Serbia's pharmaceutical market was valued at approximately €800 million-€1 billion in 2018, with a compulsory health insurance system as the primary payer and a notable domestic pharmaceutical manufacturing sector.
Hemofarm (a Stada subsidiary), Galenika, and Zdravlje are Serbia's main domestic pharmaceutical manufacturers, with Serbia also hosting manufacturing operations for contract production serving European and regional markets.
Regulatory authority: ALIMS (Medicines and Medical Devices Agency of Serbia) oversees drug approvals and market authorisation, with Serbia's regulatory framework aligned with EMA standards as part of its EU accession process.
Serbia has a long tradition of pharmaceutical manufacturing dating back to the Yugoslav era, with Hemofarm in Vršac representing one of the region's most significant pharmaceutical production sites and a major exporter to European and emerging markets.
As an EU candidate country, Serbia's pharmaceutical regulatory alignment with EMA standards is progressing, creating both opportunities for market integration and challenges in managing the transition from legacy regulatory frameworks.
