If you need a CRO to run a clinical trial in Hungary, please contact us at info@sofpromed.com
Hungary has emerged as a premier destination for conducting clinical trials, leveraging its advanced healthcare infrastructure, streamlined regulatory framework, and vast pool of experienced medical professionals.
In this article you will learn about:
- $Hungary's Clinical Trial Landscape: An Overview
- $Therapeutic Focus and Trial Phases
- $Sponsor Diversity
- $Clinical Trial Approval: A Streamlined Process
- $Site Agreements and Investigator Requirements
- $Patient Recruitment and Retention
- $Diversity and Accessibility
- $Incentives and Reimbursement
- $Quality Assurance and Safety
- $Operational Considerations
As a member of the European Union since 2004, the country has harmonized its clinical trial legislation with EU standards, making it an attractive option for biotech and medical device companies seeking to accelerate their product development timelines.
In this comprehensive guide, we delve into the nuances of running clinical trials in Hungary, highlighting the key advantages, regulatory requirements, and best practices that can help sponsors and contract research organizations (CROs) navigate the landscape with confidence.
Hungary’s Clinical Trial Landscape: An Overview
Hungary boasts a robust healthcare system with universal coverage, catering to a population of over 10 million.
The country’s medical research infrastructure is well-developed, featuring a network of clinical research centers and hospitals that serve a diverse patient population.
This, coupled with a large pool of highly skilled and motivated investigators, makes Hungary an appealing choice for conducting clinical trials across a wide range of therapeutic areas.
Therapeutic Focus and Trial Phases
According to the latest data, the highest number of ongoing clinical trials in Hungary are in the field of oncology, followed by pulmonology, cardiology, gastroenterology, and neurology.
The majority of these trials are in Phase 3, reflecting the country’s strong capabilities in late-stage clinical development.
Sponsor Diversity
International sponsors account for the vast majority of clinical trials conducted in Hungary, underscoring the country’s appeal to global pharmaceutical and medical device companies.
This diverse sponsor landscape ensures that participants have access to the latest innovative therapies, contributing to the advancement of medical science.
Clinical Trial Approval: A Streamlined Process
The clinical trial approval process in Hungary is both efficient and aligned with European Union standards.
The National Center for Public Health and Pharmacy (NNGYK) is the competent authority responsible for overseeing the regulation of clinical trials in the country.
Application Submission and Review
Clinical trial applications must be submitted through the EMA’s CTIS portal, with the NNGYK playing a crucial role in the evaluation process.
The review typically takes around 60 days, with a parallel assessment of Parts I and II of the application documents within 45 days.
Ethics Committee Approval
The Hungarian Central Ethics Committee (ETT-KFEB) is the sole ethical body involved in the review and approval of clinical trials.
This centralized approach ensures consistency and streamlines the decision-making process.
Site Agreements and Investigator Requirements
Hungary’s healthcare system often employs a single-contract approach between the sponsor and the trial site, simplifying the contracting process.
Additionally, investigators must possess a valid GCP certificate and submit a Protocol Agreement Form to demonstrate their understanding of the investigational plan and commitment to compliance.
Patient Recruitment and Retention
Hungary’s centralized healthcare system and diverse patient population make it an attractive destination for patient recruitment.
Sponsors and CROs can leverage the country’s well-developed infrastructure and experienced medical professionals to efficiently identify and enroll eligible participants.
Diversity and Accessibility
With a population that is predominantly urban and spans a wide age range, Hungary offers a diverse pool of potential trial participants.
The country’s advanced transportation network, with excellent connectivity to even the most remote areas, further enhances access to clinical trial sites.
Incentives and Reimbursement
While offering direct financial incentives to participants is restricted for certain trial phases, Hungary generally requires the reimbursement of patient expenses, such as travel and accommodation, to facilitate their participation.
Quality Assurance and Safety
Hungary’s clinical trial ecosystem is underpinned by a robust quality assurance framework, ensuring the highest standards of data integrity and participant safety.
Auditing and Inspections
Sponsors and CROs can expect regular internal audits and potential regulatory inspections to verify compliance with applicable guidelines and regulations.
The country’s proven track record of delivering high-quality data, as confirmed by FDA and EMA audits, underscores its commitment to quality.
Pharmacovigilance and Safety Reporting
Strict requirements for pharmacovigilance activities, including the preparation and submission of safety listings and reports, are in place to safeguard the well-being of trial participants.
Operational Considerations
Navigating the nuances of conducting clinical trials in Hungary requires a deep understanding of local regulations, language requirements, and logistical best practices.
Language and Documentation
While essential trial documents can be submitted in English, patient-related materials, labels, and protocol synopses must be translated into Hungarian.
Sponsors and CROs must also ensure that the Informed Consent Form (ICF) is tailored to include country-specific details.
Budgeting and Contracting
Early planning for budgeting and contracting is crucial, as the contracting process may take longer than the regulatory or ethics committee approval.
Contracts can be executed prior to obtaining regulatory authorization but will only be deemed valid upon study approval.
Patient Insurance and Compensation
Clinical trial insurance, covering health-related injuries to participants, is mandatory in Hungary.
Additionally, the provision of patient reimbursement for expenses, such as travel and accommodation, is generally required.
Partnering with a Specialized CRO
Navigating the complexities of conducting clinical trials in Hungary can be daunting, especially for sponsors and CROs unfamiliar with the local landscape.
Partnering with a local specialized CRO that has a strong regional presence and deep expertise in the Central and Eastern European (CEE) market can be a game-changer.
Local Expertise and Connections
A CRO with a dedicated team in Hungary, well-versed in the country’s regulatory requirements and clinical trial landscape, can ensure seamless study initiation and execution.
Furthermore, established relationships with local investigators, sites, and regulatory authorities can streamline the entire process.
Quality Assurance and Compliance
A reputable CRO with a robust quality management system and a proven track record of delivering high-quality data can give sponsors the confidence that their trials will be conducted in adherence to the highest standards of compliance and participant safety.
Accelerated Timelines and Efficient Enrollment
Leveraging a CRO’s local knowledge, patient recruitment strategies, and established site network can significantly shorten the time required for study start-up and patient enrollment, ultimately accelerating the overall clinical development timeline.
Conclusion
Hungary’s clinical trial landscape presents a compelling opportunity for sponsors and CROs seeking to accelerate their product development efforts.
With its streamlined regulatory framework, advanced healthcare infrastructure, and diverse patient population, the country has emerged as a premier destination for conducting high-quality, efficient clinical trials.
By understanding the nuances of the Hungarian market, adhering to local regulations, and partnering with a specialized CRO, sponsors can unlock the full potential of this dynamic clinical trial environment and drive meaningful progress in their research and development initiatives.
If you need a CRO to run a clinical trial in Hungary, please contact us at info@sofpromed.com
