The principles of Good
Clinical Practice and the Declaration of Helsinki must be followed.
Before a clinical trial may be started, the trial design must be approved
by an Ethics Committee.
Authorisation for conducting a clinical trial has to be obtained from
the Medical Products Agency (MPA), the Swedish national authority
responsible, among other things, for the regulation and surveillance
of clinical trial research.
An application for authorisation must be submitted to the MPA. When
it has been verified that the application is valid (3 - 5 days), review
will normally be completed within 30 days. If no reply has been received
within 60 days, it can be assumed that the MPA has no objections to
the trial and authorisation is considered to have been granted.
In compliance with the EU Clinical Trials Directive 2001/20/EC, new provisions and guidelines on clinical trials came into force on 1st May 2004. According to the MPA, the implementation of the new EU Directive went very smoothly. Only minor changes were required in the Swedish regulations, since MPA approval for clinical trials was already obligatory before, and clinical trials in Sweden have been conducted in accordance with Good Clinical Practice for many years, both for commercial and non-commercial trials.
As a rule, investigational medicinal products should be made available free of charge by the sponsor; however, Swedish law allows for exemptions from this requirement, so non-commercial sponsors have not been deterred from performing clinical trials in Sweden. In 2003, one third of all clinical trial applications in Sweden were submitted by non-commercial sponsors/ investigators.
 Health
Care System |
| The majority of hospitals
and health services in Sweden are public. The health care system
is funded for the most part by taxes, but private health care
also exists. |
|
SWEDEN 
