5 Tips for Tracking Pharmaceutical Label Changes

When you revise a pharmaceutical label, you need a plan for tracking the change. Let’s examine why pharmaceutical label tracking is important and tips for making it more manageable.

Pharmaceutical Label Changes

The primary purpose of the pharmaceutical label is consumer safety. That’s why pharmaceutical labels include text and graphics that detail crucial, easily understandable information for practitioners, pharmacists, and consumers. In addition, regulators worldwide require comprehensive pharmaceutical labels, and pharmaceutical companies must provide labels that comply with regulations to market and sell their products. 

Making sense of regulatory compliance in a global environment takes work. Pharmaceutical labeling and tracking pharmaceutical labeling changes challenge companies because of their complexity and importance.

When Do You Need to Track Pharmaceutical Label Changes?

A pharmaceutical label core is a primary label that a company uses globally. When the drug goes to market, companies can make local labels from the core to meet the needs of local markets.

Labels can change due to the age of the product (newer products may have more changes than older products), or new market regulations could require an update. In addition, clinical studies, peer reviews, or studies on similar drugs can reveal new information concerning adverse reactions. Therefore, whenever there are pharmaceutical label changes, pharmaceutical companies must track and document them.

Tracking pharmaceutical label changes is a constant challenge, especially with an extensive product portfolio or if the frequency of changes is high. But without that tracking, labels can fall out of compliance, and you can’t sell your products. Therefore, we’ve come up with some tips to make tracking pharmaceutical label changes easier.

5 Tips for Tracking Pharmaceutical Label Changes

1. Differentiate Changes Based on Due Dates

No two regulatory agencies have the same timeframes for pharmaceutical label changes, but they prioritize similarly. Safety changes are urgent and must be shared with regulatory agencies faster than non-safety changes. Establishing a system to differentiate target dates for safety and non-safety changes can simplify tracking

2. Keep Track of Why a Change Was Implemented

Incomplete documentation could lead to compliance issues and other repercussions. That’s why it’s helpful to track why and when a change is made.

Consider this scenario: Your drug has gone through the review cycle, and a peer review indicates a change to the core label is necessary. The label is either updated or there needs to be an explanation for why it is not updated. If a country you market your medication in does not want that label change, the explanation provided by the country’s regulatory authority needs to be clearly documented. The reasoning behind this decision has to be tracked by your company, or you could get in trouble when it’s time for an audit.

3. Track When an Item Is Different on a Core Change

There are two types of label deviations: timeline deviations and content deviations. 

Timeline deviations refer to the due date of pharmaceutical label changes. You may be required to make a change in 60 days, but because of issues downstream in the process of making changes, you have to extend the deadline to 90 days. The fact that you have a timeline deviation needs to be documented, and the reason for the extension needs to be tracked.

Content deviations are changes in the content itself. So, for example, if the global core label says a drug causes your hair to turn blue, but a country wants the label to say the drug turns your hair blue-green, this requires you to document a content deviation for that country. 

Without documenting and explaining the reason for this change, your company could face an infraction. Such a content change needs to be explained in your company’s tracking system to ensure the company is compliant with the law.

4. Don’t Track Too Much at Once

While it may be tempting to track everything you possibly can, it’s better only to track the critical steps of your process. Too much detail will drain and overwork your resources, increasing the likelihood that crucial information will not be input, which has regulatory consequences.  It is better to track fewer key items and do them well than try to do everything and do it poorly.

5. Use Easy-to-Access Tracking Software

Audits can happen at any time. By using pharmaceutical label tracking software to keep the data simple and in a cohesive contained report, you make it easier for auditors to access the data they need to see, reducing their workload and your exposure.  Of course, this depends on the usability of your tracking software. Be sure to choose software that makes it easy for your company to provide auditors with complete, well-organized reports.

Tracking software supports your efforts to remain compliant. Pharmaceutical labeling changes in artwork, local product documents, or the core label in an environment with many deadlines, differing countries, printing, supply chain issues, and more without a robust system in place can cause delays in timelines and can lead to compliance issues.


Pharmaceutical label tracking is complex. However, following these five tips for tracking pharmaceutical label changes can keep all stakeholders informed of the process, maintain the documentation needed by regulatory agencies around the world, and reduce your company’s risk.

Tracking Portal by Intagras is regulatory tracking software that takes the guesswork out of pharmaceutical label tracking. Contact us to learn more.

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