Phase IV Clinical Trials with Authorised Medicinal Products
The term "non-interventional study" does not exist in Swiss law. Clinical studies
have to be notified to Swissmedic if they correspond to the definition of a clinical trial given in Art. 5 of the Ordinance on clinical trials of therapeutic products (VKlin
See Swissmedic website http://www.swissmedic.ch/bewilligungen/00089/00282/index.html?lang=en
"Article 5 a VKlin only defines the term 'clinical trial' (Art. 5 a VKlin
), but not other projects such as non-interventional studies, post-authorization safety studies, application observations, and the like. If such projects are carried out using pharmaceuticals they are defined as clinical trials on pharmaceuticals (even if they are authorized preparations in an authorized application) and therefore come under the requirements of VKlin.
On the other hand, a clinical report need only be submitted to the cantonal ethics committee, and only when the cantonal regulations require this."Prospective and Retrospective NIS
Furthermore, according to communication with a representative from the clinical trials unit of swissmedic on the 2nd and 3rd June 2009:
"Prospective and Retrospective NIS which fit within the definition of an NIS provided in Article 37 of the SGCI COP
do not currently fall under the remit of VKlin
and do not require approval of, or notification to, swissmedic. The only current requirements for the conduct of NIS are prior REC approval."
According to swissmedic, this is likely to change when the new Federal Law on Human Research
(which was approved on 30th September 2011) is implemented in 2013. Non-interventional Studies using Authorized Medicinal Products
In accordance with Article 37 of the SGCI Code of Practice
, those studies which do not fall within the regulations of the Swiss legislation on Therapeutic Products for Clinical trials (e.g. reports on practical experience), and show the following characteristics, are considered non-interventional studies with authorized medicines:
Prospective Disease Registries
- An authorized medicinal product is prescribed, dispensed or applied by the health care professionals taking part in the investigations in the usual way, complying with the currently valid professional information.
- The involvement of patients in such an investigation is not determined in advance by an investigation protocol and the prescription, dispensing or use of medicines is clearly separate from the decision to include a patient in the investigation.
- No additional diagnosis or control measures are provided for patients; epidemiological methods are used for analyzing the collected data.
If you intend, for example, to study the progression of a disease by observing disease progression (longitudinal observational study) and wish to follow patients during their routine practice with an additional blood sample taken for genetic analysis, then according to recent communication with Swissmedic (28 Oct 2011), this type of study does not fall within the scope of Article 5a of VKlin and therefore requires only Research Ethics Committee approval.
If in doubt about the regulatory classification of your study contact Swissmedic
who are very efficient and will generally respond within 48 hours.