Overview

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

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

The primary information of a core label is derived from the Investigator Brochure (IB) of a clinical trial. Furthermore, the core labeling document is 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 (CCSI)) or a specifically identified (e.g., by bold print) subset of this safety information, serves as reference information for determining the "listedness".

The CIOMS III/V and VI guidelines describe some general criteria regarding the inclusion of safety information in a CCDS/CCSI. However, the 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 global labeling harmonization, are carefully drafted and effective rationales as well as supporting documentation (Clinical Overviews).

Freyr’s unique experience in the field of Regulatory labeling, and specifically core labeling, makes it an ideal resource for companies that create or revise CCDS and CCSI, and harmonize local safety labeling. Freyr has expertise in the preparation of label justification documents and global deviation management to enable clients to remain prepared for any deviations in the result. Freyr’s experienced labeling team not only tracks country-specific labeling standards for on-time implementation of the Regulatory labeling changes but also provides cost-effective global labeling management consultation.