Getting an Early Start: Taking a Holistic Approach to Product Labeling

When pharmaceutical companies think about labeling, the assumption is that it begins with the marketed product. So the focus has typically been on managing the labeling text for post-marketing activities — artwork, packaging, etc.

But it’s during the clinical trial phase that the company core data sheet (CCDS) should be developed and then updated periodically, but certainly once phase 3 trials are completed. Since the CCDS forms the foundation for product labeling and supports the company’s core safety information, it makes sense to start thinking about labeling much earlier than has historically been the case.

From the start, if you can step back and begin to identify and capture information that will be required in the labeling text, it will help as you move through the various stages and toward regulatory submissions.

Begin with Discovery

It’s at the discovery stage that the labeling details start to emerge. The category of Chemistry, Manufacturing and Controls (CMC) is key to product and substance specifications and generates data that ultimately will be important in clinical trials — as well as labeling and packaging.

Labeling also plays an important role in the supply chain, including during the clinical and nonclinical phases when substances are shipped to different sites or to the lab. All that information is part of labeling, since it’s required on the package. For example, during nonclinical or animal studies, information about what is being shipped must be identified, and requirements for labeling become more stringent once clinical studies get under way and products are being tested in humans. This is especially true regarding the Material Safety Data Sheet (MSDS) regulations.

Clearly, data will change a bit during the course of product development, but if you start thinking about labeling earlier and take a more holistic approach to managing the data that will become important for your labeling text, it becomes easier in pre- and post-marketing activities.

Interestingly, this is one area where the device industry is ahead of pharmaceuticals. Although device companies are generally considered to lag behind the pharma industry on electronic submission activities, when it comes to labeling, they’re taking the lead. That’s because device companies are required to solidify a significant portion of the label content before starting clinical trials and have therefore had to improve their processes early on.

Ultimately, taking a holistic approach to labeling — from discovery through to post-marketing — will ensure better cross-functional visibility among supply chain, manufacturing, CMC, labeling, regulatory and pharmacovigilance.

Learn more about managing labeling text and the value of cross-functional visibility by downloading the CSC white paper, “Connecting the Dots Across the Labeling Life Cycle.”


Diane Gross is a senior professional in Life Sciences Regulatory Consulting at DXC.


From Branded to Generic – Staying on Top of Labeling Changes

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