Summary of Regulatory Terms

 Company Core Data Sheet (CCDS)

An evidence-based reference document that comprises company's global view of the profile of a specific product and represents clinical, nonclinical, scientific, and technical data, and other relevant information. The CCDS describes the full scope of benefit information based on adequate data and establishes the essential safety information (CCSI) for regulatory submission in all local or regional product labeling. The CCDS is a reference for the development of local labeling, as well as periodic safety reports.

Company Core Safety Information (CCSI)

For medicinal products, all relevant safety information contained in the company core data sheet prepared by the marketing authorization holder and which the marketing authorization holder requires to be listed in all countries where the company markets the product, except when the local Regulatory Authority specifically requires a modification (GVP Annex IV, ICH-E2C(R2) Guideline). 
It is the reference information by which listed and unlisted are determined for the purposes of periodic reporting for marketed products, but not by which expected and unexpected are determined for expedited reporting (GVP Annex IV, ICH-E2C(R2) Guideline).

Local or Regional Product Labeling/Information

Regulatory authority required product information intended to support the safe and effective use of a specific product that generally requires approval by the relevant Health Authorities (e.g., United States Full Prescribing Information [USPI], European Summary of Medicinal Product Characteristics [SmPC]) 
Local Product Labeling is the labeling approved by a single Health Authority for a single country. 
Regional Product Labeling is the labeling approved by a single Health Authority for multiple countries

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