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Quality and Safety: Medicines

Regulatory Support

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Título:	13th International Conference of Drug Regulatory Authorities (ICDRA) Berne, Switzerland, 16-19 September 2008. ICDRA: Medicines Agencies Decide Future Action
Temas:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Año:	2008 Páginas: 19
Publicadores:	WHO Headquarters in Geneva
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/en/index.html
Regiones:	Global

Título:	14th International Conference of Drug Regulatory Authorities(ICDRA), Singapore 30 November - 3 December 2010
Temas:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Año:	2011 Páginas: 16
Publicadores:	WHO Headquarters in Geneva
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/en/index.html

Título:	15th International Conference of Drug Regulatory Authorities (ICDRA), Tallinn, Estonia, 23–26 October 2012
Temas:	Quality and Safety: Medicines > Regulatory Support
Año:	2012 Páginas: 23
Publicadores:	WHO Headquarters in Geneva
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/en/index.html
Regiones:	Global

Título:	African Medicines Registration Harmonisation (AMRH) Initiative: Summary, Status and Future Plans. The New Partnership for Africa’s Development (NEPAD) & the World Health Organization (WHO)
Temas:	Quality and Safety: Medicines > Regulatory Support
Año:	2009 Páginas: 13
Publicadores:	WHO Headquarters in Geneva NEPAD - The New Partnership for Africa's Development / African Union (AU)
Enlaces relacionados:	http://www.afro.who.int/en/clusters-a-programmes/hss/essential-medicines/edm-publications.html
Regiones:	África (AFRO)

Título:	Application of Hazard Analysis and Critical Control Point (HACCP) Methodology to Pharmaceuticals. WHO Technical Report Series, No. 908, 2003, Annex 7
Temas:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Año:	2003 Páginas: 14
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Assessment of Medicines Regulatory Systems in Sub-Saharan African Countries. An Overview of Findings from 26 Assessment Reports
Temas:	Quality and Safety: Medicines > Regulatory Support
Año:	2010 Páginas: 48
Publicadores:	WHO Headquarters in Geneva
Regiones:	África (AFRO)

Título:	Effective Drug Regulation - A Multicountry Study and Annex 1: Guide for Data Collection to Assess Drug Regulatory Performance
Temas:	Quality and Safety: Medicines > Regulatory Support
Autore:	Ratanawijitrasin, Sauwakon; Wondemagegnehu, Eshetu
Año:	2002 Páginas: 187
Publicadores:	WHO Headquarters in Geneva

Título:	Effective Medicines Regulation: Ensuring Safety, Efficacy and Quality - WHO Policy Perspectives on Medicines, No. 007, November 2003 [French] [Spanish]
Temas:	Quality and Safety: Medicines > Regulatory Support
Año:	2003 Páginas: 6
Publicadores:	WHO Headquarters in Geneva

Título:	Essential Drugs and Registration of Pharmaceuticals: The Sri Lankan Experience
Temas:	Quality and Safety: Medicines > Regulatory Support
Año:	1993 Páginas: 7
Publicadores:	WHO Headquarters in Geneva
Países:	Sri Lanka

Título:	Establishment of Statutory Drug Regulation in Developing Countries
Temas:	Quality and Safety: Medicines > Regulatory Support
Autore:	Fallet, Patrick
Año:	1983 Páginas: 10
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	First African Medicines Regulatory Authorities Conference - Final Report. Addis Ababa, Ethiopia, 31 October – 3 November 2005
Temas:	Quality and Safety: Medicines > Regulatory Support
Año:	2009 Páginas: 50
Publicadores:	World Health Organization - Regional Office for Africa (WHO/AFRO)
Regiones:	África (AFRO)

Título:	Good Pharmacovigilance Practices for the Americas. PANDRH Technical Document Nº 5, Pan American Network on Drug Regulatory Harmonization [Portuguese] [Spanish]
Temas:	Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy
Año:	2011 Páginas: 83
Publicadores:	World Health Organization - Regional Office for the Americas (WHO/AMRO/PAHO)
Regiones:	Américas (AMRO)

Título:	Guidance for Inspection of Drug Distribution Channels. WHO Technical Report Series, No. 885, 1999, Annex 6
Temas:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Año:	1999 Páginas: 21
Publicadores:	WHO Headquarters in Geneva
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/inspections/en/index.html
Regiones:	Global

Título:	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
Temas:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Año:	2002 Páginas: 20
Publicadores:	WHO Headquarters in Geneva
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/en/index.html
Regiones:	Global

Título:	Guidelines for Registration of Fixed-dose Combination Medicinal Products. WHO Technical Report Series, No. 929, 2005, Annex 5
Temas:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Prequalification of Medicines > WHO-UNICEF-UN Project
Año:	2005 Páginas: 49
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Guidelines for Registration of Traditional Medicines in the WHO African Region
Temas:	Traditional Medicine > Traditional, Complementary and Herbal Medicine Quality and Safety: Medicines > Regulatory Support
Año:	2010 Páginas: 40
Publicadores:	World Health Organization - Regional Office for Africa (WHO/AFRO)
Enlaces relacionados:	http://www.afro.who.int/en/clusters-a-programmes/hss/essential-medicines.html
Regiones:	África (AFRO)

Título:	Guidelines for the Preparation of a Procurement Agency Information File. WHO Technical Report Series, No. 917, 2003, Annex 7
Temas:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Prequalification of Medicines > WHO-UNICEF-UN Project
Año:	2003 Páginas: 4
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Guidelines for the Regulatory Assessment of Medicinal Products for Use in Self-Medication
Temas:	Quality and Safety: Medicines > Regulatory Support
Año:	2000 Páginas: 31
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	How to Implement Computer-Assisted Drug Registration - A Practical Guide for Drug Regulatory Authorities - Regulatory Support Series No. 002
Temas:	Quality and Safety: Medicines > Regulatory Support
Año:	1998 Páginas: 74
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	II Workshop on Medicines Regulation in the Caribbean. Strengthening of National Medicines Regulation Authorities. Barbados, 08-09 September 2009
Temas:	Quality and Safety: Medicines > Regulatory Support
Año:	2009 Páginas: 42
Publicadores:	World Health Organization - Regional Office for the Americas (WHO/AMRO/PAHO)
Documentos relacionados:	Regulation of Pharmaceuticals in the Caribbean Countries. Barbados, September 2006
Regiones:	Américas (AMRO)

Título:	Improving Quality for Better Treatment and Greater Access
Temas:	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
Año:	2012 Páginas: 7
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	International Conference of Drug Regulatory Authorities
Temas:	Quality and Safety: Medicines > Regulatory Support
Publicadores:	WHO Headquarters in Geneva

Título:	List of Globally Identified Websites of Medicines Regulatory Authorities. (As of November, 2009)
Temas:	Quality and Safety: Medicines > Regulatory Support
Año:	2009 Páginas: 7
Publicadores:	WHO Headquarters in Geneva
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/regulation_legislation/en/index.html
Regiones:	Global

Título:	Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products: A Manual for National Medicines Regulatory Authorities (NMRAs) – 2nd Edition
Temas:	Quality and Safety: Medicines > Regulatory Support
Año:	2011 Páginas: 148
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	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]
Temas:	Quality and Safety: Medicines > Regulatory Support
Año:	2006 Páginas: 6
Publicadores:	World Health Organization - Regional Office for Africa (WHO/AFRO)
Enlaces relacionados:	http://www.afro.who.int/
Regiones:	África (AFRO)

Título:	Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability. WHO Technical Report Series, No. 937, 2006, Annex 7
Temas:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Año:	2006 Páginas: 44
Publicadores:	WHO Headquarters in Geneva
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/en/index.html
Regiones:	Global

Título:	Optimization of Medicines Regulatory Authority Web Sites. Review of Web Sites: 2001 and 2009
Temas:	Quality and Safety: Medicines > Regulatory Support
Año:	2010 Páginas: 7
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Pharmaceuticals and the Internet Drug Regulatory Authorities' Perspective - Joint NLN-WHI Workshop, 24-25 September 2001
Temas:	Quality and Safety: Medicines > Regulatory Support
Año:	2002 Páginas: 80
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global; África (AFRO)
Países:	Bulgaria; Dinamarca; Estonia; Países Bajos; Suecia

Título:	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")
Temas:	Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy
Año:	2010 Páginas: 61
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	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)
Temas:	Quality and Safety: Medicines > Regulatory Support
Año:	2007 Páginas: 94
Publicadores:	WHO Headquarters in Geneva
Documentos relacionados:	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
Regiones:	Global

Título:	Provisional Guidelines on the Inspection of Pharmaceutical Manufacturers. WHO Technical Report Series 823, 1992, Annex 2
Temas:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Año:	1992 Páginas: 12
Publicadores:	WHO Headquarters in Geneva
Enlaces relacionados:	http://www.who.int/medicines/areas/quality_safety/quality_assurance/inspections/en/index.html
Regiones:	Global

Título:	Regulating Pharmaceuticals in Europe: Striving for Efficiency, Equity and Quality [Russian]
Temas:	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
Autore:	Mossialos, E. A.; Mrazek, M.; Walley, T
Año:	2004 Páginas: 395
Publicadores:	World Health Organization - Regional Office for Europe (WHO/EURO) European Observatory on Health Systems and Policies
Enlaces relacionados:	http://www.euro.who.int/en/what-we-publish/sections/search/a-z-list-of-all-publications
Regiones:	Europa (EURO)

Título:	Regulation of Pharmaceuticals in Developing Countries. Legal Issues and Approaches
Temas:	Quality and Safety: Medicines > Regulatory Support
Autore:	Jayasuriya, D.C.
Año:	1985 Páginas: 118
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Regulation of Pharmaceuticals in the Caribbean Countries. Barbados, September 2006
Temas:	Quality and Safety: Medicines > Regulatory Support
Año:	2006 Páginas: 34
Publicadores:	World Health Organization - Regional Office for the Americas (WHO/AMRO/PAHO)
Documentos relacionados:	II Workshop on Medicines Regulation in the Caribbean. Strengthening of National Medicines Regulation Authorities. Barbados, 08-09 September 2009
Regiones:	Américas (AMRO)

Título:	Regulatory Situation of Herbal Medicines - A Worldwide Review [French] [Spanish]
Temas:	Traditional Medicine > Traditional, Complementary and Herbal Medicine Quality and Safety: Medicines > Regulatory Support
Año:	1998 Páginas: 49
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Regulatory Support Series [French]
Temas:	Quality and Safety: Medicines > Regulatory Support
Publicadores:	WHO Headquarters in Geneva

Título:	Report of a Consultation on Basic Elements of Drug Legislation and Regulatory Control for Developing Countries [French]
Temas:	Quality and Safety: Medicines > Regulatory Support
Año:	1981 Páginas: 34
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	Report of the Situation of Counterfeit Medicines Based on Data Collection Tool. WHO Regions for Africa and Eastern Mediterranean
Temas:	Quality and Safety: Medicines > Counterfeit Medicines Quality and Safety: Medicines > Regulatory Support
Año:	2010 Páginas: 27
Publicadores:	WHO Headquarters in Geneva
Regiones:	África (AFRO); Mediterráneo Oriental (EMRO)

Título:	The Role of Ethics in the Rational Use of Medicines. SEARO Technical Publication Series No. 46
Temas:	Medicine Access and Rational Use > Rational Use Medicine Programme Coordination > Human Resources for Pharmaceutical Sector Quality and Safety: Medicines > Regulatory Support
Año:	2007 Páginas: 74
Publicadores:	World Health Organization - Regional Office for South-East Asia (WHO/SEARO)
Enlaces relacionados:	http://www.searo.who.int/entity/medicines/documents/en/
Regiones:	Global; Asia Sudoriental (SEARO)

Título:	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
Temas:	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
Año:	2007 Páginas: 110
Publicadores:	WHO Headquarters in Geneva John Snow Inc. (JSI) Management Sciences for Health (MSH) - Rational Pharmaceutical Management Plus
Regiones:	África (AFRO); EAC East African Community

Título:	Theme Paper for Discussion - Effective Drug Regulation: What Can Countries Do?, Geneva, 16-19 March 1999 [French]
Temas:	Medicine Information and Evidence for Policy > Medicines Policy Quality and Safety: Medicines > Regulatory Support
Autore:	Wondemagegnehu, Eshetu
Año:	1999 Páginas: 53
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	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]
Temas:	Quality and Safety: Medicines > Regulatory Support
Año:	2007 Páginas: 71
Publicadores:	WHO Headquarters in Geneva
Documentos relacionados:	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)
Regiones:	Global

Título:	WHO Drug Information Vol. 23, No. 3, 2009 - Recommended INN List 62 - International Nonproprietary Names for Pharmaceutical Substances
Temas:	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
Año:	2009 Páginas: 78
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	WHO Drug Information Vol. 23, No. 4, 2009 - Proposed International Nonproprietary Names, List 102
Temas:	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
Año:	2009 Páginas: 97
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	WHO Drug Information Vol. 24, No. 1, 2010 - Recommended International Nonproprietary Names, List 63
Temas:	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
Año:	2010 Páginas: 80
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	WHO Drug Information Vol. 24, No. 2, 2010 - Proposed International Nonproprietary Names, List 103
Temas:	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
Año:	2010 Páginas: 118
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	WHO Drug Information Vol. 24, No. 3, 2010 - Recommended International Nonproprietary Names, List 64
Temas:	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
Año:	2010 Páginas: 92
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	WHO Drug Information Vol. 24, No. 4, 2010 - Proposed International Nonproprietary Names, List 104
Temas:	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
Año:	2010 Páginas: 128
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	WHO Drug Information Vol. 25, No. 1, 2011 - Recommended International Nonproprietary Names, List 65
Temas:	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
Año:	2011 Páginas: 98
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global

Título:	WHO Drug Information Vol. 25, No. 2, 2011 - Proposed International Nonproprietary Names, List 105
Temas:	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
Año:	2011 Páginas: 120
Publicadores:	WHO Headquarters in Geneva
Regiones:	Global


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Última actualización: le 3 mayo 2013