Pharmaceutical Label Tracking

Pharmaceutical label tracking helps to ensure that only the highest quality drugs are produced and distributed to the public. Pharmaceutical companies utilize tracking to monitor label changes.

Pharmaceutical Label Tracking

What Is Pharmaceutical Regulatory Tracking?

Pharmaceutical regulatory tracking is the process of monitoring and managing changes to drugs. When a pharmaceutical label requires a change, companies must revise the label and resubmit it to all the regulatory authorities of the markets where the drug is marketed. From there, pharmaceutical companies use software to track the progress of the submissions.

What Is Regulatory Compliance in Pharmacy?

Regulatory compliance in pharmacy involves

  • Keeping track of the current regulations.
  • Identifying potential changes.
  • Preparing products in accordance with the new regulations.

It is important to ensure that the products are being manufactured and distributed in compliance with the relevant regulatory requirements.

Every market has its own regulatory authority. Examples of regulatory authorities include

What Are Pharmaceutical Labeling Deviations?

Pharmaceutical labeling deviations refer to any changes that a market makes that are not what was originally proposed by the global regulatory team.

Examples of these deviations include changes to the color, font size, graphics, text, symbols, or other visual elements of the labeling. These deviations may lead to confusion for healthcare providers, patients, and other stakeholders in your market, so it’s important to ensure that the labeling changes are in compliance with the regulatory requirements.

Two main types of variations are content and timeline deviations.

What Is a Content Deviation?

A content deviation is when the actual content of the product doesn’t match what’s stated in the drug’s Company Core Data Sheet (CCDS) or Core Data Sheet (CDS). The CCDS is an internal document owned by the marketing authorization holder (MAH), and it’s updated throughout the entire drug lifecycle. That way, the document contains the most up-to-date information.

Content deviations can occur due to errors in production, incorrect labeling, or other reasons. Therefore, it’s important to ensure that all pharmaceutical labels are accurate to ensure patient safety.

Content deviations can be planned or unplanned. For example, a planned deviation can happen when the CCDS says a drug may turn hair blue. A local authority can purposefully change the wording to say the drug can turn your hair blue/green. Unplanned deviations can involve incorrect dosages, ingredients, or any other information listed on the label.

What Is a Timeline Deviation?

A timeline deviation happens when a pharmaceutical company, market, or other stakeholders cannot meet its defined SOP for a specific step in the SPL submission process.

For example, when a regulatory authority has approved a revised CCDS for a safety change, a dependent market (like Costa Rica) has 30 days to submit the updated local document to its health authority (the Ministry of Health). If the local market can’t do this within 30 days, it can request a timeline deviation, so it has more time to submit its updated local label.

What Is a Pharmacovigilance System Master File (PSMF)?

A pharmacovigilance system master file (PSMF) is a document that contains all of the necessary information about a company’s pharmacovigilance systems, including the systems’

  • Organizational structure.
  • Responsibilities of personnel.
  • Processes.
  • Quality assurance procedures.

The regulatory authority uses the PSMF to evaluate the effectiveness and compliance of the pharmacovigilance systems in place. Therefore, the PSMF should be kept up-to-date and reflect any changes or modifications to the pharmacovigilance system.

The European Union (EU) requires any pharmaceutical company that wants to market drugs in its market to apply for marketing authorization (MA). And the regulatory authority for the EU, the EMA, requires all MA applications to include a PSMF. So the PSMF plays an integral role in marketing drugs in the EU.

What Are Pharmaceutical Labeling Safety Signals?

A pharmaceutical labeling safety signal, also known as a safety change, is an alert sent by a pharmaceutical company to regulatory authorities. This happens when the company’s drug or medication has an undocumented adverse event that needs to be made known as soon as possible.

For example, if a drug causes seizures, but that warning is absent from the drug label, the pharmaceutical company must send a safety signal to every regulatory authority the drug is marketed. That way, the regulatory authority can alert all prescribers, pharmacists, and patients of the potential side effect. In the meantime, the pharmaceutical company works to update its label.

How Do You Identify Pharmacovigilance Signals?

The process of identifying pharmacovigilance signals is called signal detection. It involves collecting, analyzing, and interpreting data from multiple sources to identify potential safety issues with medicinal products. This includes collecting data from clinical trials and post-marketing surveillance, assessing the risk of adverse events, and analyzing trends in product use.

The purpose of signal detection is to identify potential safety signals early and take appropriate action to mitigate risks to patients.

What Are Pharmaceutical Labeling Dependencies?

Pharmaceutical labeling dependencies are circumstances where one market’s label needs information from another market before it can start working. The most common example is when a country needs to submit a label change, but it needs more information before it can submit. 

In many cases, this involves a country whose regulatory body does not do this line of work. That makes the country dependent. However, the dependent country can utilize work completed by a reference country to keep the project moving along.

For example, Costa Rica may wait for another country, like the United States, to approve a drug before it begins its own approval process. Once the United States approves it, Costa Rica will follow along.

What Is Pharmaceutical Regulatory Tracking Software?

Pharmaceutical regulatory tracking software is a type of solution that helps pharmaceutical companies streamline the process of submitting documents to regulatory agencies, tracking the progress of approvals, and managing the associated data. It shows companies what’s happening in real time so they can react promptly and stay in compliance.


Pharmaceutical label tracking empowers pharmaceutical companies to keep track of label changes all around the world. This helps to ensure the safety, efficacy, and quality of drugs.

Intagras provides a best-of-breed regulatory tracking solution, Tracking Portal, that enables pharmaceutical companies to manage label changes in real time. Tracking Portal breaks down siloes and helps all teams work together to keep label changes on track and keep patients safe. Contact us to learn more.

Need label tracking help? Talk to us.

Have questions? Need more info? Talk to one of our experts or request a demo of our Tracking Portal today.