Swissmedic Information Sheet on Combination Studies: Overview
The article highlights the key points related to the regulatory requirements for combination studies intended to be carried out in Switzerland.
The article highlights the key points related to the regulatory requirements for combination studies intended to be carried out in Switzerland.
The new article provides further clarifications regarding the authorisation procedure to be followed by the parties interested in conducting combination studies in Switzerland.
The new article clarifies the approach to be followed when introducing modifications to combination studies already approved by Swissmedic.
The new article outlines the reporting requirements to be followed by the parties responsible for clinical investigations conducted in Switzerland.
The article outlines the key points related to Swissdamed, the country’s new information system for healthcare products.
The new article describes in detail certain specific aspects related to the incident reporting requirements introduced in Switzerland.