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On this page readers can obtain a listing of documents under the subject headings. Click on the name of a subject heading to display the sub-headings, or to return to the main subjects. Click on the icon of a sub-heading to obtain the concerned documents. Publications are available in HTML, PDF , DOC or XLS format. Click on the corresponding icon to open the publication. The PDF icon located on the cover page of a publication represents that the publication is available only in PDF format. If the PDF icon is located near the title of the publication it means the document is available in both HTML and PDF formats.
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Addressing the Barriers to Effective Monitoring, Reporting and Containment of Spurious/Substandard/Falsely-labelled/ Falsified/Counterfeit Medical Products through Sustainable Multi-stakeholder Collaboration and Community/Consumer-based Interventions. A report prepared for the Medicines Transparency Alliance, Philippines

Year:

2016;

Pages:

94;


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Analysis of the Regulatory Capacity to Assure the Quality of Antimalarial Medicines in Selected Countries of the Greater Mekong Subregion of Asia. March 2015

Year:

2015;

Pages:

110;


 
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Antimicrobial Resistance: What Does Medicine Quality Have to Do with It?

Year:

2015;

Pages:

45;

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Assessment of the Regulatory Systems and Capacity of the Directorate General for Drug Administration in Bangladesh

Year:

2012;

Pages:

73;


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Building Clinical Trial Capacity to Develop a New Treatment for Multidrug-resistant Tuberculosis. (Bull World Health Organ 2016;94:147–152)

Year:

2016;

Pages:

6;


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Building Clinical Trials Capacity for Tuberculosis Drugs in High-Burden Countries

Year:

2007;

Pages:

4;

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Clinical Trials Have Gone Global: Is This a Good Thing?

Year:

2012;

Pages:

5;

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Collaborative Procedure Between the World Health Organization (WHO) Prequalification Team and National Regulatory Authorities in the Assessment and Accelerated National Registration of WHO-prequalified Pharmaceutical Products and Vaccines. WHO Technical Report Series, No. 996, 2016, Annex 8

Year:

2016;

Pages:

42;


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Compendium of Good Manufacturing Practices (GMP) Technical Documents for Harmonization of Medicines Regulation in The East African Community, 2014

Year:

2014;

Pages:

336;


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Concept paper for discussion: A stepwise approach for pharmaceutical companies in developing countries to attain WHO GMP standards. (WHO Drug Information Vol. 30, No. 2, 2016)

Year:

2016;

Pages:

13;


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Development of a Risk-Based Approach and Tools for Improving Safe and Rational Use of Tuberculosis Medicines

Year:

2013;

Pages:

40;


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Development of National Health Laboratory Policy and Plan

Year:

2011;

Pages:

36;


 
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Documento de Autoevaluación de Buenas Prácticas de Laboratorio (BPL) / Documento de Auto-Avaliação de Boas Práticas de Laboratório (BPL) / Document on Self-Evaluation of Good Laboratory Practices (GLP) - Red PARF Documento Técnico No. 6 (Red Panamericana de Armonización de la Reglamentación Farmacéutica)

Year:

2011;

Pages:

113;


 
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Emergency Use Assessment and Listing Procedure (EUAL) for Candidate in Vitro Diagnostics (IVDs) for Use in the Context of a Public Health Emergency

Year:

2015;

Pages:

11;


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Emergency Use Assessment and Listing Procedure (EUAL) for Candidate Medicines for Use in the Context of a Public Health Emergency

Year:

2015;

Pages:

9;


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Emergency Use Assessment and Listing Procedure (EUAL) for Candidate Vaccines for Use in the Context of a Public Health Emergency

Year:

2015;

Pages:

10;


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Estudio sobre las Condiciones Actuales de los Laboratorios Oficiales de Control de Calidad de Medicamentos (LOCM) en América Latina y el Caribe / World Health Organization (WHO) Study of the Current Conditions of the Official Medicine Control Laboratories (OMCL) in Latin America and the Caribbean / Estudo sobre as Condições Atuais dos Laboratórios Oficiais de Controle da Qualidade de Medicamentos (LOCM) na América Latina e Caribe Farmacêutico - Red PARF Documento Técnico No. 4 (Red Panamericana de Armonización de la Reglamentación Farmacéutica)

Year:

2010;

Pages:

45;


 
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FIP–WHO Technical Guidelines: Points to Consider in the Provision by Health-care Professionals of Children-specific Preparations That Are Not Available as Authorized Products. WHO Technical Report Series, No. 996, 2016, Annex 2

Year:

2016;

Pages:

24;


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Framework for Implementation of Equivalence Requirements for Pharmaceutical Products - PANDRH Technical Report Nº8 (Pan American Network for Drug Regulatory Harmonization) [Spanish]

Year:

2011;

Pages:

38;


 
 
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Good Manufacturing Practice Guideline for Pharmaceutical Products: Main Principles. First Edition, 2014 - Ethiopia

Year:

2014;

Pages:

109;


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Guidance on Good Manufacturing Practices: Inspection Report. (Including Appendix 1: Guidance on Good Manufacturing Practices: Inspection Report; Appendix 2: Example of a Risk Category Assessment of the Site Depending on Level of Compliance and Inspection Frequency. WHO Technical Report Series, No. 996, 2016, Annex 4

Year:

2016;

Pages:

16;


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Guidance on the Selection of Comparator Pharmaceutical Products for Equivalence Assessment of Interchangeable Multisource (Generic) Products. WHO Technical Report Series, No. 992, 2015, Annex 8

Year:

2015;

Pages:

6;


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Guideline for Good Clinical Practice. ICH Harmonised Tripartite Guideline. E6(R1). Current Step 4 version, dated 10 June 1996. (including the Post Step 4 corrections). The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Year:

1996;

Pages:

59;


 
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Guideline for Good Storage Practices, Good Distribution Practice, and Pharmaceutical Product Recall. First Edition, September 2015 - Ethiopia

Year:

2015;

Pages:

71;


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Guideline for Registration of Medicines. Third Edition, June 2014 - Ethiopia

Year:

2014;

Pages:

141;


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Guidelines on Import Procedures for Pharmaceutical Products. WHO Technical Report Series, No. 863, 1996, Annex 12 (with Appendix: Special Import Controls for Narcotic Drugs and Psychotropic Substances)

Year:

2014;

Pages:

10;


Regions:

 
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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

Year:

2012;

Pages:

76;


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Guidelines on the Conduct of Surveys of the Quality of Medicines. WHO Technical Report Series, No. 996, 2016, Annex 7

Year:

2016;

Pages:

36;


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Implementation of Basic Quality Control Tests for Malaria Medicines in Amazon Basin Countries: Results for the 2005–2010 Period

Year:

2012;

Pages:

11;


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Laboratory Quality Standards and their Implementation

Year:

2011;

Pages:

74;


 
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MDS-3: Managing Access to Medicines and Health Technologies (Third Edition)

Year:

2012;

Pages:

1088;


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Monitoring the Quality of Antimalarial Medicines Circulating in Kenya, 2011

Year:

2011;

Pages:

44;


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Monitoring the Quality of Antimalarial Medicines Circulating in Kenya, 2012

Year:

2012;

Pages:

37;


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NAFDAC Good Distribution Practices Guidelines For Pharmaceutical Products, 2016 - Nigeria

Year:

2016;

Pages:

57;


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NAFDAC Good Manufacturing Practice Guidelines for Parmaceutical Products, 2016 - Nigeria

Year:

2016;

Pages:

109;


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NAFDAC Good Practices For Pharmaceutical Quality Control Laboratories, 2016 - Nigeria

Year:

2016;

Pages:

74;


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National Drug Regulatory Legislation: Guiding Principles for Small Drug Regulatory Authorities. WHO Technical Report Series, No. 885, 1999, Annex 8 [Spanish]

Year:

1999;

Pages:

41;


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Quality and Availability of Selected Life-saving Reproductive Health Medicines in Developing Countries - Medicines for Women and Children. (WHO Drug Information Vol. 29, No. 3, 2015)

Year:

2015;

Pages:

10;


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Quality of Anti-Malarials Collected in the Private and Informal Sectors in Guyana and Suriname

Year:

2012;

Pages:

8;

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The Quality of Antimalarial Medicines in Western Cambodia: a Case Study Along the Thai-Cambodian Border

Year:

2013;

Pages:

14;


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Quality of Medicines Multi-Stakeholder Forum. Kampala, May 2015 - Uganda Medicines Transparency Alliance (MeTA)

Year:

2015;

Pages:

19;


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Registration and Quality Assurance of ARVs & Other Essential Medicines in Namibia. October 2014 - September 2015

Year:

2015;

Pages:

21;


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Regulatory Framework for Access to Safe, Effective Quality Medicines

Year:

2014;

Pages:

9;

Regions:

 
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Report on Post-Market Surveillance of First Line Anti-Tuberculosis Medicines in Kenya

Year:

2012;

Pages:

78;


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Screening Drug Quality Project. Report, March 2014 - Uganda Medicines Transparency Alliance (MeTA)

Year:

2014;

Pages:

27;


Countries:

 
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Screening Drug Quality Project. Report, November 2015 - Uganda Medicines Transparency Alliance (MeTA)

Year:

2015;

Pages:

35;


Countries:

 
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SIAPS Annual Report: Program Year 1, October 2011–September 2012. Systems for Improved Access to Pharmaceuticals and Services Program

Year:

2012;

Pages:

40;


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SIAPS Annual Report: Program Year 2, October 2012–September 2013. Systems for Improved Access to Pharmaceuticals and Services Program

Year:

2013;

Pages:

63;


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SIAPS Annual Report: Program Year 3, October 2013–September 2014. Systems for Improved Access to Pharmaceuticals and Services Program

Year:

2014;

Pages:

174;


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SIAPS Annual Report: Program Year 4, October 2014–September 2015. Systems for Improved Access to Pharmaceuticals and Services Program

Year:

2015;

Pages:

268;


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Strengthening Public Health Laboratories in the WHO African Region: a Critical Need for Disease Control

Year:

2010;

Pages:

6;


 
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Swaziland’s Innovative Approach to Improving Access to Quality Logistics Data for Decision Making

Year:

2013;

Pages:

2;


Countries:

 
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Technical Assistance for the Development of Pre-service and In-service Pharmacovigilance Curriculum at the Hanoi University of Pharmacy in Vietnam

Year:

2011;

Pages:

41;


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The Three-Level Approach: A Framework for Ensuring Medicines Quality in Limited-Resource Countries

Year:

2014;

Pages:

8;


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White Paper on UNIDO's GMP Roadmap Concept. Design of a Stepwise Approach for the Pharmaceutical Industry in Developing Countries to Comply with WHO GMP. Global UNIDO Project: Strengthening the local production of essential medicines in developing countries^through advisory and capacity building support

Author:

Year:

2015;

Pages:

24;


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WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce: Questions and Answers (Q & A). Adopted guidance. (WHO Drug Information Vol. 30, No. 3, 2016)

Year:

2016;

Pages:

13;


Regions: