Clinical research in Hungary. Infrastructure, organisation, legislation and framework. The situation in 2008.
The European Clinical Research Infrastructures Network (ECRIN) is designed to improve the capacity and quality of the clinical research in Europe and promote innovative pharmaceutical development. The regulation of the company-sponsored clinical trials is functionally acceptable, but other type of investigations (investigator initiated trials, trials of psychology, food supplements, devices, etc.) needs further harmonisation. Hungary joined ECRIN in 2005 and performed a lot of queries in regulation, legislation, monitoring, safety, pharmacovigilance, data management, quality assurance, etc., which are presently summarized in this paper in order to show the present situation of the complicated issues of clinical research in Hungary. This "country report" summarizes the present legislative and regulatory frames including the necessary issues being attached: organizing and setting-up the first representatives of clinical study centres into a network, which will facilitate the organisation and performance of multinational studies in various research areas.
Blaskó
György
G
Department of Pharmaceutical Management and Organisation, University of Debrecen Medical and Health Science Centre, School of Pharmacy, Debrecen Egyetem, Hungary. blaskogy@mail.externet.hu
Kardos
Gabriella
G
D035843:Biomedical Research / Q000331:legislation & jurisprudence* / Q000458:organization & administration* / Q000592:standards / Q000639:trends; D002986:Clinical Trials as Topic / Q000639:trends; D016494:Computer Security; D004345:Drug Industry; D004864:Equipment and Supplies; D032984:Ethics, Research; D006814:Hungary; D011358:Product Surveillance, Postmarketing