REGISTRY SNAPSHOT: National Institute of Pharmacy and Nutrition (OGYEI)

by Staff writer,
Posted on 5/14/2019

Hungary budapest National Institute of Pharmacy and Nutrition (OGYEI) clinical trial registration results summaries transparency vendor services software trialassure

Streetcar in Budapest, home to the OGYEI

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)

Country: Hungary

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:

TrialAssure® Registry can automate the disclosure of clinical trial results for OGYEI. For questions or a free demo, fill out this form.

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