Bulgaria

About

CRO in Bulgaria, cultural insight, market overview, medical system, and more

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average annual number of clinical trials

enrolled patients per year

potential clinical trial sites

GCT in Bulgaria

Country manager

Samer Hilan

Office information

Tel: +359 2 983 5358

Fax: +359 2 998 3005

Email: bd@gctrials.com

104 b. Ivan Geshov blvd., apt. 2, 1612 Sofia, Bulgaria

Country manager

Samer Hilan

Office information

Tel: +359 2 983 5358

Fax: +359 2 998 3005

Email: bd@gctrials.com

104 b. Ivan Geshov blvd., apt. 2, 1612 Sofia, Bulgaria

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Regulatory

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.

Official links

https://www.bda.bg/en/

Pharmaceutical Industry & Clinical Trials Market

Bulgaria offers great potential for Sponsors. It ranks top 20 in the world in terms of the number clinical trials performed and the Bulgarian market is valued at USD 330 Million.

Clinical research is one of the main areas of investment from research-based pharmaceutical companies into Bulgaria and despite only holding 7.5 million inhabitants, the country is positioning itself as a clinical trials hub for the entire CEE region. The clinical trials sector brings to the Bulgarian economy BGN 151.5 million per annum in the form of direct costs such as salaries, sites and investigators remuneration, statutory fees and other.

Around 200 new studies are launched annually in the country with an average of about 12,000 patients per year enrolled in such programs. Moreover, Bulgaria focuses on advanced-stage clinical research, with phase III and phase IV trials dominating the landscape.

Concerning the key opportunities Bulgaria offers as a clinical research hub, a number of positive aspects that should be noted:

the high number of highly educated professionals with university degrees, postgraduates, Masters and PhDs
the labor costs and the taxation framework are quite attractive versus any other country in the region – which drastically minimizes the costs of running clinical trials
Bulgaria is within the EU and therefore the regulation is homogenized with EU standards
the patient recruitment and the operational rhythm are quite efficient, which significantly reduces the timelines.

Medical System in Bulgaria

The Bulgarian healthcare budget is approximately 4.3% of the Bulgarian GDP. Despite low spending levels, healthcare sector in Bulgaria have been progressively improving. Life expectancy has been steadily increasing throughout the past four decades. Healthcare is financed by both public and private sources. In order to generate funds, country employs a mixed-finance system. While the government covers some share of healthcare costs, private sources finance many procedures. As a result, 57.8% of total health expenditures are from public finances and 42.2% are from the private sources.