PHARMALLIANCE LINKS WORLDWIDE PHARMACEUTICAL REGULATORY AUTHORITIES

USEFUL LINKS

PharmAlliance is committed to supporting the business development of the pharmaceutical and related industries by providing complete and comprehensive expertise for achieving global market presence

Here are some links to essential information for achieving global market presence…

DISCLAIMER:
We have taken a lot of care in compiling these links. They are included here solely for convenience of access to information that we believe to be useful to our visitors. We have no control over any of these links or websites. Due to the dynamic nature of the internet, we cannot be held responsible for the accuracy of the information given here, and/or for the contents of the websites referred to.

INTERNATIONAL :

	International Conference on Harmonization (ICH): ICH Home Page ICH Guidelines - Quality, Safety, Efficacy, Multidisciplinary, including Common Technical Document (CTD) and Electronic Common Technical Document: (eCTD) World Health Organization (WHO): WHO: Home Page WHO: Medicines (Medicines Policy and Standards…) WHO: Medicines: Quality Assurance - Links to WHO Guidelines, including WHO GMP WHO: Certification Scheme for the Quality of Pharmaceuticals WHO: Prequalification Programme World Trade Organization (WTO): WTO: Home Page WTO: TRIPS Gateway (Trade-Related Aspects of Intellectual Property Rights) World Intellectual Property Organization (WIPO): WIPO: Home Page WIPO: Patent Search Free Patents Online: Free Patent Search, Free Patent PDF Downloads, Free Intellectual Property Alerts

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UNITED STATES OF AMERICA (USA) :

	United States Food and Drug Administration (US FDA): US FDA: Home Page US FDA: Center for Drug Evaluation and Research (CDER) US FDA: CDER Guidance Documents US FDA: Center for Biologics Evaluation and Research (CBER) US FDA: CBER Guidance Documents US FDA: Abbreviated New Drug Application (ANDA) Process for Generic Drugs US FDA: Current Good Manufacturing Practices (cGMP) Regulations (21 CFR Parts 210 and 211) US FDA: Drug Master Files (DMF guidance and DMF Database) US FDA: Center for Devices and Radiological Health (CDRH) US FDA: CDRH Regulatory and Marketing Advice for Medical Devices

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AMERICAS :

	CANADA: Health Canada: Home Page (in English and French) Health Canada: Health Products and Food Branch Health Canada: Legislation and Guidelines – Drugs and Health Products – Main Page Health Canada: Therapeutic Products Directorate LATIN AMERICA: Argentina: Ministry of Health (in Spanish) Argentina: National Administration of Drugs, Foods and Medical Technology (in Spanish) Bolivia: Ministry of Health and Social Welfare (in Spanish) Chile: Health Ministry (in Spanish) Chile: Institute of Public Health (in Spanish) Colombia: Ministry of Health (in Spanish) Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos (in Spanish) Ecuador: Ministry of Public Health (in Spanish) El Salvador: Ministry of Public Health and Social Assistance (in Spanish) Guatemala: Ministry of Health (in Spanish) Guyana: Ministry of Health Guyana: National Bureau of Standards Jamaica: Ministry of Health Mexico: Ministry of Health (in Spanish) Mexico: Federal Commission for Protection against Health Risks (in Spanish) Nicaragua: Ministry of Health (in Spanish) Panama: Ministry of Health (in Spanish) Peru: Ministry of Health (in Spanish) Peru: General Directorate of Pharmaceuticals, Devices and Drugs (in Spanish) Trinidad and Tobago: Ministry of Health Trinidad & Tobago: Bureau of Standards Uruguay: Ministry of Public Health (in Spanish)

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EUROPEAN UNION (EU) :

European Medicines Agency (EMEA):
EMEA : Home Page

EudraLex : The Rules Governing Medicinal Products in the European Union
(including Notice to Applicants, Good Manufacturing Practices,
and other Guidelines for Human and Veterinary Medicinal Products)

European Directorate for the Quality of Medicines and Healthcare (EDQM):
EDQM: Home Page
EDQM: Certification of Pharmaceutical Substances – News and General Information
on APIs and Excipients, Certificate of Suitability (CEP) Database

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EUROPEAN NATIONAL AUTHORITIES :

	GERMANY: Germany: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices (BfARM) Germany: Robert Koch Institute (in German) Germany: Paul Ehrlich Institute (in German) Germany: Federal Institute for Risk Assessment UNITED KINGDOM: UK: Department of Health UK: Health Protection Agency UK: Medicines and Healthcare products Regulatory Agency UK: National Institute for Biological Standards and Control UK: Veterinary Medicines Directorate FRANCE: France: Ministry of Health (in French) France: Sanitary Safety of Health Products Agency - AFSSAPS (in French) France: National Agency for Veterinary Medicinal Products ITALY: Italy: Ministry of Health (in Italian) Italy: National Institute of Health SPAIN: Spain: Ministry of Health and Consumption Spain: Spanish Agency of Medicinal Products SWITZERLAND: Switzerland: Federal Office of Public Health Switzerland: Agency for Therapeutic Products (SWISSMEDIC) Switzerland: Federal Veterinary Office OTHER EUROPEAN NATIONAL AUTHORITIES: Austria: Federal Ministry of Labour, Health and Social Affairs (in German) Belgium: Ministry of Social Affairs, Public Health and the Environment Belgium: Pharmaceutical Inspectorate Bulgaria: Ministry of Health (in Bulgarian) Bulgaria: Drug Agency Croatia: Ministry of Health Czech Republic: Ministry of Health (in Czech) Czech Republic: State Institute for Drug Control Denmark: Ministry of Health Denmark: Medicines Agency Denmark: Veterinary and Food Administration Estonia: Ministry of Social Affairs Estonia: State Agency of Medicines Finland: Ministry of Social Affairs and Health Finland: National Agency for Medicines Greece: Ministry of Health and Welfare (in Greek) Greece: National Organization for Medicines Hungary: Ministry of Health Hungary: National Institute of Pharmacy Iceland: Ministry of Health and Social Security Iceland: Medicines Control Agency Ireland: Department of Health and Children Ireland: Medicines Board Latvia: State Agency of Medicines Lithuania: State Medicines Control Agency Luxembourg: Ministry of Health (in French) Malta: Ministry of Health Netherlands: Ministry of Health, Welfare and Sport Netherlands: Medicines Evaluation Board Norway: Ministry of Health and Care Services Norway: Norwegian Medicines Agency (in Norwegian and English) Poland: Ministry of Health and Social Security (in Polish) Poland: National Medicines Institute Portugal: Ministry of Health (in Portuguese) Portugal: National Institute of Pharmacy and Medicines (in Portuguese and English) Romania: Ministry of Health and the Family (in Romanian) San Marino: Ministry of Health and Social Security (in Italian) Slovak Republic: Ministry of Health (in Slovak and English) Slovak Republic: State Institute for Drug Control Slovak Republic: State Veterinary and Food Administration (in Slovak) Slovenia: Ministry of Health Sweden: Medical Products Agency (in Swedish and English) Turkey: Ministry of Health (in Turkish and English) Ukraine: Ministry of Health (in Ukrainian, English and Russian)

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BRAZIL, RUSSIA, INDIA AND CHINA (BRIC) :

	BRAZIL: Brazil: Ministry of Health (in Portuguese) Brazil: National Health Surveillance Agency (ANVISA) Brazil: Oswaldo Cruz Foundation RUSSIAN FEDERATION: Russian Federation: Mednet (in Russian) Russian Federation: Ministry of Health and Social Development (in Russian) INDIA: India: Ministry of Health and Family Welfare India: Central Drug Standards Control Organisation (CDSCO) India: Drugs & Cosmetic Act & Rules (PDF, 8.76 MB) India: Notifications of Amendments to the Drugs & Cosmetic Act & Rules India: Good Manufacturing Practices – Schedule M (PDF, 280 KB) India: Good Clinical Practice Regulation – Schedule Y India: Guidelines for Import and Manufacture of Medical Devices India: List of State Drugs Control Organizations CHINA: China: General Administration of Quality Supervision, Inspection and Quarantine China: Ministry of Health (in Chinese) China: State Food and Drug Administration (SFDA) China: National Institute for the Control of Pharmaceutical and Biological Products (in Chinese)

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ASIA – PACIFIC :

	JAPAN: Japan: Ministry of Health, Labour and Welfare (MHLW) Japan: Pharmaceuticals and Medical Devices Agency (PMDA) AUSTRALIA AND NEW ZEALAND: Australia New Zealand Therapeutic Products Authority (ANZTPA) (This project is on hold for now, but the site has a lot of useful information) Australia: Department of Health Australia: Therapeutic Goods Administration (TGA) Australia: Pesticides & Veterinary Medicines Authority (APVMA) New Zealand: Ministry of Health New Zealand: Medicines and Medical Devices Safety Authority (MEDSAFE) OTHER ASIA-PACIFIC NATIONAL AUTHORITIES: Bangladesh:Ministry of Health And Family Welfare Brunei: Ministry of Health Fiji: Ministry of Health Hong Kong: Department of Health Indonesia: Ministry of Health Korea: Food and Drug Administration (KFDA) Malaysia: Ministry of Health Malaysia: National Pharmaceutical Control Bureau Nepal: Ministry of Health and Population Nepal: Department of Drug Administration Pakistan: Ministry of Health Portal Pakistan: Drugs Control Organization Papua New Guinea: Department of Health Philippines: Department of Health Singapore: Ministry of Health Singapore: Health Sciences Authority Singapore: Agri-food and Veterinary Authority Sri Lanka: Ministry of Health Taiwan: Department of Health Taiwan: National Laboratories of Foods and Drugs Thailand: Ministry of Public Health (in Thai) Thailand: Food and Drug Administration Vietnam: Ministry of Health

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MIDDLE EAST :

	Bahrain: Ministry of Health Israel: Ministry of Health Israel: Ministry of Health – Pharmaceutical Administration Jordan: Ministry of Health Lebanon: Ministry of Public Health Palestinian Authority: Ministry of Health Saudi Arabia: Ministry of Health United Arab Emirates: Ministry of Health (New site, not yet fully functional) United Arab Emirates: Federal Department of Medicines and Pharmacy Control (New site, not yet functional) United Arab Emirates: Ministry of Health – Old site, still functional United Arab Emirates: Federal Department of Medicines and Pharmacy Control – Old site, still functional

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AFRICA :

	REPUBLIC OF SOUTH AFRICA: South Africa: Department of Health South Africa: Medicines Control Council (MCC) - Links to all Guidelines for Licensing, Registration, GMP, etc), are listed under “Documents” on this page. OTHER AFRICAN NATIONAL AUTHORITIES: Botswana: Ministry of Health Ghana: Ministry of Health Kenya: Ministry of Health Maldives: Ministry of Health Mauritius: Ministry of Health & Quality of Life Morocco: Ministry of Public Health (in French) Namibia: Ministry of Health and Social Services Senegal: Ministry of Health, Hygiene and Prevention (in French) Swaziland: Ministry of Health and Social Welfare Tanzania: Ministry of Health Tunisia: Ministry of Public Health (in French) Tunisia: Office of Pharmacy and Medicines (in French and Arabic) Uganda: Ministry of Health