Approval Process
Hungary is a European Union (EU) member since 1st of May 2004. The clinical trial legislation has been harmonized with the EU. Hungary does not have diversified competent authorities. The National Institute for Quality and Organizational Development in Healthcare and Medicines (GYEMSZI) is the governmental health authority being responsible for registration, auditing, GMP controlling, pharmacovigilance, etc. Approval process is relatively short and simple.
- realistic start-up time: 3.5 – 4 months
Recruitment Potential
Hungary is one of the leaders in the European region with regards to the number of clinical trials conducted.
The leading causes of death in Hungary are:
- malignant neoplasm (Hungary has one of the highest incidence rate of lung cancer in the world and the second highest colorectal cancer incidence in Europe
- cardiovascular (mainly acute myocardial infarction) and cerebrovascular diseases
- bronchitis, emphysema and asthma
- chronic liver disease and cirrhosis
Mental health problems (high depression and suicide rates) represent a key problem in Hungary.
Estimated deaths per 100,000 population by cause (higher than world/European average):
| Diseases | Hungary | World Average | Europe Average |
|---|---|---|---|
| Cardiovascular diseases | 646.1 | 240.9 | 465.2 |
| Neoplasms | 329.5 | 222.1 | 236.2 |
| Digestive diseases | 77.9 | 32.0 | 30.9 |
| Respiratory diseases | 56.9 | 53.3 | 48.8 |
| Neurological conditions | 38.9 | 27.4 | 59.5 |
| Diabetes Mellitus | 26.0 | 21.6 | 19.4 |
| Mental and substance use disorders | 7.0 | 4.3 | 11.1 |
| Musculoskeletal diseases | 3.0 | 2.1 | 2.8 |
Data from World Health Organization
Investigators and Sites
The high standard of medical and research expertise, investigators’ quality and experience, as well as the significant pool of patients in certain diseases have attracted many biotech companies to conduct clinical trials in this country. Four medical universities and two National Institutes (Oncology and Cardiology) are the backbone of the site network. In total, there are over 650 sites in Hungary, both public and privately owned.