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62 documents on 2 pages

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Quality and Safety: Medicines

Regulatory Support

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:	15th International Conference of Drug Regulatory Authorities (ICDRA), Tallinn, Estonia, 23–26 October 2012
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2012 Pages: 23
Publishers:	WHO Headquarters in Geneva
Related links:	http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/en/index.html
Regions:	Global

Title:	African Medicines Registration Harmonisation (AMRH) Initiative: Summary, Status and Future Plans. The New Partnership for Africa’s Development (NEPAD) & the World Health Organization (WHO)
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2009 Pages: 13
Publishers:	WHO Headquarters in Geneva NEPAD - The New Partnership for Africa's Development / African Union (AU)
Related links:	http://www.afro.who.int/en/clusters-a-programmes/hss/essential-medicines/edm-publications.html
Regions:	Africa (AFRO)

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:	Assessment of Medicines Regulatory Systems in Sub-Saharan African Countries. An Overview of Findings from 26 Assessment Reports
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2010 Pages: 48
Publishers:	WHO Headquarters in Geneva
Regions:	Africa (AFRO)

Title:	Effective Drug Regulation - A Multicountry Study and Annex 1: Guide for Data Collection to Assess Drug Regulatory Performance
Subjects:	Quality and Safety: Medicines > Regulatory Support
Author:	Ratanawijitrasin, Sauwakon; Wondemagegnehu, Eshetu
Year:	2002 Pages: 187
Publishers:	WHO Headquarters in Geneva

Title:	Effective Medicines Regulation: Ensuring Safety, Efficacy and Quality - WHO Policy Perspectives on Medicines, No. 007, November 2003 [French] [Spanish]
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2003 Pages: 6
Publishers:	WHO Headquarters in Geneva

Title:	Essential Drugs and Registration of Pharmaceuticals: The Sri Lankan Experience
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	1993 Pages: 7
Publishers:	WHO Headquarters in Geneva
Countries:	Sri Lanka

Title:	Establishment of Statutory Drug Regulation in Developing Countries
Subjects:	Quality and Safety: Medicines > Regulatory Support
Author:	Fallet, Patrick
Year:	1983 Pages: 10
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	First African Medicines Regulatory Authorities Conference - Final Report. Addis Ababa, Ethiopia, 31 October – 3 November 2005
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2009 Pages: 50
Publishers:	World Health Organization - Regional Office for Africa (WHO/AFRO)
Regions:	Africa (AFRO)

Title:	Good Pharmacovigilance Practices for the Americas. PANDRH Technical Document Nº 5, Pan American Network on Drug Regulatory Harmonization [Portuguese] [Spanish]
Subjects:	Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy
Year:	2011 Pages: 83
Publishers:	World Health Organization - Regional Office for the Americas (WHO/AMRO/PAHO)
Regions:	America (AMRO)

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 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:	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 Registration of Traditional Medicines in the WHO African Region
Subjects:	Traditional Medicine > Traditional, Complementary and Herbal Medicine Quality and Safety: Medicines > Regulatory Support
Year:	2010 Pages: 40
Publishers:	World Health Organization - Regional Office for Africa (WHO/AFRO)
Related links:	http://www.afro.who.int/en/clusters-a-programmes/hss/essential-medicines.html
Regions:	Africa (AFRO)

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 for the Regulatory Assessment of Medicinal Products for Use in Self-Medication
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2000 Pages: 31
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	How to Implement Computer-Assisted Drug Registration - A Practical Guide for Drug Regulatory Authorities - Regulatory Support Series No. 002
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	1998 Pages: 74
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	II Workshop on Medicines Regulation in the Caribbean. Strengthening of National Medicines Regulation Authorities. Barbados, 08-09 September 2009
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2009 Pages: 42
Publishers:	World Health Organization - Regional Office for the Americas (WHO/AMRO/PAHO)
Related documents:	Regulation of Pharmaceuticals in the Caribbean Countries. Barbados, September 2006
Regions:	America (AMRO)

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:	International Conference of Drug Regulatory Authorities
Subjects:	Quality and Safety: Medicines > Regulatory Support
Publishers:	WHO Headquarters in Geneva

Title:	List of Globally Identified Websites of Medicines Regulatory Authorities. (As of November, 2009)
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2009 Pages: 7
Publishers:	WHO Headquarters in Geneva
Related links:	http://www.who.int/medicines/areas/quality_safety/regulation_legislation/en/index.html
Regions:	Global

Title:	Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products: A Manual for National Medicines Regulatory Authorities (NMRAs) – 2nd Edition
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2011 Pages: 148
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Medicines Regulatory Authorities: Current Status and the Way Forward. Regional Committee for Africa, Fifty-sixth Session. Addis Ababa, Ethiopia, 28 August–1 September 2006 [French]
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2006 Pages: 6
Publishers:	World Health Organization - Regional Office for Africa (WHO/AFRO)
Related links:	http://www.afro.who.int/
Regions:	Africa (AFRO)

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:	Optimization of Medicines Regulatory Authority Web Sites. Review of Web Sites: 2001 and 2009
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2010 Pages: 7
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Pharmaceuticals and the Internet Drug Regulatory Authorities' Perspective - Joint NLN-WHI Workshop, 24-25 September 2001
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2002 Pages: 80
Publishers:	WHO Headquarters in Geneva
Regions:	Global; Africa (AFRO)
Countries:	Bulgaria; Denmark; Estonia; Netherlands; Sweden

Title:	Pharmaceuticals: Restrictions in Use and Availability. Update of the Fourteenth Issue. (Prepared within the Context of the United Nations Publication, "Consolidated List of Products whose Consumption and/or Sale have been Banned, Withdrawn, Severely Restricted or Not Approved by Governments")
Subjects:	Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy
Year:	2010 Pages: 61
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Practical Guidance for Conducting a Review. Regulatory Support Series, No.12 (Based on the WHO Data Collection Tool for the Review of Drug Regulatory Systems)
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2007 Pages: 94
Publishers:	WHO Headquarters in Geneva
Related documents:	WHO Data Collection Tool for the Review of Drug Regulatory Systems. Regulatory Support Series, No.11. (To Be Used Jointly with the Practical Guidance for Conducting a Review) Assessment of Medicines Regulatory Systems in Sub-Saharan African Countries. An Overview of Findings from 26 Assessment Reports
Regions:	Global

Title:	Provisional Guidelines on the Inspection of Pharmaceutical Manufacturers. WHO Technical Report Series 823, 1992, Annex 2
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Year:	1992 Pages: 12
Publishers:	WHO Headquarters in Geneva
Related links:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/inspections/en/index.html
Regions:	Global

Title:	Regulating Pharmaceuticals in Europe: Striving for Efficiency, Equity and Quality [Russian]
Subjects:	Medicine Information and Evidence for Policy > Medicines Policy Medicine Access and Rational Use > Financing Medicine Access and Rational Use > Pricing Quality and Safety: Medicines > Regulatory Support
Author:	Mossialos, E. A.; Mrazek, M.; Walley, T
Year:	2004 Pages: 395
Publishers:	World Health Organization - Regional Office for Europe (WHO/EURO) European Observatory on Health Systems and Policies
Related links:	http://www.euro.who.int/en/what-we-publish/sections/search/a-z-list-of-all-publications
Regions:	Europe (EURO)

Title:	Regulation of Pharmaceuticals in Developing Countries. Legal Issues and Approaches
Subjects:	Quality and Safety: Medicines > Regulatory Support
Author:	Jayasuriya, D.C.
Year:	1985 Pages: 118
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Regulation of Pharmaceuticals in the Caribbean Countries. Barbados, September 2006
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2006 Pages: 34
Publishers:	World Health Organization - Regional Office for the Americas (WHO/AMRO/PAHO)
Related documents:	II Workshop on Medicines Regulation in the Caribbean. Strengthening of National Medicines Regulation Authorities. Barbados, 08-09 September 2009
Regions:	America (AMRO)

Title:	Regulatory Situation of Herbal Medicines - A Worldwide Review [French] [Spanish]
Subjects:	Traditional Medicine > Traditional, Complementary and Herbal Medicine Quality and Safety: Medicines > Regulatory Support
Year:	1998 Pages: 49
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Regulatory Support Series [French]
Subjects:	Quality and Safety: Medicines > Regulatory Support
Publishers:	WHO Headquarters in Geneva

Title:	Report of a Consultation on Basic Elements of Drug Legislation and Regulatory Control for Developing Countries [French]
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	1981 Pages: 34
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Report of the Situation of Counterfeit Medicines Based on Data Collection Tool. WHO Regions for Africa and Eastern Mediterranean
Subjects:	Quality and Safety: Medicines > Counterfeit Medicines Quality and Safety: Medicines > Regulatory Support
Year:	2010 Pages: 27
Publishers:	WHO Headquarters in Geneva
Regions:	Africa (AFRO); Eastern Mediterranean (EMRO)

Title:	The Role of Ethics in the Rational Use of Medicines. SEARO Technical Publication Series No. 46
Subjects:	Medicine Access and Rational Use > Rational Use Medicine Programme Coordination > Human Resources for Pharmaceutical Sector Quality and Safety: Medicines > Regulatory Support
Year:	2007 Pages: 74
Publishers:	World Health Organization - Regional Office for South-East Asia (WHO/SEARO)
Related links:	http://www.searo.who.int/entity/medicines/documents/en/
Regions:	Global; South-East Asia (SEARO)

Title:	A Situational Analysis and Feasibility Study on Regional Pooled Bulk Procurement of Essential Medicines and Other Health Supplies in the East African Community Partner States. Final report, September 2007
Subjects:	Medicine Access and Rational Use > Financing Medicine Access and Rational Use > Pricing Medicine Access and Rational Use > Supply Management Medicine Programme Coordination > Programme Coordination Quality and Safety: Medicines > Regulatory Support
Year:	2007 Pages: 110
Publishers:	WHO Headquarters in Geneva John Snow Inc. (JSI) Management Sciences for Health (MSH) - Rational Pharmaceutical Management Plus
Regions:	Africa (AFRO); EAC East African Community

Title:	Theme Paper for Discussion - Effective Drug Regulation: What Can Countries Do?, Geneva, 16-19 March 1999 [French]
Subjects:	Medicine Information and Evidence for Policy > Medicines Policy Quality and Safety: Medicines > Regulatory Support
Author:	Wondemagegnehu, Eshetu
Year:	1999 Pages: 53
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Data Collection Tool for the Review of Drug Regulatory Systems. Regulatory Support Series, No.11. (To Be Used Jointly with the Practical Guidance for Conducting a Review) [Russian]
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2007 Pages: 71
Publishers:	WHO Headquarters in Geneva
Related documents:	Assessment of Medicines Regulatory Systems in Sub-Saharan African Countries. An Overview of Findings from 26 Assessment Reports Practical Guidance for Conducting a Review. Regulatory Support Series, No.12 (Based on the WHO Data Collection Tool for the Review of Drug Regulatory Systems)
Regions:	Global

Title:	WHO Drug Information Vol. 23, No. 3, 2009 - Recommended INN List 62 - International Nonproprietary Names for Pharmaceutical Substances
Subjects:	Medicine Information and Evidence for Policy > Information and Publications Quality and Safety: Medicines > International Nonproprietary Names Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2009 Pages: 78
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Drug Information Vol. 23, No. 4, 2009 - Proposed International Nonproprietary Names, List 102
Subjects:	Medicine Information and Evidence for Policy > Information and Publications Quality and Safety: Medicines > Blood Products and Related Biologicals Quality and Safety: Medicines > International Nonproprietary Names Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2009 Pages: 97
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Drug Information Vol. 24, No. 1, 2010 - Recommended International Nonproprietary Names, List 63
Subjects:	Medicine Information and Evidence for Policy > Information and Publications Quality and Safety: Medicines > International Nonproprietary Names Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2010 Pages: 80
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Drug Information Vol. 24, No. 2, 2010 - Proposed International Nonproprietary Names, List 103
Subjects:	Medicine Information and Evidence for Policy > Information and Publications Quality and Safety: Medicines > International Nonproprietary Names Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2010 Pages: 118
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Drug Information Vol. 24, No. 3, 2010 - Recommended International Nonproprietary Names, List 64
Subjects:	Medicine Information and Evidence for Policy > Information and Publications Quality and Safety: Medicines > International Nonproprietary Names Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy Quality and Safety: Medicines > The International Pharmacopoeia Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2010 Pages: 92
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Drug Information Vol. 24, No. 4, 2010 - Proposed International Nonproprietary Names, List 104
Subjects:	Medicine Information and Evidence for Policy > Information and Publications Quality and Safety: Medicines > International Nonproprietary Names Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2010 Pages: 128
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Drug Information Vol. 25, No. 1, 2011 - Recommended International Nonproprietary Names, List 65
Subjects:	Medicine Information and Evidence for Policy > Information and Publications Quality and Safety: Medicines > International Nonproprietary Names Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2011 Pages: 98
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	WHO Drug Information Vol. 25, No. 2, 2011 - Proposed International Nonproprietary Names, List 105
Subjects:	Medicine Information and Evidence for Policy > Information and Publications Quality and Safety: Medicines > International Nonproprietary Names Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy Quality and Safety: Medicines > The International Pharmacopoeia Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2011 Pages: 120
Publishers:	WHO Headquarters in Geneva
Regions:	Global


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Last updated: May 3, 2013