Company Core Data Sheet(CCDS)

Company Core Data Sheet(CCDS)

A document prepared by the marketing authorization holder containing, in addition to safety information, material relating to indications, dosing, pharmacology and other information concerning the product.

The CCDS is required to judge whether an adverse event or adverse drug reaction is labeled / listed or unlabelled / unlisted and is therefore always included in a periodic safety update report (PSUR).

In many countries involved in the international conference on harmonization (ICH) as members or observers, this kind of document is similar to the labelling approved as part of the marketing authorisation, although there are often differences because of differences in the scope of the document, principles for inclusion, indications and / or recommended dosage of the drug, experience drawn from pre-registration studies and from the market, local habits for concomitant drugs and local or ethnic sensitivity. The classification ‘labeled’ or ‘unlabelled’ has many more consequences for expedited reporting than for periodic reporting. The CCDS must be dated, including the date of last revision (or all revision dates).
 
CCDS are usually prepared by an applicant for a drug substance (active ingredient) rather than a drug product because post-marketing PSUR’s and IPSR’s would be based on a drug substance.

Source:  EU Guidelines