Subjects

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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391 documents on 1 page
 
 
 
 
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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;

Regions:

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

Year:

2012;

Pages:

73;


Countries:

 
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Boas Práticas da OMS para Laboratórios de Controle de Qualidade de Produtos Farmacêuticos (Série de Relatórios Tecnicos da OMS, No. 957, 2010 - Relatório 44, Anexo 1) e Documento de Auto-Avaliação de Boas Práticas de Laboratório (BPL) - Rede PARF Documento Técnico No. 9 (Rede Pan-Americana da Harmonização de Regulamentação Farmacêutica) [English] [French] [Spanish] [Thai]

Year:

2011;

Pages:

58;


 
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Boas práticas da OMS para laboratórios de microbiologia farmacêutica - Rede PARF Documento Técnico Nº 11 (Rede Pan-Americana da Harmonização de Regulamentação Farmacêutica) [English]

Year:

2012;

Pages:

37;


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

Year:

2012;

Pages:

5;

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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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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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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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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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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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Legislación reglamentaria nacional en materia de fármacos: Principios orientadores para pequeños servicios de reglamentación farmacéutica. OMS, Serie de Informes Técnicos, No. 885, 1999, Annex 8 [English]

Year:

1999;

Pages:

44;


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Marco para la Ejecución de los Requisitos de Equivalencia para los Productos Farmacéuticos - Red PARF Documento Técnico Nº 8 (Red Panamericana de Armonización de la Reglamentación Farmacéutica) [English]

Year:

2011;

Pages:

40;


 
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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;


Countries:

 
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Monitoring the Quality of Antimalarial Medicines Circulating in Kenya, 2012

Year:

2012;

Pages:

37;


Countries:

 
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Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability. WHO Technical Report Series, No. 992, 2015, Annex 7

Year:

2015;

Pages:

54;


Regions:

 
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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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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;


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;


Regions:

 
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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;


Regions:

 
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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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WHA 16.36 - Клиническая и фармакологическая оценка фармацевтических препаратов. Всемирная ассамблея здравоохранения, 16 сессия, 1963 / WHA16.36 - Clinical and Pharmacological Evaluation of Drugs. WHA resolution; The Sixteenth World Health Assembly, 1963 [English] [French] [Spanish]

Year:

1963;

Pages:

3;


Regions:

 
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WHA17.39 - Клиническая и фармакологическая оценка лекарственных препаратов. Всемирная ассамблея здравоохранения, 17 сессия / (WHA17.39 - Clinical and Pharmacological Evaluation of Drugs. WHA resolution; The Seventeenth World Health Assembly, 1964) [English] [French] [Spanish]

Year:

1964;

Pages:

2;


Regions:

 
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WHA18.42 - Система контроля за вредными воздействиями лекарственных препаратов. Всемирная ассамблея здравоохранения, 18 сессия, 1965 / WHA18.42 - Adverse Drug Reaction Monitoring System. WHA resolution; The Eighteenth World Health Assembly, 1965 [English] [French] [Spanish]

Year:

1965;

Pages:

2;


Regions:

 
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WHA24.56 - Качество, безопасность и эффективность лекарственных препаратов. Всемирная ассамблея здравоохранения, 24 сессия / WHA24.56 - Quality, safety and efficacy of drugs. WHA resolution; The Twenty-fourth World Health Assembly, 1971 [English] [French] [Spanish]

Year:

1971;

Pages:

2;


Regions:

 
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WHA67.21 - Access to Biotherapeutic Products Including Similar Biotherapeutic Products and Ensuring Their Quality, Safety and Efficacy. WHA Resolution; Sixty-seventh World Health Assembly, 2014. (Russian version) WHA67.21 - Доступ к биотерапевтической продукции, включая аналогичную биотерапевтическую продукцию, и обеспечение ее качества, безопасности и эффективности. Всемирная ассамблея здравоохранения, 67 сессия [Arabic] [Chinese] [English] [French] [Spanish]

Year:

2014;

Pages:

3;