Pharmaceutical Labeling

Pharmaceutical labeling is a critical function for any pharma company. But why is it so challenging to track on a global scale? In this post, we cover everything you need to know.

Pharmaceutical Labeling

Pharmaceutical labels are mandatory for marketing and selling a drug. But requirements are strict. And they often vary, and change, based on when and where a drug is being brought to market. Thus, it is critical for pharma companies to have a reliable way to track every difference and change, all around the world.

Without it, your labels will fall out of compliance. And your drug or drug-containing products cannot be sold.

What is a Pharmaceutical Label?

A pharmaceutical label includes the text or graphics that are written or printed on any drug or drug container. Its intent is to offer information about a drug’s contents and provide instructions or warnings about administering, storing and disposing of the drug. The Food and Drug Administration (FDA) requires all pharmaceutical labels to include:

Why Is It Mandatory?

The FDA makes pharmaceutical labels mandatory in order to keep patients safe, especially those who are older. Nearly 9 in 10 (89%) adults 65 and older take some kind of prescription medicine. But until 2002, there were no established guidelines for pharmaceutical labels, so the placement and legibility of important drug information varied. This was dangerous, as patients could easily miss the warnings and side effects that were printed on the label. As a result, the FDA regulated pharmaceutical labels to make them easier to comprehend. Now, all labels have a standard label format that includes clear statement language.

What is Pharmaceutical Labeling?

If you’re here, you know what a pharmaceutical label is – at least the basics. The practice of gathering and disseminating all the data on that label – active ingredients, purpose and use, warnings, directions – and submitting it to regulatory authorities is known as pharmaceutical labeling. The goal is to prove, through research and testing, that a drug has efficacy across a population – that it works and that there is some advantage to taking it.

There are many items that get submitted to regulators to support the facts and findings of a given product’s testing and trials, including:

There are many items that get submitted to regulators to support the facts and findings of a given product’s testing and trials, including:

  • What was discovered.
  • What was tried in terms of dosage.
  • Interactions.
  • The process by which you create the label.
  • The process by which you get approval.
  • The process by which you negotiate.

Where is Pharmaceutical Labeling Required?

While there is no global pharmaceutical labeling standard, each market has its own authority that approves labels before the drugs come to market. The most well-known include:

All pharmaceutical labels are based on cores – the label that companies use on a global level. From there, the core label can be changed to suit specific market needs, creating local labels.

Why is Pharmaceutical Labeling Important?

Pharma companies are required to submit labeling documentation to begin or to continue selling a pharmaceutical product in a specific market. 

In the United States, the Food and Drug Administration (FDA) uses those labels and findings to set standards known as Precision Labeling Reference (PLR). Every label needs a section for the dosage, packaging, adverse reactions, pharmacokinetics and more. That template and the labeling process are the common ground for how you negotiate and get approval. This is important because there is nothing the regulatory authority can approve without the label.

So, now that we’re up to speed on what labeling involves and why it’s so important, let’s dive into the practice of label tracking.

The Challenges of Label Tracking

In the simplest of terms, label tracking exists because labels change. And they do so for a variety of reasons. For example, if research shows an adverse reaction to a drug but it isn’t mentioned on the label, the label must be updated.

Every change requires a new submission to regulators – in every market a product is sold. Pharma companies must track these submissions closely so they can resolve any resulting issues at once. Otherwise, their product will be pulled. 

But tracking changes can be challenging, especially outside your home market.

It’s common for pharma companies to submit changes to multiple regulatory authorities at the same time because it saves time. But keeping up with the status of so many changes can be difficult. Every regulatory body processes changes differently. 

Even in countries where things are more refined, pharma companies often must call to find out the status of a change. This gets exceedingly more difficult in non-local regions because there are more entities to contact and more changes to track.

The good news is there’s an easier solution.

Using Label Tracking Software

Global tracking software helps pharma companies organize much of the manual aspect of label tracking into a streamlined form. So, everything from label creation to regulatory submission to regional tracking can be managed in less time and with fewer people needing to be involved. To understand the full impact, let’s look at the basic pharma labeling process.

There are three main phases of pharmaceutical labeling:

  1. Creating and submitting the label
  2. Establishing the artwork
  3. Manufacturing

The teams that work on each phase are often siloed and use separate systems, making it hard to track overall progress. Tracking software solves this by aggregating submission data from each system in real time and then sharing it with everyone involved. So, no matter which department or phase you’re working on, you can see how changes and submissions evolve globally.

This makes it easier to make strategic decisions and ask key questions, such as:

  • How long does it take to implement a label change in a certain country?
  • Is a country’s regulatory authority faster than others?
  • Is a lengthier change due to a resource constraint?

While standards vary across countries, all regulatory authorities have submissions, approvals, negotiations, and deadlines. With tracking software helping your team stay organized, you can keep up with every change, regardless of where you are in the world.


Tracking changes to pharmaceutical labels is a complex process – one that companies can’t handle manually. Tracking software is instrumental in giving you an overview of your data so you can make improvements to your processes.

Intagras offers a state-of-the-art regulatory tracking solution, Tracking Portal, that allows pharmaceutical companies to track changes to labels in every country their drugs are marketed. Tracking Portal gives you the inside track on what’s happening in real-time, so you can understand what it means to your organization – and then act on it. Contact us to learn more.

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Have questions about our tools or service? Talk to one of our experts or request a demo of our Tracking or SPL Portal software today.