The approval process is following the EU legislation (clinical trial directive 2001/20 EC), including the Austrian Medicinal Drug Law.
- realistic approval time: 3 months.
Competent Authority in Austria
BASG (“Bundesamt für Sicherheit im Gesundheitswesen”/Federal Office for Safety in Health Care) is the only competent authority in Austria to which applications have to be submitted. Within this CA the AGES (“Agentur für Gesundheit und Ernährungssicherheit”/Agency for Health and Nutrition Safety) is responsible for approval of clinical trials. They are responsible for approval of all medicinal products including medical devices. Approval is given within 35 days.
Austria is an attractive country for clinical research and the number of clinical trials has been fairly constant over the last few years. In 2013 ca. 7,000 patients were included in 500 clinical trials. The majority of clinical trials are conducted in oncology, while the majority of patients included in trials have been in heart and circulation indications. Five per cent of trials are conducted in rare diseases, often affecting children.
Estimated deaths per 100,000 population, by cause (higher than world/European average):
|Diseases||Austria||World Average||Europe Average|
|Endocrine, blood, immune disorders||13.1||5.6||5.5|
|Mental and substance use disorders||8.3||4.3||11.1|
Data from World Health Organization