Clinical trials in Switzerland
are regulated by the new Law on Therapeutic Products (Federal Law
on Medicinal Products and Medical Devices, "HMG"), which
was approved by Parliament in December 2000 and came into force on
1st January 2002, as well as the Ordinance on Clinical Trials of Therapeutic
Products ("VKlin"), which also came into effect on 1st January
2002. This legislation is in line with European Union legislation
and provides standardised provisions for Switzerland as a whole, replacing
the earlier provisions based on cantonal and intercantonal legislation.
A new federal regulatory body, the Swiss Agency for Therapeutic Products
(Swissmedic), was created and came into operation on 1st January 2002.
It is responsible for authorising the testing and marketing of pharmaceutical
products and medical devices.
All clinical trials must be carried out in accordance with the principles
of Good Clinical Practice.
Before a clinical trial can be conducted, the favourable opinion of
the competent Ethics Committee responsible for the trial site must
be obtained. The ordinance "VKlin" lists details of the
documentation to be submitted. After receiving all the required documents,
the Ethics Committee will give an opinion within 30 days.
The sponsor must notify Swissmedic of a clinical trial in advance by submitting a notification form, the complete documentation and the approval of the Ethics Committee. The clinical trial can begin when authorisation has been granted - or if no objections have been received from Swissmedic within 30 days (or 60 days in the case of clinical trials with radiopharmaceuticals). Swissmedic will inform the involved cantons about the clinical trial.
 Health
Care System |
| Swiss health care has
an excellent international reputation. In addition to the public
hospitals there are about 170 private hospitals, which provide
approximately one-fifth of the hospital services. |
|
SWITZERLAND
