» Local Environment» Bulgarian Healthcare System» Regulatory framework» Approval of clinical trials» Services» Regulatory affairs» Feasibility» Clinical monitoring» Project management» Drug handling» Other services» Advantages» Contacts


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


Home /  / Regulatory framework
 © 2013 All rights reserved
 Bulgaria, Sofia
design and hosting:  
MAKSOFT, Sofia © 2013