Before a clinical trial
can commence, it has to be approved by the Ethics Committee of the
Ministry of Social Affairs and Health. Good Clinical Practice and
the Declaration of Helsinki must be observed.
The National Agency for Medicine (NAM) is responsible for overseeing
clinical trials and carrying out inspections. Prior to conducting
a clinical trial, the manufacturer of a medicinal product, the applicant
for (or the holder of) a marketing authorisation or the investigator
performing the trial must notify the National Agency for Medicine
60 days before the intended start of the trial. The notification has
to be accompanied by relevant documents including the trial protocol
and the opinion of the Ethics Committee.
Health
Care System |
| Finland's health care
system is funded for the most part by taxes, but there is also
a private health care system as well as a mandatory health insurance
policy scheme. |
|