training in Tropical Diseases WHO Headquarters in Geneva The World Bank (WB) United Nations Children's Fund (UNICEF) United Nations Development Programme (UNDP)
Related documents:	Handbook: Non-Clinical Safety Testing
Regions:	Global

Title:	Improving Quality for Better Treatment and Greater Access
Subjects:	Medicine Access and Rational Use > Pricing Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2012 Pages: 7
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Inspection of API Manufacturing Sites
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2011 Pages: 4
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Joint FIP/WHO Guidelines on Good Pharmacy Practice: Standards for Quality of Pharmacy Services. WHO Technical Report Series, No. 961, 2011, Annex 8
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Safety and Efficacy
Year:	2011 Pages: 14
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Malaria Microscopy Quality Assurance Manual. Version 1
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2009 Pages: 149
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Mechanism to Combat Substandard/Spurious/Falsely-labelled/ Falsified/Counterfeit Medical Products (WHO Drug Information, Vol 27, No. 1, 2013)
Subjects:	Medicine Information and Evidence for Policy > Information and Publications Quality and Safety: Medicines > Counterfeit Medicines Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2013 Pages: 2
Publishers:	WHO Headquarters in Geneva
Related documents:	WHO Drug Information Vol. 27, No. 1, 2013 - Recommended International Nonproprietary Names, List 69
Regions:	Global; Africa (AFRO)

Title:	Model Certificate of Analysis. WHO Technical Report Series, No. 902, 2002, Annex 10
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2002 Pages: 4
Publishers:	WHO Headquarters in Geneva
Related documents:	Considerations for Requesting Analysis of Drug Samples. WHO Technical Report Series, No. 902, 2002, Annex 4
Regions:	Global

Title:	Model Certificate of Good Manufacturing Practices. WHO Technical Report Series, No. 908, 2003, Annex 5
Subjects:	Quality and Safety: Medicines > Quality Assurance
Year:	2003 Pages: 4
Publishers:	WHO Headquarters in Geneva
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/inspections/en/index.html
Regions:	Global

Title:	Model Guidance for the Storage and Transport of Time and Temperature-sensitive Pharmaceutical Products. WHO Technical Report Series, No.961, 2011, Annex 9
Subjects:	Quality and Safety: Medicines > Blood Products and Related Biologicals Quality and Safety: Medicines > Quality Assurance
Year:	2011 Pages: 49
Publishers:	WHO Headquarters in Geneva
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/distribution/en/index.html
Regions:	Global

Title:	A Model Quality Assurance System for Procurement Agencies - Recommendations for Quality Assurance Systems Focusing on Prequalification of Products and Manufacturers, Purchasing, Storage and Distribution of Pharmaceutical Products [French]
Subjects:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2007 Pages: 140
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability. WHO Technical Report Series, No. 937, 2006, Annex 7
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Year:	2006 Pages: 44
Publishers:	WHO Headquarters in Geneva
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/en/index.html
Regions:	Global

Title:	Pharmaceutical Development of Multisource (Generic) Finished Pharmaceutical Products – Points to Consider. WHO Technical Report Series, No. 970, 2012, Annex 3
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2012 Pages: 29
Publishers:	WHO Headquarters in Geneva
Related documents:	Guidelines on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product for the WHO Prequalification of Medicines Programme: Quality Part. WHO Technical Report Series, No. 970, 2012, Annex 4
Regions:	Global

Title:	Prequalification of Quality Control Laboratories. Procedure for Assessing the Acceptability, in Principle, of Quality Control Laboratories for Use by United Nations Agencies. WHO Technical Report Series, No. 961, 2011, Annex 12 [French]
Subjects:	Quality and Safety: Medicines > Quality Assurance Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2011 Pages: 10
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Procedure for Assessing the Acceptability, in Principle, of Procurement Agencies for Use by United Nations Agencies. WHO Technical Report Series, No. 917, 2003, Annex 6
Subjects:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Quality Assurance
Year:	2003 Pages: 10
Publishers:	WHO Headquarters in Geneva
Related documents:	WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 917 - Thirty-eighth Report
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/distribution/en/index.html
Regions:	Global


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Last updated: May 3, 2013