MHRA
The article provides an overview of the current reporting requirements for healthcare products allowed to be used for clinical trials.
Swissmedic
The article highlights the key points related to the regulatory requirements for combination studies intended to be carried out in Switzerland.
FDA
The new article elaborates further on the submission of use-related risk analyses, and also provides certain examples intended to demonstrate the way the regulatory approach described in the guidance should be applied.
Australia
The article highlights the key points related to the application of certain essential principles intended to ensure the safety and proper performance of healthcare products allowed to be marketed and used in Australia.
Swissmedic
The article outlines the key points related to Swissdamed, the country’s new information system for healthcare products.
