International Regulatory Links

The main prerequisite to work under cGMP is the right knowledge and understanding of the actual pharmaceutical regulations related to the specific sales market. This page summarizes the relevant links to regulatory agencies.


USA   Food and Drug Association (FDA)
Europe   European Union Drug Regulatory Agency (Eudra)
    Heads of Agencies for the European Union
UK   Medicines and Healthcare products Regulatory Agency (MHRA)
Germany   BfArM
Portugal   Instituto Nacional da Farmácia e do Medicamento
France   French Health Products Safety Agency
Spain   Agencia Española del Medicamento
Norway   Norway Medicines Board
Sweden   Medical Products Agency
Finland   National Agency for Medicines
Italy   Ministero della Salute
Netherlands   CBG
Australia   Therapeutic Goods Administration (TGA)
Bulgaria   Bulgarian Drug Agency

Therapeutic Products Directorate (TPD)

Chile   Chile Regulatory Agency
Russia   Czech Republic
Denmark   The Danish Medicines Agency
Estonia   State Agency of Medicines
Greece   EOD
Hong Kong   Hong Kong Department of Health Welfare and Food
India   Ministry of health and family welfare
Ireland   Irish Medicine Board
Japan   Ministry of Health, Labour and Welfare (MHLW)
Russia   Ministry of Health of the Russian Federation
Switzerland   Swiss Medic
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