Bulgaria

Regulatory

Under Regulation (EU) No 536/2014, clinical trials in the EU are authorized through the Clinical Trials Information System (CTIS). A sponsor submits one harmonized application via the EU-portal for all intended Member States. The dossier is split into:

• Part I (scientific and technical documentation, common to all CMS)
• Part II (national documents, including ethics requirements)

One Reporting Member State (RMS) coordinates the scientific review, which must be completed within 45 days, with parallel national (Part II) reviews. Requests for information may pause the clock. Each Member State must then issue a decision within 5 days, leading to an overall maximum of 60 days (extensions possible for complex therapies).

The CTR harmonizes approvals across the EU, integrates ethics committees into the process, and ensures transparency through the EU trial database. Since 31 January 2023, all new trials in the EU must follow this system.

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.