The Trials and Tribulations of Managing and Updating the CCDS
Written by Gary Charbonneau, Vice President Global Regulatory Affairs at Allergan
The challenge of managing, updating, verifying, and reporting vast amounts of data is well understood in the pharmaceutical industry. One area where this challenge truly manifests itself is with the CCDS, or company core data sheet.
For those unfamiliar with the CCDS, this is a document created by a company that consolidates and summarizes the safety and efficacy data that a company believes to be a true and accurate representation of the data generated over the course of development. The CCDS usually starts life as the target product profile (TPP) while a product is in development. The TPP is the collection of company requirements captured during the pre-development phase that encapsulates what the company intends for that product to be. As the development phases are completed the aspirational TPP morphs into the CCDS and becomes an actual compilation of clinical, non-clinical, efficacy, and safety data.
The CCDS is vital information since companies use it to generate local country labels for a product. Needless to say, the CCDS is not linear, static, or comprehensive. It is intended to be globally applicable, but every health authority has its own requirements regarding labeling. Companies must be prepared to address those requirements, however, not all content changes for country-specific labeling will be present in the CCDS. For example, in negotiations with the local health authorities, companies could be asked to change the wording of certain text to reflect local requirements. These changes may not be globally relevant, and therefore, may not make it into the CCDS. Evaluation of the need for CCDS updates must be thoughtfully controlled. Plus, companies must ensure that concepts reflected in local labeling are in accordance with messaging in the CCDS.
When a company gets new safety data on its product -- for example, through the generation of post market data, or new adverse events – all country labels would be updated, and so would the CCDS. Companies will often have new clinical data when they’re studying that drug for either a new indication or to expand the indication, so again the CCDS is updated. Now it starts to get more complicated since companies not only must keep on top of the rules and regulations for updating their local labels, which can vary significantly from country to country, but must ensure they document and project manage all that information.
Content Crush
For companies with multiple products approved in multiple countries, this is a huge task. It requires maintaining a current CCDS for all products, oversight of country-level labeling to ensure consistency with CCDS concepts, evaluating the need for changes to the CCDS and country labels, and documenting the rationale for making, or not making changes. It involves keeping track of timelines from when changes are made to the CCDS, when a new proposed label is submitted to a health authority, and when a new label is approved by a health authority for implementation. It also includes ensuring that approved labeling gets onto the market (“in the box”) in accordance with local health authority-defined implementation timelines, which requires interaction with manufacturing and distribution functions. Furthermore, it means ensuring management awareness of every part of the labeling lifecycle, given the cross-functional implications of the process and the potential for conflicting opinions of health authorities regarding appropriate labeling content.
The reality is that no matter how good a company’s process is for managing the CCDS to local labeling lifecycle, few companies have a single system in place capable of end-to-end management and tracking. Most companies cobble together a workable solution with existing tools and process. While this approach is typical, it is far from ideal. New tools are necessary.
Increasingly, health authorities expect companies to be able to provide information that demonstrates appropriate oversight of the CCDS/labeling process. While most pharma companies can ultimately provide what is requested, the process of compiling the information is cumbersome, requiring multiple systems and data sources. What companies need is for the information to be centralized – not necessarily in terms of where it resides, but in terms of how it can be accessed from a single point. At its core is a comprehensive, reliable database simply containing the CCDS information and all local labeling for the company’s products. The process tracking piece can be developed once the core is in place.