In Hungary the authorization process for various kinds of medical research highly differ. We differentiate between clinical trials with investigational medical products, clinical trials with medical devices and interventional and non-interventional medical research.

1. Interventional medical research conducted on humans

Competent authority: National Public Health and Pharmaceutical Center (NNGYK, formerly: OGYÉI)

Ethics committee: One of the Committees of the Medical Research Council is responsible for ethical evaluation:

• National Scientific and Ethical Committee (TUKEB) - evaluates most of interventional medical research.
• National Ethics Committee for Human Reproduction (HRB) - evaluates single- and multi-site medical research dealing with interventions for human reproduction, with human genetics and advanced medicinal products (cell and gene therapy).
• Regional Scientific and Ethical Committees (RKEBs) - there are 10 such committees covering the territory of Hungary. They evaluate biomedical research of local or regional coverage, when the competent authority involves them.

2. Non-interventional medical research conducted on humans

Competent authority: National Scientific and Ethical Committee (TUKEB) evaluates all non-interventional medical research as competent authority.

3. Interventional and non-interventional medical device clinical trials

Competent authority: National Public Health and Pharmaceutical Center (NNGYK, formerly: OGYÉI)

Ethics committee: National Scientific and Ethical Committee (TUKEB)

4. Clinical trials with investigational medical products

Competent authority: National Public Health and Pharmaceutical Center (NNGYK, formerly: OGYÉI)

Ethics committee: National Ethics Committee for Clinical Pharmacology (KFEB)

If a researcher from University of Szeged plans to initiate a medical research or clinical trial on humans the colleagues of Competence Centre for Drug Development and Clinical trials are ready to guide them through the authorization process.

Contact:

Noémi MÉSZÁROSNÉ DR. SITERI – research manager

Email: meszarosne.siteri.maria.noemi@szte.hu