CRED SMPC 2024

17/09/2024

CCDS Process Considerations

● Establish multi-disciplinary teams (usually per product) to evaluate new information & propose revisions to CCDS

● Regular company review of safety information (and benefit-risk) – Consider timelines, especially for safety changes – Clock starts from the ‘safety decision’ ● Consider a minimum review period if no triggers, e.g. annual review

● Formal procedure for internal approval of CCDSs

● Robust document management system – Version control ● Communication: Ensure dispatch to all that need

– Communicate submission deadlines where relevant (e.g. safety changes) ● Ensure documentation captured to demonstrate SOP has been followed

● Monitoring system for compliance of national labels with the CCDS – timing and content

The Organisation for Professionals in Regulatory Affairs

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CCDS references/support documentation

● The CCDS is a data-driven document ● Each CCDS data-driven statement should have references to support it ● Consider what documentation you will provide to support implementation of the CCDS into national labels e.g. clinical overview addendum

The Organisation for Professionals in Regulatory Affairs

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