Knowing which countries to submit clinical trial results summaries to is the easy part. What becomes difficult is learning the intricacies and transparency requirements of every clinical trial registry globally, including the Hungarian National Institute of Pharmacy and Nutrition (OGYEI). Here is an overview of this registry:
Registry name: National Institute of Pharmacy and Nutrition (OGYEI)
Year established: 2015 (when the National Institute of Quality and Organizational Development in Healthcare and Medicines transferred its power to authorize medicines and license clinical trials to OGYEI).
Points of interest:
- The OGYEI is Hungary’s health authority that oversees clinical trials of medicinal products. The institute is responsible for the medicinal product registration, scientific advice, drug testing, market surveillance, and the classification of clinical trials—including interventional and non-interventional trials.
- In 2015, the National Institute of Quality and Organizational Development in Healthcare and Medicines transferred its power to authorize medicines and license clinical trials to the OGYEI
- The OGYEI operates under the Ministry of Health, Department of Pharmaceuticals and Medical Devices.
- Titles of studies must be provided in both English and Hungarian, while the protocol summary must be written in Hungarian
- Hungary’s clinical trial legislation has been harmonized with the EU Clinical Trial Directive
- Under Hungary’s Decree 35/2005, the sponsor and the investigator must archive the clinical trial documents for a minimum of five years after the trial’s completion. The sponsor must also designate a person in charge of archiving the documents.
Related transparency research/articles:
- An Expert Opinion of the Hungarian Clinical Trial Management Society on the public consultation paper issued by the European Commission on “Assessment of the Functioning of the Clinical Trials Directive” 2001/20/EC
- EU Clinical Trials Register: Hungary
- CenterWatch: Hungary Clinical Trials
- EUREC National Information: Hungary
TrialAssure® Registry can automate the disclosure of clinical trial results for OGYEI. For questions or a free demo, fill out this form.