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AUTHORITIES

Health Sciece Council 

National Pharmaceutical and Food Health Institue

National Health Serviced Provider Centre (ÁEEK)

Centre for Health Records and Training

European Medicines Agency (EMA)

Food and Drug Administration (FDA)

 

LAWS

1997. CLIV. törvény az egészségügyről 

2006. évi XCVIII. törvény A biztonságos és gazdaságos gyógyszer- és gyógyászatisegédeszköz-ellátás, valamint a gyógyszerforgalmazás általános szabályairól

2005. évi XCV. törvény Az emberi alkalmazásra kerülő gyógyszerekről és egyéb, a gyógyszerpiacot szabályozó törvények módosításáról

 

REGULATIONS

235/2009. (X. 20.) - Government Decree on the rules of medical research conducted on humans, human
clinical trials of investigational products, and human clinical trials of medical devices

23/2002. (V. 9.) - Government Decree on medical research conducted on humans3/2002

35/2005. (VIII. 26.) - Government Decree on the clinical trials of investigational products for human use, and
the application of good clinical practice

33/2009. (X. 20.) - Government Decree on the clinical trials of medical devices

 

RECOMMENDATIONS

235/2009. (X. 20.) - Government Decree on the rules of medical research conducted on humans, human
clinical trials of investigational products, and human clinical trials of medical devices

23/2002. (V. 9.) - Government Decree on medical research conducted on humans

35/2005. (VIII. 26.) - Government Decree on the clinical trials of investigational products for human use, and
the application of good clinical practice

33/2009. (X. 20.) - Government Decree on the clinical trials of medical devices

 

 

REGIONAL RESEARCH ETHICS COMMITTEE

Regional Research Ethitcs Committee

 

PROFESSIONAL BODIES

Hungarian Association of Clinical Trial Organizers (MKVT)

 

REPRESENTATIVE FOR PATIENT RIGHTS

Representative for patient rights

 

RESEARCH PROPOSAL

HECRIN consortium (EFOP-3-6-2-16-2017-00009)
 

 

PRESENCE IN THE PRESS

PTE ORVOSKARI HÍRMONDÓ JANUARY 2018 - SPONSORS' OPINION ABOUT HUMAN CLINICAL TRIALS AT THE UNIVERSITY OF PÉCS (page 27).