Module 6

04/10/2024

Company Core Data Sheet (CCDS)

A CCDS (Company Core Data Sheet) is a comprehensive document that standardizes the language for key labelling components across all regions, including:

• Indications: Clear statements of the approved uses for the product.

• Contraindications: Specific situations or conditions where the product should not be used. • Warnings and Precautions: Important safety information to be considered before use.

• Adverse Reactions: Documented side effects and unexpected responses associated with the product.

• Dosage: Recommended guidelines for administration to ensure efficacy and safety.

The primary focus of a CCDS is to emphasize safety information, ensuring consistency and clarity across different markets.

The Organisation for Professionals in Regulatory Affairs

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Authoring of the SmPC

● Developed from the CCDS and other data generated in the MAA for EU audience

● Usually initiated after Phase 3 results are available

● Must adhere to EU guidelines and templates

CMC

● Regulatory intelligence - review precedents

Non Clinical

● Differentiation – reflect in SmPC

Clinical

– Drives development

RA Lead the Authoring of the SmPC

Medical

– Supports access and promotion

● What is essential?

PV

Marketing

● What is negotiable?

Market Access

The Organisation for Professionals in Regulatory Affairs

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