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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159 documents on 1 page
 
 
 
 
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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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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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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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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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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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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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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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Regulatory Framework for Access to Safe, Effective Quality Medicines

Year:

2014;

Pages:

9;

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WHA67.20 - Regulatory System Strengthening for Medical Products. WHA resolution; Sixty-seventh World Health Assembly, 2014. WHA resolution; Sixty-seventh World Health Assembly, 2014 (Chinese version) 加强医疗产品管制系统; 第六十七届世界卫生大会 [Arabic] [English] [French] [Russian] [Spanish]

Year:

2014;

Pages:

5;


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WHA67.20 - Regulatory System Strengthening for Medical Products. WHA resolution; Sixty-seventh World Health Assembly, 2014. WHA Resolution; Sixty-seventh World Health Assembly, 2014 (Russian version) WHA67.20 - Укрепление нормативной системы для медицинской продукции. Всемирная ассамблея здравоохранения, 67 сессия [Arabic] [Chinese] [English] [French] [Spanish]

Year:

2014;

Pages:

6;


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WHA67.20 - Renforcement des systèmes de réglementation des produits médicaux. WHA résolution; Soixante-Septième Assemblée mondiale de la Santé, 2014 [Arabic] [Chinese] [English] [Russian] [Spanish]

Year:

2014;

Pages:

6;


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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

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Year:

2015;

Pages:

24;


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WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 992 - Forty-ninth Report (Geneva, 13–17 October 2014)

Year:

2015;

Pages:

228;


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WHO Rotational Fellowships: An Update - Prequalification. (WHO Drug Information Vol. 30, No. 1, 2016)

Year:

2016;

Pages:

6;


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