Connecting the Dots Across the Labeling Life Cycle
Faced with a rigorous regulatory environment and heightened business demands, life sciences companies are under continual pressure to better manage their labeling to reduce errors, avoid misbranding, improve consistency and gain efficiencies. Labeling content is subject to constant change, whether because of product development, mergers and acquisitions (M&A), regulations, regional differences, product updates or safety findings. Failure to act quickly and accurately puts companies at risk of noncompliance, which can result in fines and damage to the brand as well as to the organization.
The labeling text in the regulatory space, also referred to as the prescribing information or package insert (PI), includes the approved uses of the product as well as instructions for use, along with warning details that coincide with information necessary to ensure the drug is used safely and effectively. This extends to all the data and statistics on adverse events, findings from clinical trials, and manufacturing specifications. Labeling text should be derived from the company core data sheet (CCDS), the approved internal source document that is the basis for product, labeling, artwork, packaging and promotional materials.
There are significant business complexities with regard to managing labeling text. One of the most critical aspects is creating and managing the CCDS, which must account for all product information of commercial relevance to the company in addition to all Health Authority (HA) labeling requirements across regions. Organizations also often experience significant difficulty in tracking and capturing the reasons for any deviations that may exist between the content in local submission documents (e.g., Summary of Product Characteristics [SmPC]) and the content in the CCDS. Given the global nature of pharmaceutical products, companies must be able to respond quickly and accurately to regional mandates and changes.
In this multifaceted, highly regulated and global environment, life sciences companies need to adopt processes and solutions that will enable them to respond rapidly to change and achieve actionable insights across the entire labeling life cycle. This will result in improved regulatory operations as well as enhanced collaboration with all relevant stakeholders — regulatory, manufacturing, marketing and legal.
A strategic, enterprise-wide approach to labeling — where content, including the CCDS, can be easily shared and updated — will help deliver multiple benefits to companies and drive value across the following five business scenarios.