Medsafe
The new article describes in detail the application process to be followed by the interested parties when applying for authorisations in the context of clinical trials.
Medsafe
The new article explains the requirements pertaining to notifications for clinical trials, as well as the Good Clinical Practice requirements.
Medsafe
The new article clarifies the regulatory requirements related to record-keeping and reporting in the context of clinical trials.
Swissmedic
The article highlights the key points related to the regulatory requirements for combination studies intended to be carried out in Switzerland.
Swissmedic
The new article clarifies the approach to be followed when introducing modifications to combination studies already approved by Swissmedic.
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