Clinical trials in Hungary

Hungary. Country Overview
Hungary is a European country. Hungary is located in Central Europe and is bordered by several European countries, including Austria, Slovakia, Ukraine, Romania, Serbia, Croatia, and Slovenia. Hungary is a member of the European Union (EU). Its capital city is Budapest, often referred to as the "Heart of Europe".
The population of Hungary is estimated at approximately 9.7 million people.
Healthcare in Hungary is provided through a universal healthcare system, where the government is responsible for ensuring access to healthcare services for all citizens. The Hungarian healthcare system is primarily financed by taxes and contributions to the National Health Insurance Fund (NHIF).
The Hungarian healthcare system provides universal coverage, meaning that all Hungarian citizens and residents with valid social security or health insurance are entitled to healthcare services. Coverage extends to a wide range of services, including preventive care, diagnostics, treatment, hospital care, and medications.
The primary health care system in Hungary is based on a model in which patients must first consult a general practitioner (GP) or family doctor, who serves as the first point of contact for non-emergency health care needs. The GP then refers patients to specialists or hospitals as needed.
Hungary has a network of public health care facilities, including hospitals, clinics and specialized medical centers. Private healthcare facilities are also available, and individuals have the option of seeking care from private providers at their own expense or through private health insurance.
Hungary has a well-developed healthcare infrastructure, including well-equipped medical facilities and research centers that can support the conduct of clinical trials. The country has a number of specialized hospitals and clinical trial centers with state-of-the-art technology and experienced staff. An adequate healthcare infrastructure is crucial for the smooth conduct of clinical trials.
Conducting clinical trials in Hungary can be cost effective compared to some other countries. The costs associated with conducting trials, such as site fees, investigator fees, and patient recruitment expenses, can be relatively lower compared to countries with a higher cost of living or more expensive healthcare systems. Site fees, investigator fees, patient recruitment costs and administrative costs may be lower in Hungary than in other European countries. Conducting clinical trials can be cost effective for trial sponsors.
In 2021, Hungary had approximately 45,000 physicians. In 2021, Hungary had approximately 172 hospitals. In 2021, Hungary had about 62,000 hospital beds.
Investigators in Hungary have a good track record in conducting clinical trials, therapeutic area expertise, and access to patient populations. Experienced investigators can contribute to the success and credibility of the study.
Hungary has a high literacy rate, indicating a strong emphasis on education and literacy in the country. In 2021, the literacy rate in Hungary is estimated to be close to 99%. This means that the vast majority of the population over the age of 15 can read and write proficiently. Patients' full understanding of the ICF process is one of the most important factors ensuring compliance with ethical standards and protection of patients' rights.
In 2021, approximately 71% of the population in Hungary lived in urban areas, while the remaining 29% lived in rural areas. The country has several major cities, with Budapest being the most populous and serving as the political, economic, and cultural center of Hungary. High urbanization is a positive factor for the conduct of clinical trials, as patients are concentrated in large cities. 
The leading causes of mortality in Hungary, based on available data, include
  • Cardiovascular diseases
  • Cancer diseases
  • Respiratory diseases
  • External causes
  • Liver diseases
  • Diabetes mellitus
Ischemic heart disease and stroke are the leading causes of death, accounting for one-third of all registered deaths in Hungary in 2018. Among cancers, lung cancer is the leading cause of death, followed by colorectal, pancreatic, and breast cancer.
According to estimates by the Joint Research Center, more than 62,000 new cancer cases are expected to be registered in Hungary in 2020. This corresponds to an estimated 623 cancer cases per 100 000 inhabitants, which is 10% higher than the EU average.
Hungary's cancer mortality rate is also expected to be high in 2020, at 330 deaths per 100 000 people, compared with 263 per 100 000 in the EU.
Risk factors such as smoking, alcohol consumption and unhealthy diets are more prevalent in Hungary than in other EU countries. These have contributed to relatively high rates of preventable mortality, such as cancer and cardiovascular disease.
Considering the prevalence of diseases in Hungary, the country can offer high patient recruitment potential for some trials.
The pharmaceutical sector is one of the main pillars of the Hungarian economy, accounting for 7.5% of the national GDP. A developed pharmaceutical industry also translates into a developed clinical trial infrastructure. All leading CROs, laboratories, central depots and other clinical trial service providers have a presence in Hungary. The country also has a large number of Phase I units. 
Clinical Trials Landscape in Hungary
As of May 2023, there were 4,927 clinical trials registered in Hungary on 1,087 trials were ongoing. 917 trials were industry-sponsored interventional studies. Most of the studies are phase II and III studies. 
The FDA registered 34 new drugs in 2020. 9 of these drugs were tested in clinical trials in Hungary. 
Hungary has a high level of patient engagement and participation in clinical trials. The country has a strong culture of clinical research and a positive perception of clinical trials among the population. This positive attitude facilitates faster patient recruitment and enrollment, which is critical to the timely completion of clinical trials.
Hungary ranks 10th in the world in terms of the number of trials conducted in the country and 4th in Europe (based on the number of patients relative to the population). 
Quality of clinical trials in Hungary
The FDA conducted 40 inspections in Hungary. 26 resulted in NAI (no action indicated) and 14 in VAI (voluntary action indicated). This indicates a high quality of clinical trials in Hungary.
Regulatory Environment in Hungary
Hungary follows the EC guidelines for clinical trials. The expected timeline of clinical trial application is 60 days. The regulatory bodies that review CTAs are 
  • The National Institute of Pharmacy and Nutrition (NIPN), Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet (OGYÉI)] 
  • The Central Ethics Committee, and the Medical Research Council (MRC), Egészségügyi Tudományos Tanács (ETT).
Hungarian sites also have LECs. The local ethics committees do not approve trials, but are responsible for local oversight of trials and require notification of trial initiation, termination, and local SAEs.
As of January 31, 2023, the use of CTIS will be mandatory for all first-time clinical trial applications in the European Union (EU). CTIS is a unique platform for the submission, evaluation and monitoring of clinical trials in the EU/EEA. 
All clinical trial documents must be prepared in accordance with European requirements.
For non-EU sponsors, it is necessary to be prepared to prepare IMPD and go through the qualified person release procedure. 

Summary. Clinical Trials in Hungary

Hungary has many advantages for conducting clinical studies. These advantages include:
  • Short clinical study approval time.
  • Fast enrollment.
  • Big economic advantages.
  • High site productivity.
  • Big clinical trial potential in key therapeutic areas.
  • Developed clinical study infrastructure.
  • Proven quality of clinical trials. 25% of drugs approved in the USA have been tested in Hungary. 
Smooth Drug Development - CRO in Hungary
Smooth Drug Development is a CRO in EC, EAEU and India. We provide full service clinical trials. Smooth Drug Development has a presence in Hungary that effectively manages regulatory and contracting processes to ensure that studies can get up and running in the quickest time possible. We have experienced personnel to ensure that each trial managed by our team in Hungary produces exceptional quality data and results.