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.

The legislation for clinical studies consists of chapter 4 of the Law for medicines and pharmacies in the human medicine and Regulation 14 for the conducting of clinical trials. You can find these documents o n the site of the Bulgarian Drug Agency. The current Bulgarian regulatory framework o n clinical studies covers most of the requirements of the EU directive. Further development of the legislation for clinical studies in order to reflect all aspects of the EU directive is expected by the end of 2005.

Bulgarian Drug Agency

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

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.

The legislation for clinical studies consists of chapter 4 of the Law for medicines and pharmacies in the human medicine and Regulation 14 for the conducting of clinical trials. You can find these documents o n the site of the Bulgarian Drug Agency. The current Bulgarian regulatory framework o n clinical studies covers most of the requirements of the EU directive. Further development of the legislation for clinical studies in order to reflect all aspects of the EU directive is expected by the end of 2005.

Bulgarian Drug Agency

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