CRED SMPC 2024

17/09/2024

What is a CCDS and what is its purpose?

Company internal reference document – Summarises the company position on the safety and efficacy of a product – Basis for all Product Information globally – Mechanism for driving consistency across labelling globally – Vehicle for communicating company-driven labelling changes to affiliates and partners – Dynamic document: updated as new information becomes available – Reference Information* for PSUR/PBRER

*GVP Module VII (Rev 1)

The Organisation for Professionals in Regulatory Affairs

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Origins of the CCDS

CIOMS: Council for International Organizations of Medical Sciences est. 1949 – Guidelines for Preparing Core Clinical Safety Information on Drugs Second Edition CIOMS III and V (1999): Working Group focused on international harmonisation of practical aspects of defining, creating and updating safety information in labels “A document prepared by the pharmaceutical manufacturer, containing (among other things) all relevant safety information , such as adverse drug reactions, which the manufacturer requires to be listed for the drug in all countries where the drug is marketed . It is the reference document by which ‘labelled’ and ‘unlabelled’ are determined for the purpose of international ADR reporting”.

The Organisation for Professionals in Regulatory Affairs

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