Clinical trials must be
conducted according to the Norwegian Regulations concerning Clinical
Trials of Medicinal Products of 1999, and in accordance with Good
Clinical Practice and the Declaration of Helsinki.
All clinical trials must be evaluated by the Regional Ethics Committee
before they are initiated.
Moreover, all clinical trials have to be assessed by the Norwegian
Medicines Agency (NMA) in advance. For this purpose a notification,
including the clinical trial protocol, must be submitted. A written
preliminary or final assessment will be given by the NMA within 30
working days after receipt of the notification. The trial can be started
when the final assessment is available, unless the trial is refused.
 Health
Care System |
| The NMA is the national
regulatory authority on assessment and surveillance of new and
existing medicines in Norway. The NMA reports to the Ministry
of Health. |
|
NORWAY
