Definition

Company's master document describing safety and efficacy; basis for local labeling (SmPC, PIL) and RSI for expedited reporting.

Example

CCDS updated after signal evaluation; all local labels updated accordingly.

Regulatory source

ICH E2D, GVP Module V

Common mistakes

Divergence between CCDS and local labels without justification.

Inspector question

How do you maintain consistency between CCDS and local RSI?

Related terms