Pharmaceutical regulatory tracking is the process of monitoring label changes. The purpose is for pharmaceutical companies to keep tabs on the progress of their label changes after they are submitted to the regulatory authorities in which they want to market their drugs.

Pharmaceutical labeling deviations are a list of deviations applied to a drug label. Deviations are the quantified differences between what a drug is expected to do compared to the documented standards. There are two types of deviations: content and timeline.

A content deviation occurs when a local label deviates from the wording in the drug’s Company Core Data Sheet (CCDS). For example, the CCDS may state that the drug may turn your hair blue, while the local authority may want wording stating your hair can turn blue/green.

A timeline deviation occurs when a company can’t meet its defined SOP for a given step in the submission process. For example, once an updated CCDS has been approved for a safety change, a market has 30 days to submit the updated local document to their health authority. If the 30 days can’t be met, the local market could ask for a timeline deviation that would extend the number of days needed to submit their updated local label.

A pharmacovigilance system master file (PSMF) is a document detailing the pharmacovigilance system for a drug. If a pharmaceutical company wants to market drugs in the European Union (EU), it must apply for marketing authorization (MA). The regulatory authority for the EU, the European Medicines Agency (EMA), requires all MA applications to include a PSMF.

A pharmaceutical labeling safety signal, or safety change, is an alert that a pharmaceutical company sends to regulatory authorities when there is an undocumented adverse event to its drug. For example, if a drug causes health problems, but that warning isn’t on the drug label, the pharmaceutical company must alert the regulatory authority of the country in which the drug is marketed. The goal is to make the regulatory authority aware of the situation so the drug label can be updated accordingly.

The process of identifying pharmacovigilance signals is called signal detection. With signal detection, a pharmaceutical company looks for and finds safety signals from various sources. Pharmaceutical companies are required to have reporting systems in place to keep track of any reports of adverse events to their drugs.

Pharmaceutical labeling dependencies occur when one market’s label needs information from a different market before it can begin work. This typically happens when a country needs to submit a label change and relies on other pieces of information before it can submit. Most of the time, this involves a country that does not have its own regulatory body to do this line of work. The dependent country can leverage the work already performed by its reference country. For example, Costa Rica may wait for another country, like the United States, to approve a drug. Once the United States approves it, Costa Rica will follow along. In other cases, this could be waiting for a translation of the core datasheet into a different language.

Pharmaceutical regulatory tracking software is a solution that helps pharmaceutical companies monitor label changes in the markets they submit to. This includes everything from label creation to regulatory submission to regional tracking. Since pharmaceutical labeling teams are often siloed, tracking software makes it easier to track overall progress by aggregating submission data from each system in real time and then sharing it with everyone involved.