Long-Term studies

Postmarket Safety Surveillance at Philip Morris International

Ensuring the safety and regulatory compliance of smoke-free products is a top priority at Philip Morris International (PMI). Simultaneous to the launch of the very first Tobacco Heating System (THS), commercialized as IQOS, PMI established a worldwide postmarket safety surveillance system. Learn how this system collects and analyzes real-world, health-related events for THS and how this information is used to detect and address any potential new or different health risks associated with THS use.

What is postmarket safety surveillance?

While premarket authorizations assess safety before product release, postmarket safety surveillance is vital for ongoing monitoring of safety concerns and is a key step in the assessment of smoke-free products. Regulatory agencies also play a vital role in evaluating safety data and ensuring necessary actions to mitigate risks. The U.S. Food and Drug Administration (FDA) defines postmarket surveillance as “… the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device.” 

At PMI, the safety and regulatory compliance of our smoke-free products is paramount. The goals of our postmarket safety surveillance include understanding the benefits and risk profile of our products, implementing measures to minimize risks to consumers, complying with local regulation, and ensuring that safety is taken into consideration throughout the entire product lifecycle.  

PMI conducts its safety surveillance in alignment with pharmaceutical standards inspired by EU Good Pharmacovigilance Practices (GVP), strengthening the robustness of our processes for clinical and postmarket research. Our surveillance system also complies with the U.S. Tobacco Control Act and the FDA's draft guidance for modified risk tobacco product (MRTP) applications. 

Find out more about PMI's safety surveillance system here.

What is an adverse event?

The FDA has defined an adverse event (AE) in its draft guidance for MRTP applications as “… any health-related event associated with the use of a tobacco product in humans that is adverse or unfavorable, whether or not it is considered tobacco-product related.”  

Examples of AEs may include:   

  • Nausea after product use  
  • Burning sensation from device overheating  
  • Increased incidence of coughing following product use 

Solely product-related incidents, such as the blade in the device breaking, are not considered AEs, as they are not health-related. 

How does PMI collect safety surveillance information on AEs?  

PMI’s safety surveillance takes into account the relevant regulations, standards, and guidelines mandated in the countries where our products are commercialized. 

PMI collects health-related events worldwide from a number of different channels, including:  

  • Call centers staffed with agents trained in collection of information on AEs 
  • Social media  
  • National poison control centers  
  • Scientific literature  
  • Local market campaigns and surveys  
  • Corporate website  
  • Market research studies 

The information collected includes, at a minimum, the event (headache, cough, nausea, etc.), product involved, country, gender, and age of the reporter. Events are categorized by seriousness following the International Council for Harmonization’s (ICH’s) criteria regarding clinical standards for safe data management and the European Medicines Agency (EMA) list for the definition of important medical events. 

According to these criteria, a serious AE is one which could result in one or more of the following: 

  • Inpatient hospitalization or prolongation of existing hospitalization 
  • Persistent or significant disability/ incapacity 
  • Congenital anomaly/birth defects 
  • Threat to life 
  • Death 
  • Assessment as an important medical event 

Safety reports detailing AEs associated with the use of PMI smoke-free products worldwide are processed and assessed by our trained safety team. Each individual report undergoes internal review, allowing us to carefully evaluate its significance. AEs meeting regulatory criteria for submission are promptly reported to the appropriate authorities, in compliance with local requirements. We communicate the results of our safety surveillance efforts to consumers through channels such as safety warnings and product instructions. 

In addition to the collection and reporting of AEs, aggregate data analyses, including signal detection activities, are performed to ensure prompt identification of potential risks. 

Our scientists also compile safety update reports based on these analyses. These reports are communicated annually to regulatory authorities and support regulatory submissions, including premarket tobacco product applications (PMTAs) and MRTP applications. 

How does PMI identify and respond to safety issues?

PMI conducts signal detection activities to identify potential or emerging safety issues. A signal refers to information that suggests a new, potentially causal association—or a new aspect of a known association—between a product and an AE or a set of related AEs. Signals may point to either a potential or an identified risk. A potential risk is an AE that may be linked to the product, but where the evidence is not yet conclusive. In contrast, an identified risk is one for which there is sufficient evidence to confirm a causal relationship with the product. 

PMI’s signal detection process has five steps, including detection, validation and prioritization, assessment, recommendation for actions, and risk communication. 

For example, signal detection may begin when consumers contact a call center to report a potential AE. The signal then undergoes the validation step, where additional information is gathered to determine its substantiation.  

Signal assessment can then take place. This may include literature or ad hoc laboratory research to investigate the cause of the signal. Once a cause is scientifically determined, safety actions and mitigation measures can be taken. These can include changes to the product, additional safety warnings or changes to existing warnings, and/or regulatory notifications.  

 

Conclusion

With the commercial launch of THS in 2014, PMI was the first tobacco company to establish a postmarket safety surveillance system in concomitance with the launch of a new product. By 2024, this system was available in more than 80 countries and included more than 4,000 call center agents trained to collect information on AEs. The system covers multiple sources of data collection, case processing within the safety database, and individual submissions to authorities.  

PMI’s aggregate data analysis and signal detection activities enable rapid identification of potential risks. From November 2014 up to the end of 2024—the most recent period for which data is available—these analyses have shown a consistent safety profile for THS. PMI will continue to collect and evaluate safety information to support ongoing monitoring of the safety profile of THS.

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Long-term safety surveillance with Tobacco Heating System

Simultaneous to the launch of the very first Tobacco Heating System (THS), commercialized as IQOS, Philip Morris International (PMI) established a worldwide postmarket safety surveillance system. 
From data collection to global impact: An interview with Philip Morris International’s safety surveillance team
Philip Morris International (PMI) has a robust and state-of-the-art postmarket safety surveillance system in place.

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Reduced Risk Products ("RRPs”) is the term we use to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continuing smoking. PMI has a range of RRPs in various stages of development, scientific assessment and commercialization. All of our RRPs are smoke-free products that deliver nicotine with far lower quantities of harmful and potentially harmful constituents than found in cigarette smoke.