So far no clinical gene therapy trials have been conducted in Estonia. The competent authority involved is the Ministry of Environment (Nature Protection Department or the Labor Inspection). The clinical trials are regulated by the Medicinal Products Act. Authorization for the conduct of a clinical trial of a medicinal product is granted by the State Agency of Medicines (SAM). The SAM is the National Drug Regulatory Authority for Human and Veterinary Products and Competent Authority for Medical Devices in Estonia. SAM has the following obligations: marketing authorization and quality control of medicinal products including biological products, evaluation and approval of applications for clinical trials, import and export authorization of medicinal products, control of licit use of psychotropic and narcotic substances, control over precursors, drug information, advertising and promotion control and pharmaceutical inspection.

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