ABSTRACT
Ethical approval is required by the Slovene Directive on Clinical Drug Trials for all clinical trials of pharmaceutical products. Slovenia has also started to implement the provisions of the European Directive 2001/20/EC on the application of Good Clinical Practice in the conduct of clinical trials on medicinal products for human use. Slovenia has signed and is expected to ratify the Additional Protocol to the Convention on Human Rights and Biomedicine, on Biomedical Research. This should provide a basis for the new law on biomedical research, regulating among other things, ethical review of research in great detail. The Health Minister appoints members to the National Medical Ethics Committee (NMEC) from a selection of reputed experts nominated by the Medical School, the National Health Council, and the Slovene Medical Chamber. The Slovenian Directive on Clinical Drug Testing, regulating good clinical practice in the field of pharmaceutical research and research on medical appliances, is based on this Directive.
