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Title:
Description:
marketing authorization
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:
Autorisation de mise sur le marché des médicaments à usage humain notamment d'origine multisource (génériques). Manuel à l’usage des autorités de réglementation pharmaceutique - Série Réglementation Pharmaceutique, No. 13
Year:
2008
Pages:
236
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 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:
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:
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:
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:
Requisitos armonizados para el registro de vacunas en la Región de las Américas y Guía para la preparación de una solicitud de registro sanitario. Red PARF Documento Técnico No. 1 (Red Panamericana de Armonización de la Reglamentación Farmacéutica), Noviembre de 2008
Subjects:
Calidad y seguridad de los medicamentos
>
Garantía de calidad
Calidad y seguridad de los medicamentos
>
Apoyo en materia de reglamentación
Calidad y seguridad de los medicamentos
>
Seguridad y eficacia
Year:
2010
Pages:
38
Publishers:
World Health Organization - Regional Office for the Americas (WHO/AMRO/PAHO)
Regions:
America (AMRO)
Title:
Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products. WHO Technical Report Series, No. 953, 2009 - Annex 2. (With Table 2 - Updated 1 December 2010)
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Year:
2009
Pages:
50
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Medicines Regulatory Package. A Collection of Tools for Medicines Regulatory Authorities - Regulatory Support Series No. 014
Year:
2011
Publishers:
WHO Headquarters in Geneva
Regions:
Global
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Last updated: May 3, 2013