Serbia

Regulatory

In the Republic of Serbia, clinical trials are regulated nationally by the Medicines and Medical Devices Agency of Serbia (ALIMS) in accordance with the Law on Medicines and Medical Devices and relevant rulebooks. While Serbia is not an EU Member State and thus does not directly utilize the Clinical Trials Information System (CTIS) portal, national regulations are heavily harmonized with EU guidelines and Good Clinical Practice (ICH/GCP) standards.

The authorization process requires dual approval:

• ALIMS Authorization: Operational and scientific review of the documentation dossier (protocol, Investigator’s Brochure, IMPD/GMP evidence, and labeling). Foreign sponsors without a seat in Serbia must appoint a local legal representative to submit the dossier and interface with ALIMS via the official RIMS portal.
• Ethics Committee Review: Approval from the Ethics Committee of Serbia (and relevant institutional ethics committees).

ALIMS issues a decision within a maximum statutory timeline of 60 days from the receipt of a complete application. Substantial amendments are evaluated within 30 days. Ongoing study tracking, safety updates, and quarterly progress reports are submitted directly to ALIMS.

Official Links

https://www.alims.gov.rs

Pharmaceutical Industry & Clinical Trials Market

Serbia represents a major clinical trial hub in the Central and Eastern Europe (CEE) region. The country consistently attracts international pharmaceutical investment due to its strong clinical infrastructure, quick patient recruitment, and cost efficiency.

Key operational and market highlights include:

• Trial Capacity: Over 100–150 new clinical trials are approved annually, engaging thousands of patients across specialized tertiary care centers.
• Trial Focus: Phase III and Phase IV trials dominate the landscape, with significant concentration in oncology, central nervous system (CNS) disorders, cardiovascular diseases, and metabolic conditions.
• Cost Efficiency: Competitive site fees, lower operational expenses, and favorable economic conditions drastically minimize overall trial execution costs compared to Western Europe.
• Data Integrity: High compliance with ICH/GCP standards makes Serbian trial data widely accepted by the EMA and FDA.

Key Opportunities

• Highly Qualified Investigators: Well-trained medical professionals and academic key opinion leaders (KOLs) across university hospital centers (e.g., Belgrade, Novi Sad, Niš, Kragujevac).
• Centralized Patient Base: High concentration of treatment-naive patients in urban clinical centers enables rapid site activation and recruitment.
• EU Regulatory Alignment: Local regulatory processes mirror European standards, facilitating smooth transition of study data into international marketing authorization applications.

Medical System in Serbia

Healthcare expenditure in Serbia accounts for approximately 8.5% to 9% of national GDP, financed through a combination of mandatory public insurance and private out-of-pocket spending:

• Public Financing: The primary healthcare funding mechanism is the National Health Insurance Fund (RFZO / Republički fond za zdravstveno osiguranje), which covers essential medical services, hospitalizations, and prescription drugs on the national Positive List.
• Healthcare Infrastructure: Healthcare is organized across primary care centers (Dom zdravlja), regional secondary hospitals, and major tertiary university clinical centers (such as the University Clinical Centre of Serbia in Belgrade).
• Private Sector Growth: The private healthcare sector has expanded rapidly, providing supplementary services, specialized diagnostic capabilities, and outpatient care to complement the public system.