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Title:
Description:
marketing authorization
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:
Criteria and Procedure of Drug Registration. Decree Number: HK.00.05.3.1950 - Indonesia
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Year:
2003
Pages:
21
Publishers:
Indonesia - National Agency of Drug and Food Control
Countries:
Indonesia
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:
Drugs (Import & Export) Rules, 1976 (Pakistan)
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Year:
1976
Pages:
26
Publishers:
Pakistan Government
Countries:
Pakistan
Title:
Gesamte Rechtsvorschrift für Arzneimittelgesetz, Fassung vom 29.04.2010. Bundesgesetz vom 2. März 1983 über die Herstellung und das Inverkehrbringen von Arzneimitteln (Arzneimittelgesetz - AMG) StF: BGBl. Nr. 185/1983...(German Version). Legislation on Drug Law, as Amended on 4/29/2010. Federal Law of 2 March 1983 on the Manufacture and Marketing of Pharmaceutical Products (Medicines Act - AMG) StF: BGBl No. 185/1983...
Year:
2010
Pages:
84
Publishers:
Austrian Federal Chancellery
Countries:
Austria
Title:
Good Laboratory Practice Regulations, 2008. Nigeria National Agency for Food and Drug Administration and Control (NAFDAC) Act 1993 (as amended)
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Quality and Safety: Medicines
>
Regulatory Support
Quality and Safety: Medicines
>
Safety and Efficacy
Year:
2008
Pages:
23
Publishers:
Nigeria Ministry of Health - National Agency for Food and Drug Administration and Control (NAFDAC)
Countries:
Nigeria
Title:
Good Pharmacovigilance Practice Regulations 2009. Nigeria National Agency for Food and Drug Administration and Control (NAFDAC) Act 1993 (as amended)
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Quality and Safety: Medicines
>
Safety and Efficacy
Year:
2009
Pages:
4
Publishers:
Nigeria Ministry of Health - National Agency for Food and Drug Administration and Control (NAFDAC)
Countries:
Nigeria
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 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 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:
Impact of Regulatory Requirements on Medicines Access in African Countries. Piasa Member Survey Results
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Author:
Narsai, Kirti
Year:
2010
Pages:
19
Publishers:
Pharmaceutical Industry Association of South Africa (PIASA)
Regions:
Africa (AFRO)
Countries:
South Africa
Title:
Licensing Information - Egypt
Pages:
19
Publishers:
Egypt Minister of Health & Population
Countries:
Egypt
Title:
Medicines Rules & Regulations, Kingdom of Bhutan 2005
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Year:
2005
Pages:
43
Publishers:
Bhutan Medicines Board
Countries:
Bhutan
Title:
MHLW Ministerial Ordinance No. 136, 2004. Ministerial Ordinance on Standards for Quality for Drugs, Quasi-drugs, Cosmetics and Medical Devices - Japan
Subjects:
Medicine Information and Evidence for Policy
>
Information and Publications
Quality and Safety: Medicines
>
Quality Assurance
Quality and Safety: Medicines
>
Regulatory Support
Year:
2004
Pages:
16
Publishers:
Japan - Ministry of Health, Labour and Welfare (MHLW)
Countries:
Japan
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:
Pharmaceuticals: Drug Regulation in Low and Middle Income Countries. World Bank, HNP Brief #4
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Quality and Safety: Medicines
>
Regulatory Support
Author:
Seiter, Andreas
Year:
2005
Pages:
4
Publishers:
The World Bank (WB)
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:
Profile of Services, 2010 (Pharmaceuticals and Medical Devices Agency, PMDA - Japan)
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Quality and Safety: Medicines
>
Safety and Efficacy
Year:
2010
Pages:
36
Publishers:
Japan - Pharmaceuticals and Medical Devices Agency
Countries:
Japan
Title:
PSI Guidelines on the Sourcing, Storage and Disposal of Medicinal Products (for Sale or Supply) Within a Retail Pharmacy Business
Subjects:
Medicine Access and Rational Use
>
Supply Management
Quality and Safety: Medicines
>
Regulatory Support
Year:
2011
Pages:
48
Publishers:
Pharmaceutical Society of Ireland (PSI)
Countries:
Ireland
Title:
Quality Assurance for Pharmaceuticals. (MDS-3: Managing Access to Medicines and Health Technologies, Chapter 19)
Subjects:
Medicine Information and Evidence for Policy
>
Medicines Policy
Quality and Safety: Medicines
>
Quality Assurance
Quality and Safety: Medicines
>
Regulatory Support
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Author:
Layloff, Thomas
Year:
2012
Pages:
23
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:
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 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:
REGULATION (EC) No 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 Laying Down Community Procedures for the Authorisation and Supervision of Medicinal Products for Human and Veterinary Use and Establishing a European Medicines Agency
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Quality and Safety: Medicines
>
Regulatory Support
Quality and Safety: Medicines
>
Safety and Efficacy
Year:
2004
Pages:
33
Publishers:
European Union (EU)
Regions:
EU European Union
Title:
Regulation of Manufacture of Drugs, DRUG ACT, 1976 (Pakistan)
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Quality and Safety: Medicines
>
Regulatory Support
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Year:
1976
Pages:
48
Publishers:
Pakistan Ministry of Health
Countries:
Pakistan
Title:
Regulatory Scientific Advice in Drug Development: Does Company Size Make a Difference?
Subjects:
Quality and Safety: Medicines
>
Regulatory Support
Author:
Gispen-De Wied, Christine C.
;
Hoes, Arno W.
;
Leufkens, Hubert G
;
Mantel-Teeuwisse, Aukje K.
;
Putzeist, Michelle
Year:
2010
Pages:
8
Regions:
Europe (EURO)
Countries:
Netherlands
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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Last updated: May 3, 2013