All approvals by the Local Ethics Committees (LECs) in charge of the
trial sites must be obtained prior to the regulatory submission. In
LECís 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 hospitalsí 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
provided in Bulgaria
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.
Clinical trial authorisation and EC opinion, feasibility survey, site
selection and set-up, on-site monitoring, national project
phase-I trials in own unit with 12 beds located at a hospital