Company Core Data Sheets (CCDS)
CCDS is a core central internal regulatory document prepared by the Marketing Authorization Holder (MAH) containing information pertaining to indications, dosing, pharmacology and other information concerning the marketed pharmaceutical or biological product in addition to safety information.
The concept of a CCDS was proposed by CIOMS guideline to provide reliable and consistent data across the markets globally, as it is necessary to ensure patient safety and should be accepted world wide.
The core purpose of CCDS is –
- To harmonize the safety information of any drug product across the globe and contains regulatory authority-approved information on the respective product.
- To have updated and accurate “Reference Safety Information” in order to carry out all the Pharmacovigilance activities.
- To judge whether an adverse event or adverse drug reaction is labeled / listed or unlabeled / unlisted for the product, this is required for the regulatory processes.