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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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2nd Biennial Scientific Conference on Medicines Regulation in Africa. Addis Ababa, Ethiopia, 30th November to 1st December 2015 - Book of Abstracts. Conference Theme: Regulatory Systems Strengthening for advancing Research, Innovation and Local Pharmaceutical Production in Africa

Year:

2015;

Pages:

38;


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Access to Orphan Drugs: A Comprehensive Review of Legislations, Regulations and Policies in 35 Countries

Year:

2015;

Pages:

24;

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African Medicines Agency: Briefing Notes. First Meeting of the Specialized Technical Committee on Health, Population and Drug Control (STC-HPDC-1), Addis Ababa, Ethiopia, 13-17 April 2015

Year:

2015;

Pages:

4;


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African Medicines Agency: Settings Milestones towards its Establishment, 1st African Ministers of Health meeting jointly convened by the AUC and WHO, Luanda, Angola, 14-17/04/2014

Year:

2014;

Pages:

8;


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Alternative Regulatory Models for Pharmaceutical Promotions Involving Civil Society and Other Non-Government Stakeholders

Year:

2015;

Pages:

99;


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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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Assessment of Regulatory Impacts on Pharmaceutical Promotion. Bishkek, 2015 - Kyrgyzstan

Year:

2015;

Pages:

60;


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Assessment of the Medicines Regulatory System in Angola: Report

Year:

2013;

Pages:

35;


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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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Compendium of Medicines Evaluation and Registration for Medicine Regulation Harmonization in The East African Community, 2014

Year:

2014;

Pages:

312;


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Compendium of Quality Management System (QMS) Technical Documents for Harmonization of Medicines Regulation in the East African Community, 2104

Year:

2014;

Pages:

172;


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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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Essential Laws for Medicines Access - A Pilot Study on National Legislation (Australia, The Netherlands, South Africa and Tonga). Report to the WHO-EMP Department on work undertaken in Geneva, June-August 2010

Year:

2014;

Pages:

38;


 
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Ethical Criteria for Medicinal Drug Promotion [French] [Russian] [Spanish] View the PDF document

Year:

1988;

Pages:

8;


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Évaluation de la régulation du secteur pharmaceutique en Guinée. Mission de juillet à septembre 2012, SIAPS Guinée

Year:

2012;

Pages:

96;


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Fact or Fiction? What Healthcare Professionals Need to Know about Pharmaceutical Marketing in the European Union

Year:

2016;

Pages:

72;


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Farmacovigilancia, hacia una mayor seguridad en el uso de medicamentos - 2012

Year:

2012;

Pages:

329;


 
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Final report and Recommendations to the Ministries of Health. ATOME (Access to Opioid Medication in Europe)

Year:

2014;

Pages:

156;


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Final Report and Recommendations to the Ministries of Health; Annex, November 2014. ATOME (Access to Opioid Medication in Europe)

Year:

2014;

Pages:

595;


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First African Medicines Regulatory Authorities Conference - Final Report. Addis Ababa, Ethiopia, 31 October – 3 November 2005

Year:

2009;

Pages:

50;


 
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First Biennial Scientific Conference on Medicines Regulation in Africa. Johannesburg, Afrique du Sud, 2–3 December 2013 - Book of Abstracts. Conference Theme: Building Partnerships for Sustainable Capacity Development in Medicines Regulation in Africa [French]

Year:

2013;

Pages:

72;


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First Biennial Scientific Conference on Medicines Regulation in Africa. Johannesburg, South Africa, 2-3 December, 2013 - Conference Report. Conference Theme: Building Partnerships for Sustainable Capacity Development in Medicines Regulation in Africa

Year:

2013;

Pages:

84;


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First meeting of African Ministers of Health jointly convened by the AUC and WHO. Luanda, Angola, 14–15 April 2014 - Volume 2: Experts' Meeting

Year:

2014;

Pages:

84;


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Governance and Pharmacovigilance in Brazil: A Scoping Review

Year:

2016;

Pages:

15;

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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 Registration of Medicines. Third Edition, June 2014 - Ethiopia

Year:

2014;

Pages:

141;


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Guidelines for the Regulation of Herbal Medicines in the South-East Asia Region. Developed at the Regional Workshop on the Regulation of Herbal Medicines, Bangkok, 24-26 June 2003

Year:

2004;

Pages:

30;


 
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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;


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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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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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Lignes directrices pour la préparation et la soumission de dossiers en format document technique commun. Septembre 2015 - République démocratique du Congo

Year:

2015;

Pages:

33;


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Lignes directrices relatives a l’homologation des médicaments à base des plantes. Septembre 2015 - République démocratique du Congo

Year:

2015;

Pages:

18;


 
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Lignes directrices relatives au dépôt des demandes d’enregistrement au format CTD (common technical document) : qualité. Septembre 2015 - République démocratique du Congo

Year:

2015;

Pages:

62;


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Lignes directrices sur la biodisponibilité/bioéquivalence. Septembre 2015 - République démocratique du Congo

Year:

2015;

Pages:

54;


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Lignes directrices sur la stabilité. Septembre 2015 - République démocratique du Congo

Year:

2015;

Pages:

33;


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

Year:

2012;

Pages:

1088;


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Meeting of the NEPAD Regional Centers of Regulatory Excellence (RCORES) in Pharmacovigilance. May 14–15, 2015, Accra, Ghana. Report of Proceedings

Year:

2015;

Pages:

30;


 
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National Drug Law - Union of Myanmar. (The State Law and Order Restoration Council Law No. 7/92. The 5th Waning Day of Tazaungmon, 1354 M.E. 30th October, 1992)

Year:

1992;

Pages:

9;


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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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National Medicines Regulatory Authority Act, No. 5 of 2015. (Published as a Supplement to Part II of the Gazette of the Democratic Socialist Republic of Sri Lanka of March 20, 2015)

Year:

2015;

Pages:

98;


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