Included are some links we hope will serve as references and resources. We recommend that you keep checking back for up-to-the minute regulatory and international news in the bio- and pharmaceutical sectors.

Regulatory Authorities in Europe

European Agency Medicines (EMA)

Heads of Medicines Agencies (HMA)

European Commission Public Health Website

DG Enterprises – Pharmaceuticals – Regulatory Framework and Market Authorisations

European National Authorities

Austria: Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH

Belgium: Federal Public Service – Health, Food chain safety and Environment

Bulgaria: Bulgarian Drug Agency (BDA)

Cyprus: Ministry of Health

Czech Republic: State Institute for Drug Control (SÙKL)

Denmark: Lægemiddelstyrelsen (DKMA)

Estonia: State Agency of Medicines

Finland: Finnish Medicines Agency

France: Agence Nationale de Sécurité du Medicaments et des produits de santé (ANSM)

Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

Greece: National Organization for Medicines

Hungary: National Institute of Pharmacy

Iceland: Icelandic Medicines Control Agency (IMCA)

Ireland: Health Products Regulatory Authority (HPRA)

Italy: Agenzia Italiana del Farmaco (AIFA)

Latvia: State Agency of Medicines

Lithuania: State Medicines Control Agency

Luxembourg: Ministère de la Santé

Malta: Medicines Authority

Netherlands: College ter Beoordeling van Geneesmiddelen

Norway: Norwegian Medicines Agency (Statens Legemiddelverk)

Poland: The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Portugal: National Medicines and Health Products Authority (INFARMED)

Romania: National Agency of Medicines and Medical Devices (ANM)

Slovak Republic: State Institute for Drug Control (SIDC)

Slovenia: Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (JAZMP)

Spain: Agencia Española de Medicamentos y Productos Sanitarios

United Kingdom: Medicines and Healthcare Products Regulatory Agency (MHRA)

Sweden: The Medical Products Agency

Switerland: Swiss Agency for Therapeutic Products

Regulatory Authorities in The Americas

North America

Canada: Health Canada – Health Products and Food Branch

Mexico: Ministry of Health

USA: Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER)

Central & South America

Argentina: National Administration of Drugs, Foods and Medical Technology

Bolivia: Health Ministry

Brazil: Ministry of Health

Chile: Health Ministry

Colombia: Health Ministry and Social Protection

Costa Rica: Health Ministry

Ecuador: Ministry of Public Health

Guatemala: Ministry of Public Health

Panama: Health Ministry

Paraguay: Ministry of Public Health

Peru: Ministry of Health

Uruguay: Ministry of Public Health

Venezuela: Ministry of Health and Social Development

Regulatory Authorities in Asia

India: Ministry of Health & Family Welfare

Indonesia: Ministry of Health

Israel: Ministry of Health

Japan: Ministry of Health, Labour and Welfare

Jordan: Ministry of Health

Korea: Ministry of Food and Drug Safety

Lebanon: Ministry of Public Health

Malaysia: National Pharmaceutical Control Bureau

Philippines: Department of Health

Singapore: Ministry of Health

Taiwan: Ministry of Health and Welfare

Thailand: Food and Drug Administration

United Arab Emirates: Ministry of Health

Regulatory Authorities in Oceania

Australia: Australian Government Department of Health and Ageing

New Zealand: Medicines and Medical Devices Safety Authority

Regulatory Authorities in Africa

Algeria: Ministry of Public Health

Egypt: Ministry of Health

Ethiopia: Ministry of Health

Ghana: Ministry of Health

Liberia: Ministry Health & Social

Morocco: Ministry of Public Health

Nigeria: Federal Ministry of Health

République Démocratique du Congo: Ministry of Public Health

Rwanda: Ministry of Health

South Africa: Department of Health

South Sudan: Ministry of Health

Tanzania: Ministry of Health and Social Welfare

Uganda: Ministry of Health

Zambia: Ministry of Health

Zimbabwe: Ministry of Health and Child Welfare


World Health Organization (WHO)

Pan American Health Organization (PAHO)

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

International Federation of Pharmaceutical Manufacturers and Associates (IFPM)

Drug Information Association (DIA)

Pharmaceutical Information & Pharmacovigilance Association

The Organisation for Professionals in Regulatory Affairs (TOPRA)


Association of the European Self-Medication Industry (AESGP)

BioIndustry Association (BIA)

Drug3k – Online Drug Encyclopedia


European Pharmacopoeia

European Federation of Pharmaceutical Industries and Associations (EFPIA)

European Directorate for the Quality of Medicines and Healthcare (EDQM)

European Generic Medicines Association (EGA)

European Pharmaceutical Legislation

CPVS’s mission is to combine the strength of our expertise and experience to advance the success of drug development and product life cycle management.