The clinical trials in Bulgaria are strictly regulated based on international rules and norms.
Regional Health Inspectorate (RHI) under the authority of the Minister (Ministry of Health/MoH) is the competent certification authority for clinical sites. Based on their decision, an official document (Authorization for Medical Activities) is issued. This document sets out the approved activities that can be conducted in the clinical site, including clinical trials, scientific and educational projects.
Therefore, clinical trials are allowed only in medical facilities, certified by the MoH and its additional structure RHI.
To start a clinical trial central Ethics Committee (EC for clinical trials) and the BDA (Bulgarian Drug Agency) approvals are needed.
According to Bulgaria’s legislation (LMPHM and Regulation 31), submission of documents for
clinical trial approval of an investigational drug shall be made to the Bulgarian Drug Agency (BDA) and central Ethics Committee (EC for clinical trials).
The application documents can be submitted to BDA parallelly with submission to EC for clinical trials. Within 60 calendar days after the submission of all documents, EC gives a written approval or refusal of the clinical trial which is sent to the applicant and the BDA.
The time frame for BDA approval after submission of the study documents is also 60 days. The clinical trial may start if, within 60 days, the BDA has not issued a notification with reasons for disapproval of the clinical trial, but the BDA would usually issue an approval to start the trial.
In case of IMP of biological or genetical origin the BDA approval must be awaited, and the time frame is increased to 90 days.