company core safety information
- Guideline or reference source
- ICHE2C(R2) Guideline
- Definition
- All relevant safety information contained in the CCDS prepared by the MAH and which the MAH requires to be listed in all countries where the company markets the drug, except when the local regulatory authority specifically requires a modification. It is the reference information by which listed and unlisted are determined for the purposes of periodic reporting for marketed products, but not by which expected ad unexpected are determined for expedited reporting.
- Abbreviation for
- CCSI
- Related Term
- company core data sheet
- reference safety information
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