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Bulgaria, Sofia

Regulatory framework

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