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202 documents on 5 pages

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Quality and Safety: Medicines

Regulatory Support

Title:	13th International Conference of Drug Regulatory Authorities (ICDRA) Berne, Switzerland, 16-19 September 2008. ICDRA: Medicines Agencies Decide Future Action
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Year:	2008 Pages: 19
Publishers:	WHO Headquarters in Geneva
Related links:	http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/en/index.html
Regions:	Global

Title:	14th International Conference of Drug Regulatory Authorities(ICDRA), Singapore 30 November - 3 December 2010
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Year:	2011 Pages: 16
Publishers:	WHO Headquarters in Geneva
Related links:	http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/en/index.html

Title:	15th International Conference of Drug Regulatory Authorities (ICDRA), Tallinn, Estonia, 23–26 October 2012
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2012 Pages: 23
Publishers:	WHO Headquarters in Geneva
Related links:	http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/en/index.html
Regions:	Global

Title:	The Ability of Select Sub-Saharan African Countries to Utilise Trips Flexibilities and Competition Law to Ensure a Sustainable Supply of Essential Medicines: A Study of Producing and Importing Countries
Subjects:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Regulatory Support
Author:	Avafia, Tenu; Berger, Jonathan; Hartzenberg, Trudi
Year:	2006 Pages: 59
Publishers:	United Nations Conference on Trade and Development (UNCTAD ) Trade law centre for southern Africa (TRALAC)
Regions:	Africa (AFRO); SSA Sub-Saharan Africa

Title:	Access to ART and other Essential Medicines in Sub-Saharan Africa: Intellectual Property and Relevant Legislations, September 2007
Subjects:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Regulatory Support
Author:	Musungu, Sisule F.
Year:	2007 Pages: 37
Publishers:	United Nations Development Programme (UNDP)
Regions:	Africa (AFRO); SSA Sub-Saharan Africa

Title:	Access to Medicines and Drug Regulation in Developing Countries: A Resource Guide for DFID
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy
Author:	Gray, Andy
Year:	2004 Pages: 16
Publishers:	DFID Health Resource Centre
Regions:	Global

Title:	Act 234 - Dangerous Drugs Act 1952 (Revised 1980). Incorporating Latest Amendment - P.U.(A) 44 /2003 - Malaysia
Subjects:	Medicine Access and Rational Use > Controlled Medicines Quality and Safety: Medicines > Regulatory Support
Year:	2003 Pages: 55
Publishers:	Malaysia Ministry of Health
Countries:	Malaysia

Title:	Act 368 - Sale of Drugs Act 1952 (Revised 1989). Incorporating Latest Amendment - Act A1084/2000
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Year:	2000 Pages: 11
Publishers:	Malaysia Ministry of Health, Pharmaceutical Services Division
Countries:	Malaysia

Title:	African Medicines Registration Harmonisation (AMRH) Initiative: Summary, Status and Future Plans. The New Partnership for Africa’s Development (NEPAD) & the World Health Organization (WHO)
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2009 Pages: 13
Publishers:	WHO Headquarters in Geneva NEPAD - The New Partnership for Africa's Development / African Union (AU)
Related links:	http://www.afro.who.int/en/clusters-a-programmes/hss/essential-medicines/edm-publications.html
Regions:	Africa (AFRO)

Title:	Analysis of Legal Aspects of Local Pharmaceutical Production in Rwanda
Subjects:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Year:	2006 Pages: 54
Publishers:	German Technical Cooperation Agency (GTZ) / Deutsche Gesellschaft für Technische Zusammenarbeit (GTZ) GmbH
Countries:	Rwanda

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:	Antibiotics Act - Trinidad and Tobago
Subjects:	Medicine Access and Rational Use > Antimicrobial Drug Resistance Quality and Safety: Medicines > Regulatory Support
Year:	2007 Pages: 40
Publishers:	Ministry of Legal Affairs - Trinidad and Tobago
Countries:	Trinidad and Tobago

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:	Application of Hazard Analysis and Critical Control Point (HACCP) Methodology to Pharmaceuticals. WHO Technical Report Series, No. 908, 2003, Annex 7
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Year:	2003 Pages: 14
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Assessment of Medicine Quality Assurance in Rwanda: Overview of Findings and Recommendations for Consideration. Kigali and Butare, Rwanda, November 9-13, 2009
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Author:	Coignez, Veerle; Hajjou, Mustapha; Smine, Abdelkrim
Year:	2009 Pages: 20
Publishers:	United States Pharmacopeia (USP) USAID - Promoting the Quality of Medicines Program (PQM)
Countries:	Rwanda

Title:	Assessment of Medicines Regulatory Systems in Sub-Saharan African Countries. An Overview of Findings from 26 Assessment Reports
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2010 Pages: 48
Publishers:	WHO Headquarters in Geneva
Regions:	Africa (AFRO)

Title:	ATOME Scan of National Legislation. Results of the Quick Scan of National Legislation of Twelve European Countries (Work Package 7). ATOME (Access to Opioid Medication in Europe)
Subjects:	Medicine Access and Rational Use > Controlled Medicines Quality and Safety: Medicines > Regulatory Support
Author:	Mantel-Teeuwisse, Aukje K.; Schutjens, Marie‐Hélène; Vranken, Marjolein
Year:	2012 Pages: 6
Publishers:	Utrecht Institute for Pharmaceutical Sciences, Utrecht University
Regions:	Europe (EURO); EU European Union

Title:	Bill to Provide for the Establishment of Drug Regulatory Authority of Pakistan, 2012
Subjects:	Quality and Safety: Medicines > Regulatory Support Prequalification of Medicines > WHO-UNICEF-UN Project
Year:	2012 Pages: 28
Publishers:	Pakistan Government
Countries:	Pakistan

Title:	Biosimilars. A Unique Opportunity for Iran National Health Sector and National Pharmaceutical Industry
Subjects:	Medicine Information and Evidence for Policy > Medicines Policy Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Author:	Cheraghali, Abdol Majid
Year:	2012 Pages: 4
Related documents:	Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). WHO Expert Committee on Biological Standardization, 19-23 October 2009
Related links:	http://www.darujps.com/content/20/1/35
Countries:	Iran (Islamic Republic of)

Title:	Code of Conduct - COC. Pharmig Code of Conduct and Code of Procedures of the COC Committes of Experts of the 1st and 2nd Instance. Coming into force on 01/07/2007, Last amendment on 01/07/2009 (Austria)
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2009 Pages: 43
Publishers:	Pharmig – Association of the Austrian Pharmaceutical Industry
Countries:	Austria

Title:	Combating Counterfeit, Falsified and Substandard Medicines: Defining the Way Forward? Chatham House Briefing Paper, November 2010
Subjects:	Quality and Safety: Medicines > Counterfeit Medicines Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Author:	Clift, Charles
Year:	2010 Pages: 16
Publishers:	Chatham House (the Royal Institute of International Affairs) - Centre on Global Health Security
Regions:	Global

Title:	COMMISSION REGULATION (EC) - No. 1277/2005 of 27 July 2005 Laying Down Implementing Rules for Regulation (EC) - No. 273/2004 of the European Parliament and of the Council on Drug Precursors and for Council Regulation (EC) - No. 111/2005 Laying Down Rules for the Monitoring of Trade between the Community and Third Countries in Drug Precursors
Subjects:	Medicine Access and Rational Use > Controlled Medicines Quality and Safety: Medicines > Regulatory Support
Year:	2005 Pages: 27
Publishers:	European Union (EU)
Regions:	EU European Union

Title:	COMMISSION REGULATION (EC) - No. 297/2009 of 8 April 2009 Amending Regulation (EC) - No. 1277/2005 Laying Down Implementing Rules for Regulation (EC) - No. 273/2004 of the European Parliament and of the Council on Drug Precursors and for Council Regulation (EC) - No. 111/2005 Laying Down Rules for the Monitoring of Trade between the Community and Third Countries in Drug Precursors
Subjects:	Medicine Access and Rational Use > Controlled Medicines Quality and Safety: Medicines > Regulatory Support
Year:	2009 Pages: 3
Publishers:	European Union (EU)
Regions:	EU European Union

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:	Cosmetics, Devices and Drugs Act, No. 27 of 1980. Part I: Section (I) - General. The Gazette of the Democratic Socialist Republic of Sri Lanka, 378/3 - 1985
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	1985 Pages: 50
Publishers:	Sri Lanka Ministry of Healthcare and Nutrition
Countries:	Sri Lanka

Title:	COUNCIL REGULATION (EC) - No. 111/2005 of 22 December 2004 Laying Down Rules for the Monitoring of Trade between the Community and Third Countries in Drug Precursors
Subjects:	Medicine Access and Rational Use > Controlled Medicines Quality and Safety: Medicines > Regulatory Support
Year:	2005 Pages: 10
Publishers:	European Union (EU)
Regions:	EU European Union

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:	Developing World: Bring Order to Unregulated Health Markets
Subjects:	Quality and Safety: Medicines > Regulatory Support
Author:	Bloom, Gerald; Peters, David H
Year:	2012 Pages: 3
Regions:	Global

Title:	DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use (OJ L 311, 28.11.2001, p. 67)
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2001 Pages: 126
Publishers:	European Union (EU)
Regions:	EU European Union

Title:	DIRECTIVE 2005/36/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 September 2005 on the Recognition of Professional Qualifications
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2005 Pages: 121
Publishers:	European Union (EU)
Regions:	EU European Union

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:	Drug Seller Initiatives. (MDS-3: Managing Access to Medicines and Health Technologies, Chapter 32)
Subjects:	Medicine Information and Evidence for Policy > Medicines Policy Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Regulatory Support
Author:	Clark, Malcolm; Heltzer, Ned; Johnson, Keith; Staley, Robert
Year:	2012 Pages: 15
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:	The Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts) Rules, 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: 10
Publishers:	Pakistan Government
Countries:	Pakistan

Title:	Drugs (Import & Export) Rules, 1976 (Pakistan)
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	1976 Pages: 26
Publishers:	Pakistan Government
Countries:	Pakistan

Title:	Drugs Act - Law of Mongolia, Ulaanbaatar, 7 May 1998
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2002 Pages: 9
Publishers:	Mongolia - State Great Hural (Parliament of Mongolia)
Countries:	Mongolia

Title:	Drugs Act, 1976. Advertising of Drugs, Etc. (Pakistan)
Subjects:	Medicine Access and Rational Use > Rational Use Quality and Safety: Medicines > Regulatory Support
Year:	1976 Pages: 4
Publishers:	Pakistan Government
Countries:	Pakistan

Title:	Drugs Act, 2035, (1978). Act Number 21 of the Year 2053, 1978 (25 October 1978). An Act Made to Make Provisions Relating to Drugs - Nepal
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Year:	1978 Pages: 15
Publishers:	Nepal Government
Countries:	Nepal

Title:	The Drugs and Cosmetics Act and Rules. the Drugs and Cosmetics Act, 1940 (23 of 1940) (As Amended Up to the 30th June, 2005) and the Drugs and Cosmetics Rules, 1945 (As Amended Up to the 30th June, 2005)
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2005 Pages: 553
Publishers:	India Ministry of Health & Family Welfare
Related links:	http://pharmaceuticals.gov.in/
Countries:	India

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:	Effective Drug Regulation - A Multicountry Study and Annex 1: Guide for Data Collection to Assess Drug Regulatory Performance
Subjects:	Quality and Safety: Medicines > Regulatory Support
Author:	Ratanawijitrasin, Sauwakon; Wondemagegnehu, Eshetu
Year:	2002 Pages: 187
Publishers:	WHO Headquarters in Geneva

Title:	Effective Medicines Regulation: Ensuring Safety, Efficacy and Quality - WHO Policy Perspectives on Medicines, No. 007, November 2003 [French] [Spanish]
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2003 Pages: 6
Publishers:	WHO Headquarters in Geneva

Title:	Ensuring the Quality of Medicines in Resource-Limited Countries: An Operational Guide
Subjects:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy
Year:	2007 Pages: 207
Publishers:	United States Agency for International Development (USAID) United States Pharmacopeia (USP)
Regions:	Global

Title:	Essential Drugs and Registration of Pharmaceuticals: The Sri Lankan Experience
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	1993 Pages: 7
Publishers:	WHO Headquarters in Geneva
Countries:	Sri Lanka

Title:	Establishment of Statutory Drug Regulation in Developing Countries
Subjects:	Quality and Safety: Medicines > Regulatory Support
Author:	Fallet, Patrick
Year:	1983 Pages: 10
Publishers:	WHO Headquarters in Geneva
Regions:	Global

Title:	Eye on the Ball. Medicine Regulation – Not IP Enforcement – Can Best Deliver Quality Medicines
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2011 Pages: 51
Publishers:	Oxfam
Regions:	Global

Title:	FIP Statement of Policy on Counterfeit Medicines [French] [Spanish]
Subjects:	Medicine Information and Evidence for Policy > Medicines Policy Quality and Safety: Medicines > Counterfeit Medicines Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support
Year:	2003 Pages: 4
Publishers:	International Pharmaceutical Federation - FIP
Related links:	http://www.fip.org/statements
Regions:	Global

Title:	FIP Statement of Professional Standards - Code of Ethics for Pharmacist [French] [Spanish]
Subjects:	Medicine Information and Evidence for Policy > Medicines Policy Medicine Programme Coordination > Human Resources for Pharmaceutical Sector Quality and Safety: Medicines > Regulatory Support
Year:	2004 Pages: 2
Publishers:	International Pharmaceutical Federation - FIP
Related links:	http://www.fip.org/statements
Regions:	Global

Title:	First African Medicines Regulatory Authorities Conference - Final Report. Addis Ababa, Ethiopia, 31 October – 3 November 2005
Subjects:	Quality and Safety: Medicines > Regulatory Support
Year:	2009 Pages: 50
Publishers:	World Health Organization - Regional Office for Africa (WHO/AFRO)
Regions:	Africa (AFRO)


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Last updated: May 3, 2013