CCSI(Company Core Safety Information)

All relevant safety information contained in the company core data sheet (CCDS) prepared by the marketing authorization / licence holder and which the MA holder requires to be listed in all countries where the company markets the drug, except when the local regulatory authority specifically requires a modification

The CCSI is the reference information by which listed and unlisted are determined for the purpose of periodic reporting for marketed products, but not by which expected and unexpected are determined for expedited reporting.

For the purpose of periodic Safety Update Report, the CCSI forms the basis for determining whether an ADR is already listed or is still unlisted.

For a clinical trial, the CCSI is the company core data sheet, prepared by the MAH of a marketed product when it is used as an investigational medicinal product, except when the local regulatory authority specifically requires a modification. For investigational products the CCSI is the Development Core Safety Information.