Overview

As a critical aspect of product lifecycle management, labeling is one of the complex processes of life sciences’ Regulatory environment. Due to constantly evolving Regulatory requirements, organizations must ensure that the product information related to manufacturing, safety and efficacy, mentioned on the labels, is controlled by maintaining a central or core reference product information.

A core label (CDS-Core Data Sheet) is an internal Regulatory document which serves as the company’s global reference document for a product. It is used to communicate the company’s position to appropriate stakeholders worldwide for the inclusion of safety and efficacy information on country-specific labels. A Core label is either prepared before or after the Regulatory approval (or another Regulatory pathway), in order to market a medicinal product worldwide.

The primary information of a Core label is derived from the Investigator Brochure (IB) of a clinical trial and then continually revised by adding more information from Post-marketing sources like Post-marketing safety and efficacy studies and Post Marketing Surveillance data.

The Company Core Data Sheet (CCDS) may also be used as an attachment to a Periodic Safety Update Report (PSUR).  In this context, all the safety information mentioned in a CCDS ("Company Core Safety Information" or "CCSI"), or a specifically identified (e.g. by bold print) subset of this safety information, serves as reference information for determining "listedness".

The CIOMS III/V and VI guidelines describe some general criteria regarding the inclusion of safety information in a CCDS/CCSI. However, labeling regulations, guidelines and expectations have significantly changed and have become more specific since the CIOMS III and III/V reports were published. Taking these developments into account is crucial from a Regulatory and legal/litigation point of view. Equally important for the Regulatory viability and defensibility of CCDS and CCSI content, and for labeling harmonization are carefully drafted and effective rationales as well as supporting documentation (Clinical Overviews).

Freyr’s unique experience in the field of labeling, and Core labeling in particular, makes it an ideal resource for companies that create or revise CCDS and CCSI and harmonize local safety labeling. Freyr’s experienced labeling team not only tracks the country-specific labeling standards for timely implementation of the labeling changes, but also provides cost-effective global labeling consultation.

 

Freyr Expertise

  • Create, review and update Investigational Brochure (IB)
  • Create, review and update Developmental Core Data Sheet (DCDS)
  • Create, review and update Company Core Data Sheet (CCDS)/Reference Safety Information (RSI)
  • Detailed literature search & review to substantiate labeling content
  • Create, review and update Clinical Overviews (CO)/Justification documents (JD)
  • Quality Check (QC) of Core labels (IB, DCDS, CCDS, RSI, CO/JD)
  • Tracking and implementation of labeling Changes  
  • Label Content Change Control Management
  • HA query Management 
 

Freyr Advantages

  • Resources with in-depth Regulatory knowledge
  • Expertise in successfully handling global and regional drug labeling for Fortune Pharma clients, worldwide
  • Extensive global experience covering diverse Regulatory domains across Pharma
  • Highly qualified medical writers possessing extensive Regulatory experience
  • In-depth and updated understanding of the global drug labeling changes, as required by local Regulatory authority bodies
  • Dedicated compliance team tracking the status of data sheets implementation in regional labels
  • Highly experienced labeling professionals