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175 documents on 4 pages
 
close this section of the libraryQuality and Safety: Medicines
close this section of the libraryQuality Assurance
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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
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Regions: Global
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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
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Title: Accelerated Stability Studies of Widely Used Pharmaceutical Substances Under Simulated Tropical Conditions View the PDF document
Subjects: Quality and Safety: Medicines > Quality Assurance
Year: 1986 Pages: 119
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Regions: Global
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Title: Access to Medicines and Drug Regulation in Developing Countries: A Resource Guide for DFID
Subjects: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Author: Gray, Andy
Year: 2004 Pages: 16
Publishers:
Regions: Global
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Title: Act 368 - Sale of Drugs Act 1952 (Revised 1989). Incorporating Latest Amendment - Act A1084/2000
Subjects: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Year: 2000 Pages: 11
Publishers:
Countries: Malaysia
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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
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Regions: Global
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Title: Analysis of Legal Aspects of Local Pharmaceutical Production in Rwanda
Subjects: Medicine Access and Rational Use > Supply Management
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Year: 2006 Pages: 54
Publishers:
Countries: Rwanda
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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:
Regions: EAC East African Community
Countries: Kenya
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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:
Regions: Global
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Title: Assessment of Medicine Quality Assurance in Rwanda: Overview of Findings and Recommendations for Consideration. Kigali and Butare, Rwanda, November 9-13, 2009
Subjects: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Author: Coignez, Veerle; Hajjou, Mustapha; Smine, Abdelkrim
Year: 2009 Pages: 20
Publishers:
Countries: Rwanda
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Title: Basic Tests for Drugs - Pharmaceutical Substances, Medicinal Plant Materials and Dosage Forms [French] [Spanish] View the PDF document
Subjects: Quality and Safety: Medicines > Quality Assurance
Year: 1998 Pages: 100
Publishers:
Regions: Global
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Title: Basic Tests for Pharmaceutical Substances [French] [Spanish] View the PDF document
Subjects: Quality and Safety: Medicines > Quality Assurance
Year: 1986 Pages: 216
Publishers:
Regions: Global
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Title: Biosimilars. A Unique Opportunity for Iran National Health Sector and National Pharmaceutical Industry
Subjects: Medicine Information and Evidence for Policy > Medicines Policy
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Author: Cheraghali, Abdol Majid
Year: 2012 Pages: 4
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Countries: Iran (Islamic Republic of)
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Title: Brunei Darussalam Guidelines for Manufacturing and Handling of Halal Medicinal Products, Traditional Medicines and Health Supplements. Guidance Document GD24, First Edition, May 2010
Subjects: Traditional Medicine > Traditional, Complementary and Herbal Medicine
Quality and Safety: Medicines > Quality Assurance
Year: 2010 Pages: 34
Publishers:
Countries: Brunei Darussalam
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Title: Combating Counterfeit, Falsified and Substandard Medicines: Defining the Way Forward? Chatham House Briefing Paper, November 2010
Subjects: Quality and Safety: Medicines > Counterfeit Medicines
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Author: Clift, Charles
Year: 2010 Pages: 16
Publishers:
Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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Title: Does Price Reveal Poor-quality Drugs? Evidence from 17 Countries
Subjects: Medicine Access and Rational Use > Pricing
Quality and Safety: Medicines > Quality Assurance
Author: Bate, Roger; Jin, Ginger Zhe; Mathur. Aparna
Year: 2011 Pages: 43
Publishers:
Regions: Global
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Title: Drug Quality Control Laboratories
Subjects: Quality and Safety: Medicines > Quality Assurance
Year: 1999 Pages: 42
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Regions: Africa (AFRO)
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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:
Countries: Swaziland
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Title: Drug Regulation: History, Present and Future. In: van Boxtel CJ, Santoso B, Edwards IR eds., Drug Benefits and Risks: International Textbook of Clinical Pharmacology, Revised 2nd Ed. (Chapter 6). IOS Press and Uppsala Monitoring Centre, 2008
Subjects: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Author: Rägo, L; Santoso, Budiono
Year: 2008 Pages: 13
Regions: Global
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Title: The Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts) Rules, 1976 (Pakistan)
Subjects: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 1976 Pages: 10
Publishers:
Countries: Pakistan
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Title: Drugs Act, 2035, (1978). Act Number 21 of the Year 2053, 1978 (25 October 1978). An Act Made to Make Provisions Relating to Drugs - Nepal
Subjects: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Year: 1978 Pages: 15
Publishers:
Countries: Nepal
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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:
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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:
Regions: Global
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Title: Ensuring the Quality of Medicines in Resource-Limited Countries: An Operational Guide
Subjects: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Year: 2007 Pages: 207
Publishers:
Regions: Global
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Title: Exploratory Study on Active Pharmaceutical Ingredient Manufacturing for Essential Medicines
Subjects: Quality and Safety: Medicines > Quality Assurance
Author: Betsch, Ekkehard; Bumpas, Janet
Year: 2009 Pages: 52
Publishers:
Regions: Global
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Title: FIP Guidelines for the Labels of Prescribed Medicines (2001, Singapore) [French] [Spanish]
Subjects: Medicine Information and Evidence for Policy > Medicines Policy
Medicine Access and Rational Use > Rational Use
Quality and Safety: Medicines > Quality Assurance
Year: 2001 Pages: 4
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Regions: Global
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Title: FIP Statement of Policy on Counterfeit Medicines [French] [Spanish]
Subjects: Medicine Information and Evidence for Policy > Medicines Policy
Quality and Safety: Medicines > Counterfeit Medicines
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Year: 2003 Pages: 4
Publishers:
Related links:
Regions: Global
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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:
Regions: Global; America (AMRO)
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Title: Good Distribution Practices (GDP) for Pharmaceutical Products, 2009 - Egypt
Subjects: Quality and Safety: Medicines > Quality Assurance
Year: 2009 Pages: 37
Publishers:
Countries: Egypt
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Title: Good Laboratory Practice Regulations, 2008. Nigeria National Agency for Food and Drug Administration and Control (NAFDAC) Act 1993 (as amended)
Subjects: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Year: 2008 Pages: 23
Publishers:
Countries: Nigeria
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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
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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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:
Regions: Global
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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:
Regions: Global
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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
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Regions: Global
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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:
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Regions: Global
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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
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Regions: Global
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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
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Regions: Global
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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:
Regions: Global
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Title: Guide to Good Manufacturing Practice for Medicinal Products Part I - PIC/S, PE 009-8 (Part I), 15 January 2009
Subjects: Quality and Safety: Medicines > Quality Assurance
Year: 2009 Pages: 43
Publishers:
Regions: Global
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Title: Guide to Good Manufacturing Practice for Medicinal Products Part II - PIC/S, PE 009-8 (Part II), 15 January 2009. Developed by the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use
Subjects: Quality and Safety: Medicines > Quality Assurance
Year: 2009 Pages: 55
Publishers:
Regions: Global
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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:
Regions: Global
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Title: Guideline on Medication Error Reporting, First Edition, July 2009 - Malaysia
Subjects: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Safety and Efficacy
Year: 2009 Pages: 30
Publishers:
Countries: Malaysia
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Title: Guidelines for Clinical Lab Standards - QASD, MOH Bhutan
Subjects: Quality and Safety: Medicines > Quality Assurance
Year: 2009 Pages: 84
Publishers:
Countries: Bhutan
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Title: Guidelines for Good Clinical Practice (GCP) Inspection. First Edition (Version 1.0), October 2010
Subjects: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Year: 2010 Pages: 46
Publishers:
Countries: Malaysia
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Title: Guidelines for Good Distribution Practices for Pharmaceuticals - Kenya. First Edition, June 2006
Subjects: Medicine Access and Rational Use > Supply Management
Quality and Safety: Medicines > Quality Assurance
Year: 2006 Pages: 22
Publishers:
Countries: Kenya
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Title: Guidelines for Importation of Chemicals in Nigeria NAFDAC/NCS/002/00. Directorate of Narcotics and Controlled Substances, Chemical Import Control
Subjects: Medicine Access and Rational Use > Controlled Medicines
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Pages: 6
Publishers:
Countries: Nigeria
 
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Last updated: May 3, 2013