Definition

The reference document maintained by the MAH containing all relevant safety information about a product, serving as the basis for national labels and expectedness determination.

Example

When a new adverse reaction is confirmed through signal evaluation, the CCSI is updated first, then variations are submitted to align individual country labels.

Regulatory source

ICH E2C(R2), EU GVP Module V

Common mistakes

Allowing regional labels to diverge from CCSI without systematic tracking and justification.

Inspector question

How do you maintain your CCSI? How do you ensure alignment between CCSI and regional labels?

Related terms