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Population: 7,270,000

Largest cities: Belgrade (capital), Novi Sad, Nis, Kragujevac

Approval Process

Serbia is not a European Union member and still has its own, specific legislation requirements.


  • realistic start-up time: 4.5 months
Recruitment Potential

During the last decade, the number of clinical trials in Balkan countries, including Serbia, significantly increased. Patients (mostly treatment-naïve) are willing to participate in clinical trials to have the possibility for treatment with novel therapies which are not yet available or not reimbursed by the Serbian healthcare system.

Estimated deaths per 100,000 population by cause (higher than world/European average):

Diseases Serbia World Average Europe Average
Cardiovascular Disease 881.9 240.9 465.2
Neoplasms 349.3 222.1 236.2
Respiratory Diseases 65.3 53.3 48.8
Digestive Diseases 59.6 32.0 30.9
Diabetes Mellitus 51.1 21.6 19.4
Genitourinary Diseases 38.3 18.8 20.1
Neurological Conditions 34.1 27.4 59.5
Mental and substance use disorders 7.1 4.3 11.1
Musculoskeletal diseases 2.8 2.1 2.8

Data from World Health Organization

The highest burden of disease in Serbia is due to:

  • cardiovascular disease (responsible for 55% of mortality) – a high prevalence of risk-factors such as tobacco smoking (33% of adult population over 20 smoke) and growing obesity among adults and children.
  • cancer (responsible for 20% of mortality)- the second biggest killer responsible for more than 20 000 deaths annually. The mortality for preventable cancer is of concern, especially for:
    • cervical cancer (incidence three times higher than the EU average),
    • breast cancer (incidence higher than the EU average)
    • and growing lung cancer especially among women
Investigators and Sites

There are 43 well equipped and experienced university hospitals in Serbia, including 17 ones located in Belgrade. Serbian investigators are familiar with ICH GCP, highly motivated and deliver high quality data within the required timelines.
The healthcare system in Serbia is centralized creating an important advantage for clinical trial recruitment due to high concentration of patients in large medical centers.