Clinical Research in Bulgaria
Bulgaria is a country with a diverse culture and an ancient history dating back to prehistoric times. Even though Bulgaria has recenlty joined the EU, it is still a country relatively unknown to the rest of the World.
Although the Bulgarian pharmaceutical market is one of the smallest in the EU, over the last 10 years this market has grown at 7-10 percent annually. Seven of the United State’s largest pharmaceutical companies have been in the Bulgarian market for over 15 years.
Among the strenghts of Bulgaria are the traditions in pharmaceutical research and drug production, good medical research base, highly qualified and motivated researchers. As a recent EU member, Bulgaria upgrades it's legislation and procedures to be 100% compliant with European standards and norms. Most of the documents will be accepted in English, however any documents supplied to the patients will have to be translated. The country has a single national ethics committee, the Ethics Committee for Multicentre Trials, which is able to provide all necessary approvals for multicenter studies (for single centre studies the local Ethics committee has the authority to approve the study).
According to Bulgarian Association for Clinical Research (BACR), Bulgaria holds 1% of the world market turnover for clinical research (which is place 20 in the world). Among the therapeutic areas, Rheumatology had the highest number of trials, but in recent years Oncologhy has taken the lead.
Key local authority: Bulgarian Drug Agency
Image credit: "Orlov Most junction" by Boby Dimitrov from Sofia, Bulgaria, under CC-BY-SA-2.0.