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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425 documents on 1 page
 
 
 
 
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Access to Orphan Drugs: A Comprehensive Review of Legislations, Regulations and Policies in 35 Countries

Year:

2015;

Pages:

24;

Regions:

 
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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 the Medicines Regulatory System in Angola: Report

Year:

2013;

Pages:

35;


Countries:

 
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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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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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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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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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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;


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

Year:

2012;

Pages:

1088;


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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;


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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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Regulatory Framework for Access to Safe, Effective Quality Medicines

Year:

2014;

Pages:

9;

Regions:

 
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Strengthening the Capacity of the Namibia Medicines Regulatory Council in the Regulation of Antiretroviral Medicines and Other Essential Pharmaceuticals

Year:

2014;

Pages:

78;


Countries: