All clinical trials taking place in Iceland are subject to approval by the National Bioethics Committee (NBC).
Within 60 calendar days from receiving a completed application, the NBC shall submit a reasoned opinion on ethical issues to the applicant and the Icelandic Medical Agency (IMA). The assessment of a completed application to the NBC starts when the NBC‘s Office issues acknowledgement in writing of receiving a completed and signed application and enclosures (cf Art 6 of regulation nr. 443/2004, on clinical trials, elsewhere on this homepage).
It is for the benefit of applicants to complete their applications carefully. When the NBC‘s office has confirmed its receipt of a complete application, the 60 calender days limit starts to count.
The NBC may request additional documents once during the 60 days period. While NBC awaits additional documents the clock stops counting. This rule limits the exchange of information between the applicant and NBC‘s Office to one letter with remarks from the NBC during the assessment period.
The NBC may extend the assessment period for up to 30 calendar days in case of biomedical study involving drugs for genetic treatment or treatment with bodily cells or drugs containing genetically modified organisms. In case the NBC needs to seek external advice, the total assessment period from receiving a completed application can be extended up to 180 calendar days. If the NBC decides to extend time limits for assessing completed application the principal investigator must be notified.
No time limit has been defined for assessing trials in medical treatment with animal cells.