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Title:
Description:
registration of pharmaceuticals
Title:
Annual Report of Pharmacy Council, March 2010 - March 2011 - St. Vincent and the Grenadines.
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Year:
2010
Pages:
8
Publishers:
St. Vincent and the Grenadines, Ministry of Health & the Environment
Countries:
Saint Vincent and the Grenadines
Title:
Application for Marketing Authorization of a Pharmaceutical Product - Maldives Food and Drug Authority
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Year:
2006
Pages:
5
Publishers:
Republic of Maldives, Ministry of Health & Family
Countries:
Maldives
Title:
Consolidated List of Products - Whose Consumption and/or Sale Have Been Banned, Withdrawn, Severely Restricted or not Approved by Governments, Fourteenth Issue (New data only) (January 2005 – October 2008)- Pharmaceuticals. United Nations – New York, 2009
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Quality and Safety: Medicines
>
Safety and Efficacy
Year:
2009
Pages:
94
Publishers:
United Nations (UN)
Regions:
Global
Title:
Consolidated List of Products - Whose Consumption and/or Sale Have Been Banned, Withdrawn, Severely Restricted or Not Approved by Governments, Twelfth Issue - Pharmaceuticals. United Nations - New York, 2005
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Quality and Safety: Medicines
>
Safety and Efficacy
Year:
2005
Pages:
598
Publishers:
United Nations (UN)
Regions:
Global
Title:
Drug Registration Guidance Document, April 2011 Revision
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Year:
2011
Pages:
231
Publishers:
Malaysia - National Pharmaceutical Control Bureau (NPCB)
Countries:
Malaysia
Title:
Drug Regulation: History, Present and Future. In: van Boxtel CJ, Santoso B, Edwards IR eds., Drug Benefits and Risks: International Textbook of Clinical Pharmacology, Revised 2nd Ed. (Chapter 6). IOS Press and Uppsala Monitoring Centre, 2008
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Quality and Safety: Medicines
>
Regulatory Support
Author:
Rägo, L
;
Santoso, Budiono
Year:
2008
Pages:
13
Regions:
Global
Title:
Drugs Registration Rules, 2038 (1981). (Publication in Nepal Gazette, 3 Aug. 1981)
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Year:
1981
Pages:
41
Publishers:
Nepal Government
Countries:
Nepal
Title:
Guide to Application for Registration of Medicinal Products, 2nd Edition, October 2008 - Brunei Darussalam
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Year:
2008
Pages:
117
Publishers:
Brunei Darussalam - Ministry of Health, Department of Pharmaceutical Services
Countries:
Brunei Darussalam
Title:
Guidelines for Advertisement of Regulated Products in Nigeria NAFDAC/RR/019/00. Registration & Regulatory Affairs Directorate
Subjects:
Medicine Access and Rational Use
>
Rational Use
Quality and Safety: Medicines
>
Regulatory Support
Pages:
3
Publishers:
Nigeria Ministry of Health - National Agency for Food and Drug Administration and Control (NAFDAC)
Countries:
Nigeria
Title:
Guidelines for Application for Registration of Medicinal Products - Kingdom of Bhutan
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Year:
2006
Pages:
10
Publishers:
Bhutan - Drug Reguatory Authority, Ministry of Health
Countries:
Bhutan
Title:
Guidelines for Importation and Export of Pharmaceuticals - National Drug Authority, Uganda
Subjects:
Medicine Access and Rational Use
>
Supply Management
Quality and Safety: Medicines
>
Regulatory Support
Pages:
4
Publishers:
Uganda - National Drug Authority (NDA), Ministry of Health
Related links:
http://www.nda.or.ug/drug-insp.php
Countries:
Uganda
Title:
Guidelines for registration of Imported Drug Products in Nigeria NAFDAC/RR/02/00. Directorate of Registration and Regulatory Affairs
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Pages:
7
Publishers:
Nigeria Ministry of Health - National Agency for Food and Drug Administration and Control (NAFDAC)
Countries:
Nigeria
Title:
Guidelines on Drug Registration Applications in Bostwana. First Revised Edition, March 2000
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Year:
2000
Pages:
29
Publishers:
Botswana - Drugs Advisory Board
Countries:
Botswana
Title:
Guidelines on the Registration of Pharmaceuticals for Human Use in Uganda, Revised July 2006
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Year:
2006
Pages:
16
Publishers:
Uganda - National Drug Authority (NDA), Ministry of Health
Countries:
Uganda
Title:
Impact of Regulatory Requirements on Medicine Registration in African Countries – Perceptions and Experiences of Pharmaceutical Companies in South Africa - Southern Med Review Vol 5 Issue 1 July 2012
Subjects:
Medicine Information and Evidence for Policy
>
Information and Publications
Quality and Safety: Medicines
>
Regulatory Support
Author:
Mantel-Teeuwisse, Aukje K.
;
Narsai, Kirti
;
Williams, Abeda
Year:
2012
Pages:
7
Countries:
South Africa
Title:
Instruction on Drug Registration, Manufacture and Imports - Iran, 2009
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Year:
2009
Pages:
5
Publishers:
Iran - Ministry of Health and Medical Education
Countries:
Iran (Islamic Republic of)
Title:
Manuel de procédures pour l'enregistrement des médicaments multi-sources. Mali, Août 2008
Subjects:
Qualité et innocuité des médicaments
>
Assurance de la qualité
Qualité et innocuité des médicaments
>
Soutien en matière de réglementation
Year:
2008
Pages:
43
Publishers:
Mali, Direction de la Pharmacie et du Médicament
Countries:
Mali
Title:
Minister of Health Decision No. 297 of 2009 Concerning The Rules and Procedures for Registration of Biological Products, Serums, Vaccines and Blood Products - Egypt, 2009
Year:
2009
Pages:
20
Publishers:
Egypt Minister of Health & Population
Countries:
Egypt
Title:
National Pharmaceutical Control Bureau, Annual Report 2009 - Malaysia
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Quality and Safety: Medicines
>
Regulatory Support
Quality and Safety: Medicines
>
Safety and Efficacy
Year:
2010
Pages:
97
Publishers:
Malaysia - National Pharmaceutical Control Bureau (NPCB)
Countries:
Malaysia
Title:
Pharmaceutical Legislation and Regulation. (MDS-3: Managing Access to Medicines and Health Technologies, Chapter 6)
Subjects:
Medicine Information and Evidence for Policy
>
Medicines Policy
Quality and Safety: Medicines
>
Regulatory Support
Author:
Fefer, Enrique
Year:
2012
Pages:
21
Publishers:
Management Sciences for Health (MSH)
Related documents:
MDS-3: Managing Access to Medicines and Health Technologies (Third Edition)
Related links:
http://www.msh.org/resource-center/mds-3-digital-edition.cfm
Regions:
Global
Title:
Pharmacists' Regulations (4933) - Medicinal Products. Israel, 23 May 1986
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Year:
1986
Pages:
18
Publishers:
Israel - Israel's parliament, the Knesset
Countries:
Israel
Title:
Promulgation of Medicines and Related Substances Control Act, 2003 (Act No. 13 of 2003), of the Parliament - Government - Gazette No. 3051, Republic of Namibia
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Year:
2003
Pages:
39
Publishers:
Namibia, Office of the Prime Minister
Countries:
Namibia
Title:
Protección de los datos presentados para el registro de productos farmacéuticos - Implementación de las normas del acuerdo TRIPS
[
English
]
Subjects:
Acceso a los medicamentos y uso racional
>
Financiación
Calidad y seguridad de los medicamentos
>
Apoyo en materia de reglamentación
Author:
Correa, Carlos M
Year:
2002
Pages:
94
Publishers:
South Centre (SC)
Regions:
America (AMRO)
Title:
Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the Trips Agreement
[
Spanish
]
Subjects:
Medicine Access and Rational Use
>
Financing
Quality and Safety: Medicines
>
Regulatory Support
Author:
Correa, Carlos M
Year:
2002
Pages:
77
Publishers:
South Centre (SC)
Regions:
Global
Title:
Regional Assessment of Drug Registration and Regulatory Systems in CARICOM Member States and the Dominican Republic. Final Report, Volume I, July 2009
Subjects:
Medicine Information and Evidence for Policy
>
Monitoring and Evaluation
Quality and Safety: Medicines
>
Regulatory Support
Author:
Bannenberg, Wilbert
;
Kerr, Valerie
;
Schürmann, Marianne
;
Sigonda, Margareth
;
van Spengler, Victor
;
Verhoeven, Pascal
Year:
2009
Pages:
94
Publishers:
Health Research for Action (HERA)
Related documents:
Regional Assessment of Drug Registration and Regulatory Systems in CARICOM Member States and the Dominican Republic. Final Report, Volume II, July 2009: Countries and Regional Quality Control Laboratory
Regions:
America (AMRO)
;
CARICOM Caribbean Community / Communauté caribéenne / Comunidad del Caribe
Countries:
Dominican Republic
Title:
Regional Assessment of Drug Registration and Regulatory Systems in CARICOM Member States and the Dominican Republic. Final Report, Volume II, July 2009: Countries and Regional Quality Control Laboratory
Subjects:
Medicine Information and Evidence for Policy
>
Monitoring and Evaluation
Quality and Safety: Medicines
>
Regulatory Support
Author:
Bannenberg, Wilbert
;
Kerr, Valerie
;
Schürmann, Marianne
;
Sigonda, Margareth
;
van Spengler, Victor
;
Verhoeven, Pascal
Year:
2009
Pages:
147
Publishers:
Health Research for Action (HERA)
Related documents:
Regional Assessment of Drug Registration and Regulatory Systems in CARICOM Member States and the Dominican Republic. Final Report, Volume I, July 2009
Regions:
America (AMRO)
;
CARICOM Caribbean Community / Communauté caribéenne / Comunidad del Caribe
Countries:
Antigua and Barbuda
;
Bahamas
;
Barbados
;
Belize
;
Dominica
;
Dominican Republic
;
Grenada
;
Guyana
;
Haiti
;
Jamaica
;
Saint Kitts and Nevis
;
Saint Lucia
;
Saint Vincent and the Grenadines
;
Suriname
;
Trinidad and Tobago
Title:
Register of Licenced Medicines and Herbal Medicines as at 31st October 2008 - Zambia. Regulating Medicines for Public Health Protection
Subjects:
Medicine Programme Coordination
>
Programme Coordination
Quality and Safety: Medicines
>
Regulatory Support
Year:
2008
Pages:
76
Publishers:
Zambia, Pharmaceutical Regulatory Authority
Countries:
Zambia
Title:
Registering New Drugs for Low-Income Countries: The African Challenge
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Author:
Boulet, Pascale
;
Guzman, Javier
;
Moran, Mary
;
Wu, Lindsey
Year:
2011
Pages:
6
Related documents:
Registering New Drugs: The African Context. New Tools for New Times
Regions:
Global
;
Africa (AFRO)
Title:
Registering New Drugs: The African Context. New Tools for New Times
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Author:
Guzman, Javier
;
McDonald, Alina
;
Moran, Mary
;
Omune, Brenda
;
Wu, Lindsey
Year:
2010
Pages:
38
Publishers:
Drugs for Neglected Diseases Initiative (DNDi)
The George Institute for International Health, Health Policy Division
Related documents:
Registering New Drugs for Low-Income Countries: The African Challenge
Regions:
Global
;
Africa (AFRO)
Title:
Registration Guidelines, 2002 - Kingdom of Bahrain
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Year:
2002
Pages:
28
Publishers:
Bahrain (kingdom of), Ministry of Health, Pharmacy & Drug Control Directorate
Countries:
Bahrain (Kingdom of)
Title:
Registration of Drugs, Drug Act 1976 (Pakistan)
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Quality and Safety: Medicines
>
Regulatory Support
Year:
1976
Pages:
9
Publishers:
Pakistan Government
Countries:
Pakistan
Title:
Reglamento de Medicamentos (número 246-06) - República Dominicana
Subjects:
Calidad y seguridad de los medicamentos
>
Garantía de calidad
Calidad y seguridad de los medicamentos
>
Apoyo en materia de reglamentación
Year:
2006
Pages:
89
Publishers:
República Dominicana - Secretaría de Estado de Salud Pública y Asistencia Social (SESPAS)
Countries:
Dominican Republic
Title:
Reglamento del Sistema Nacional de Control de Productos Farmacéuticos. Dto. N° 1876, de 1995 (actualizado a enero 2005) - Chile
Subjects:
Calidad y seguridad de los medicamentos
>
Garantía de calidad
Calidad y seguridad de los medicamentos
>
Apoyo en materia de reglamentación
Year:
1996
Pages:
68
Publishers:
Chile, Ministerio de Salud (MINSAL)
Countries:
Chile
Title:
Situación de los Productos Farmacéuticos con Registro Sanitario vigente a Diciembre del año 2009 - Perú
Subjects:
Calidad y seguridad de los medicamentos
>
Apoyo en materia de reglamentación
Year:
2010
Pages:
27
Publishers:
Perú, Ministerio de Salud - Dirección General de Medicamentos, Insumos y Drogas
Countries:
Peru
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