Hungary is one of the largest countries in Eastern Europe to meet all EU norms and standards since joining the European Union. Since 2004, the legislation has been fully compliant with all quality requirements according to European standards. The approval process is not difficult and depends on the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI). OGYÉI in Hungary is responsible for requirements such as production control, registration and pharmacovigilance. The approval period is identical to European standards: within 60 days, the Regulatory Authority (RA) and the Central Ethics Committee (CEC) grant approval to start a clinical trial. Local Ethics Committees (LECs) monitor the progress of ethnic trials locally.
Hungary is currently one of the leading countries in the field of clinical trials. Hungary has an organised infrastructure that is particularly innovative and precise.Today, Hungary ranks 4th in the EU and 10th in the world in terms of accessibility and availability per capita.The pharmaceutical sector in Hungary is one of the flagships of the economy, accounting for 7.5% of the national GDP.
Hungary, with a population of 9.77 million, has a relatively high success rate in clinical trials. Approximately 350 clinical trials are conducted in Hungary each year, and 20,000 patients participate in clinical trials each year. The medical system in Hungary is centralised through a single healthcare system managed by the National Health Insurance Fund of Hungary (Nemzeti Egészségbiztosítási Alapkezelő (NEAK)).