Accelerating Clinical Trials in Hungary with Effective Compliance Solutions
When it comes to conducting clinical trials, selecting the right location is a critical decision that can significantly impact the success of your research. Hungary has long been recognised as a prime destination for clinical trials thanks to its convenient geographic location and well-established regulatory framework.
In this article we explore the key factors that make Hungary an attractive location for conducting clinical research, with a particular emphasis on the importance of GMP (Good Manufacturing Practice) certification.
Hungary’s central European location and extensive motorway network is a key logistic advantage for the country. Stretching 93,030 square kilometres, this landlocked country benefits from three vital European transport corridors – Mediterranean, Orient-Mediterranean and Rhine-Danube, which provide unrivalled access across Europe. Excellent road, rail and air transport provides quick and easy access to patient centres.
Diverse Patient Populations
With a population of 9.7 million, combined with its strategic location, Hungary is an ideal hub for clinical trials. Its geographical position allows easy access for Western and Eastern participants offering a diverse patient pool across various backgrounds and medical conditions. This is particularly beneficial for those wishing to run multi-country trials. It also benefits from fast enrolment.
Excellent Healthcare Provision
Hungary operates a universal healthcare program for its population which is financed through a Health Insurance Fund (HIF). In July 2023, the Government announced a further EUR 1.13bn budget investment in healthcare for 2024. Healthcare spending has grown from Euros 2.85 billion to Euros 8.28 billion over the last 10 years.
The country is home to a pool of skilled healthcare professionals, clinical researchers and investigators with extensive experience. Its modern research facilities and hospitals provide first-in-class facilities for conducting clinical trials.
Hungary’s well-established regulatory framework is aligned with EU regulations, providing a smooth and efficient path to clinical trial approval. The National Centre for Public Health and Pharmacy (NNGYK), formerly OGYÉI, is responsible for the regulation of clinical trials within the country. It is their duty to ensure that the public are provided with safe and effective, quality medication that satisfies regulatory requirements.
The country places a strong emphasis on safety and compliance in clinical trials and adheres to international standards such as GCP (Good Clinical Practice) and ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). These are obligatory and regulated by local authorities. This ensures that the highest ethical and safety standards are met.
With a clear regulatory environment and favourable study start-up timelines, the average time from submission of a clinical trial to approval is 10 weeks.
One of the cornerstones of successful clinical trials is the quality and safety of investigational products used in studies. A declaration by a QP that manufacturing sites are compliant with EU GMP certification is a requirement for the conducting of studies in Hungary ensuring that pharmaceutical products are produced in line with quality standards. In addition to the manufacturing of pharmaceuticals, it also means that other functions can be undertaken such as kitting operations, labelling – including the extension of expiry dates, the importation of medical products into the EU from other countries as well as a range of secondary functions within the GMP licence.
Expediting Timelines with Oximio, Hungary
Established in 2020, Oximio, Hungary is conveniently located in Central Europe, a quick 50 minutes from Budapest Airport. This provides a strategic location for access between East and West Europe. The business has been accredited with both Good Manufacturing Practice (GMP) and Manufacturing and Importation Authorisation (MIA) certification. Our regional warehouse can support clinical trials across the EU and Eastern Europe with direct to site deliveries.
With segregated storage, the warehouse offers a range of temperature control systems from controlled ambient, refrigerated to ultra-low temperatures with cryogenic storage solutions by request. This provides storage capabilities for blood products, antibiotics and cytotoxic drugs to name but a few. Providing a range of comprehensive labelling and packaging service, we can assist with secondary packaging, additional labelling, kit assembly and coding of IMPs.
Our comparator sourcing services are available for the acquisition of both pharmaceuticals, medical equipment and equipment rental. A complete return, accountability and destruction service is also provided. The Hungarian team are developing strategic services, including adaptive logistics for cell and gene therapies and bio-banking.
With a team of qualified and experienced project managers, we can support you throughout your entire clinical trial, helping you navigate customs clearance, IOR and QP. We pride ourselves on the development of local expertise and compliance with global standards. We optimise clinical trial supply chains with consolidated logistics and supply solutions with the aim of expediting start-ups and reducing overall timelines.
Our services are designed to align with your requirements. Please contact us today and find out how we can support you with your clinical research.