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Bulgarian Healthcare System

There is a wide network of big university and regional hospitals with all facilities for management of medical diseases at a modern and highly qualified level. Our study sites are usually based at these institutions. There is also a network of specialized hospitals for Psychiatry, Neurology, Oncology, Heart Diseases and Pediatrics. The health insurance system is stable and covers all the citizens of the country. Clinical studies under ICH-GCP have been performed in Bulgaria for the last 10 years.  Over 160 clinical trials were approved for conducting in Bulgaria in 2004. Most of them are international multicentre studies sponsored by differnt pharmaceutical companies.

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Regulatory framework

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Approval of clinical trials

The approval of clinical studies in Bulgaria is a consecutive process in 2 steps:

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