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James CzabanAnna Abram
Deborah AuterHoward Sklamberg
Challenges and Approaches forFDA-Regulated Companies Operating Globally
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The Sheer Number of International Regulatory Bodies and the Challenges of Collaboration and Partnerships
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• Algeria: Directorate of Pharmacy and Medicine
• Botswana: Ministry of Health
• Egypt: Egyptian Drug Authority
• Ghana: Food and Drugs Authority
• Kenya: Pharmacy & Poisons Board
• Morocco: Ministry of Health
• Namibia: Namibia Medicines Regulatory Council
• South Africa: Medicines Control Council
• Sudan: National Medicines and Poisons Board
• Tanzania Food and Drugs Authority
• Tunisia: Directorate of Pharmacy and Medicine
• Uganda: National Drug Authority
• Zimbabwe: Medicines Control Authority of Zimbabwe
Africa
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Regional & National Regulatory Authorities
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• ASIAN Harmonization Working Party (AHWP)
• Asia Pacific Economic Cooperation (APEC)
• Association of Southeast Asian Nations (ASEAN)
• Bangladesh: Directorate General of Drug Administration (DGDA)
• Brunei Darussalam: Ministry of Health
• China: China Food and Drug Administration
• Hong Kong: Drug Office, Department of Health
• India: Central Drugs Standard Control Organization (CDSCO)
• Indonesia: The National Agency of Drug and Food Control
• Republic of Korea: Ministry of Food and Drug Safety, Korea Food and Drug Administration
Asia - Pacific
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Regional & National Regulatory Authorities
• Malaysia: National Pharmaceutical Control Bureau
• Mongolia: Ministry of Health
• Nepal: Department of Drug Administration
• Philippines: Department of Health, Philippine Food and Drug Administration
• Singapore: Health Sciences Authority (HSA), Health Products Regulation Group (HPRG)
• Sri Lanka: Ministry of Health
• Taiwan Food and Drug Administration (TDFA)
• Thailand: Food and Drug Administration
• Vietnam: Drug Administration of Vietnam
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• Australia New Zealand Therapeutic Product Agency (ANZTPA)
• Australia: Therapeutic Goods Administration (TGA)
• Australian Department of Health: Expert Review of Medicines and Medical Devices Regulation
Australia
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Regional & National Regulatory Authorities
New Zealand• New Zealand: Medicines and Medical Devices Safety Authority
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• European Medicines Agency (EMA)
• European Heads of Medicines Agencies
• European Directorate for the Quality of Medicines& Healthcare
• European Commission: Medicinal products for human use
• Armenia: Scientific Centre of drug and medical technology expertise
• Austria: Austrian Agency for Health and Food Safety
• Azerbaijan: Azerbaijan Ministry of Health
• Belarus: Center for Examinations and Tests in Health Service
• Belgium: Federal Agency for Medicines and Health Products (FAMHP)
• Bulgaria: Bulgarian Drug Agency
• Croatia: Agency for Medicinal Products and Medical Devices of Croatia
• Czech Republic - State Institute for Drug Control
• Denmark: Danish Medicines Authority
• Estonia - State Agency of Medicines
• Finland - Finnish Medicines Agency
Europe
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Regional & National Regulatory Authorities
• France - French National Agency for the Safety of Medicine Health Products (ANSM)
• Germany: Federal Institute for Drugs and Medical Devices (BfArM)
• Greece: National Organization for Medicines
• Hungary: National Institute of Pharmacy and Nutrition
• Iceland: Icelandic Medicines Agency
• Ireland: Health Products Regulatory Authority (HPRA)
• Italy: Italian Medicines Agency
• Kazakhstan: National Center for Drug Expertise, Medical Devices and Medical Equipment
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• Latvia: State Agency of Medicines
• Liechtenstein: Office of Health/Department of Pharmaceuticals
• Lithuania: State Medicines Control Agency
• Luxembourg: Ministry of Health
• Malta: Medicines Authority
• Netherlands: Healthcare Inspectorate
• Netherlands: Medicines Evaluation Board
• Norway - The Norwegian Medicines Agency
• Poland: Chief Pharmaceutical Inspectorate
• Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Portugal: National Authority of Medicines and Health Products, IP (INFARMED)
• Romania: National Agency for Medicines Agency
• Russian Federation: Ministry of Public Health
• Slovakia: State Institute for Drug Control (SIDC)
Europe
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Regional & National Regulatory Authorities
• Slovenia: Agency for Medicinal Products and Medical Devices (ARSZMP)
• Spain: Spanish Agency of Medicines and Medical Devices (AEMPS)
• Sweden: Medical Products Agency (MPA)
• Tajikistan: Ministry of Health of the Republic of Tajikistan
• United Kingdom: Medicines and Healthcare Products Regulatory Agency (MHRA)
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• Mercado Comun del Sur (MERCOSUR)
• Pan American Health Organization
• Pan American Network for Drug Regulatory Harmonization (PANDRH)
• Canada: Health Canada
• Mexico: Federal Commission for the Protection against Sanitary Risk (COFEPRIS)
• United States: Food and Drug Administration (FDA)
North America
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Regional & National Regulatory Authorities
• Argentina: National Administration of Drugs, Food & Medical Technology
• Brazil: Health Surveillance Agency (ANVISA)
• Chile: Ministry of Health
• Colombia: National Institute of Food and Drug Monitoring (INVIMA)
• Costa Rica: Ministry of Health
• Cuba: Center for State Control of Drugs, Medical Devices
• Dominican Republic: Directorate General of Drugs and Pharmacies
• Honduras: Directorate General of Health Regulation
• Panama: Ministry of Health
• Peru: Ministry of Health
• Uruguay: Ministerio de Salud
• Venezuela: National Institute of Hygiene
Central and South America
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• Jordan: Jordan Food and Drug Administration
• Israel: Ministry of Health
• Saudi Arabia: Saudi Food and Drug Authority
• United Arab Emirates: Ministry of Health
• Yemen: Supreme Commission for Drugs and Medical Appliances
Middle East
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Regional & National Regulatory Authorities
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• ANDEAN Community
• International Coalition of Medicines Regulatory Authorities
• International Conference on Harmonisation (ICH)
• IPEC Federation
• International Generic Drug Regulators Programme
• International Medical Device Regulators Forum
• International Organization for Standardization (ISO)
• International Pharmaceutical Regulators Forum (IPRF)
• Organisation for Economic Co-operation and Development (OECD): Good Laboratory Practice (GLP)
• Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)
• United Nations - Global Health
• World Health Organization (WHO)
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International Regulatory, Standards, and Harmonization Organizations
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Brief Remarks by Anna Abram
Deputy Commissioner for Policy, Legislation, and International Affairs, Office of the Commissioner
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Today’s Q & A Roadmap
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Theme 1: COMPLIANCE
Theme 2: INNOVATION
Theme 3: EMERGING MARKETS
Topic A:
Global Regulatory Partnerships and Collaboration
Topic B:
Practical Advice for Global Businesses
Topic C:
Trends to Watch
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Theme 1: COMPLIANCE
Topic A:
Global Regulatory Partnerships and Collaboration
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Theme 2: INNOVATION
Topic A:
Global Regulatory Partnerships and Collaboration
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Theme 3: EMERGING MARKETS
Topic A:
Global Regulatory Partnerships and Collaboration
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Theme 1: COMPLIANCE
Topic B:
Practical Advice for Global Businesses
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Theme 2: INNOVATION
Topic B:
Practical Advice for Global Businesses
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Theme 3: EMERGING MARKETS
Topic B:
Practical Advice for Global Businesses
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Theme 1: COMPLIANCE
Topic C:
Trends to Watch
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Theme 2: INNOVATION
Topic C:
Trends to Watch
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Theme 3: EMERGING MARKETS
Topic C:
Trends to Watch
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Theme 1: COMPLIANCE
Theme 2: INNOVATION
Theme 3: EMERGING MARKETS
Topic A:
Global Regulatory Partnerships and Collaboration
Topic B:
Practical Advice for Global Businesses
Topic C:
Trends to Watch
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Thank you
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