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Good Clinical Practice is now Obligatory in Academic Clinical Drug Research in the European Union
Author(s) -
Jørgensen Annette,
Bach Karin Friis,
Friis Karen
Publication year - 2004
Publication title -
basic and clinical pharmacology and toxicology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.805
H-Index - 90
eISSN - 1742-7843
pISSN - 1742-7835
DOI - 10.1111/j.1742-7843.2004.pto940201.x
Subject(s) - european union , directive , clinical trial , danish , quality assurance , good clinical practice , clinical research , good manufacturing practice , clinical practice , medicine , drug , quality (philosophy) , political science , public relations , medical education , business , pharmacology , public administration , family medicine , regulatory affairs , computer science , linguistics , philosophy , external quality assessment , pathology , epistemology , economic policy , programming language
By May 2004, all clinical trials in the European Union (EU) on medicinal products have to be initiated and conducted in compliance with the principles in the new directive on Good Clinical Practice (GCP). This requirement will also apply to non‐commercial trials involving registered drugs and may therefore restrain the academic clinical drug research. In Denmark, three public GCP units connected in a national network and associated with the university hospitals in Copenhagen, Odense and Aarhus have been established. The GCP units offer academic researchers the necessary quality assurance and quality control systems to ensure that clinical drug research can be performed according to GCP. The Danish initiative is presented here as a contribution to the future work with implementation of the principles of GCP in academic clinical drug research in the European Union.