Hungary

Regulatory

Hungary is a sea-locked country located in Central Europe with a population of 9.77 million (World Bank, 2019). Its biggest city and a capital is Budapest, with a population of 1.75 million.

In Hungary, clinical trial legislation was harmonized with the European standards in 2004. The approval process is relatively quick and straightforward. It is performed via a single authority — the National Institute for Quality and Organizational Development in Healthcare and Medicines (GYEMSZI). GYEMSZI is responsible for various aspects of drug production, registration, and pharmacovigilance.

Official links

https://fogalomtar.aeek.hu/index.php/GYEMSZI

The Regulatory Authority (RA) typically completes the review of a study within 60-days. Central Ethics Committee (CEC) reviews the study in parallel and usually provides the approval sooner than the RA. Approval from the LECs (Local Ethics Committees) is not required to begin the study. LECs oversee the clinical trial at the assigned sites.

Pharmaceutical Industry & Clinical Trials Market

The pharmaceutical sector is one of the main in the Hungarian economy, accounting for 7.5% of national GDP (2019).

Hungary has a highly innovative and well-organized infrastructure for clinical trials.

It is currently in top 10 countries in terms of the number of trials and 4^th in terms of accessibility and availability of trials per capita in the EU.

Medical system

Hungary has adopted a centralized health care system managed by the National Health Insurance Fund (Hungarian Országos Egészségbiztosítási Pénztár (OEP)). According to OECD, a free health insurance is provided to children under 16 years old, single parents, students, pensioners, people with an income below the subsistence level, people with disabilities and religious figures.