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

The regulatory process takes 60 days for phase I to III and 30 days for phase IV (period legally limited), and includes an ethical evaluation. A detailed listing of documents requested has been published. The applicant may be either the sponsor, its legal representative or the coordinating investigator, but the form must be filled in in Bulgarian. Any objection or request 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.

Customs clearance is not issued automatically with the approval but is granted upon request for each shipment separately.

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

Health care system

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.

Infrastructure

Highway access to major towns, no fast inter-city train system available (average speed 80 – 100 km/h), air traffic (both national and international) currently concentrated at the airports in Sofia, Burgas, Varna and Plovdiv.

Clinical Trials Management

Since its establishment in 1991, ECRON/Convex has conducted more than 135 Phase I-IV clinical trials. ECRON/Convex collaborates with all significant investigational units in Bulgaria, including local regulatory authorities, BDA and Ministry of Health. Good professional contacts have been created with the managing staff of the hospitals in Bulgaria, and with specialised laboratories, courier services, customs, etc. Bulgaria is joining the EU from 1 January 2007. At present a new Law on Drugs and Pharmacies in Human Medicine is being discussed in the Bulgarian Parliament that should be effective as of 1 January 2007.

Local office/staff

ECRON - Convex, 59 Vitosha Blvd., Sofia 1000, Bulgaria
Phone: +359 (0) 2 986 3109 Fax: +359 (0) 2 988 8700
Email: bd@ecronacunova.com

Links

Official EU enlargement pages
Authority: Bulgarian Drug Agency BDA
Drugs registered in BG
LECs authorised by MoH