All approvals by the Local Ethics Committees (LECs) in charge of the trial sites must be obtained prior to the regulatory submission. In Bulgaria, the LEC’s approval process is limited by law to one month.

The regulatory process by the Bulgarian Drug Agency BDA takes 60 days for clinical trials of phases I to III and 30 days for phase IV (period legally limited), and includes an ethical evaluation. The applicant may be either the sponsor, its legal representative or the principal investigator but the form must be filled in in Bulgarian language. Any objection or requests for more information may prolong the approval process.

An international standard patient insurance is acknowledged but an additional insurance protecting investigators against patients' claims must be concluded.


Overall approval time is up to 90 days for phases I to III, 60 days for phase IV.

Private physicians provide basic care only and refer patients to hospitals’ outpatient departments or specialists. Clinical trials are permitted to be performed only at hospitals authorised by the state authorities, not at private doctors' offices. Therefore, a large patient pool of a specific indication can be found centralised in hospitals, some of them in charge of a population of several hundred thousand.

Highway access to major towns, no fast inter-city train system available, air traffic (both national and international) currently concentrated at the airports in Sofia, Burgas, Varna and Plovdiv.

CONVEX, 59 Vitosha Blvd., Sofia 1000, Bulgaria
Phone: +359 (0) 2 986 3109 Fax: +359 (0) 2 988 8700
Email: bulgaria@phamos.cz
Web site: www.convex.bg

Clinical trial authorisation and EC opinion, feasibility survey, site selection and set-up, on-site monitoring, national project management, phase-I trials in own unit with 12 beds located at a hospital

Authority: Bulgarian Drug Agency BDA
Drugs registered in BG: pages currently unavailable