Long-Term studies

    Postmarket Safety Surveillance

    Ensuring the safety and regulatory compliance of smoke-free products is a top priority at Philip Morris International (PMI). Postmarket safety surveillance is part of a comprehensive approach to regulatory compliance and responsible commercialization of our products. Following market introduction, we monitor the safety profile of smoke-free products to detect and address any potential new or different health risks associated with product use.

    What is postmarket safety surveillance?

    While premarket approvals assess safety before product release, postmarket surveillance is vital for ongoing monitoring of safety concerns and is an important building block 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.”

    Postmarket safety surveillance at PMI

    At PMI, the safety and regulatory compliance of our smoke-free products is paramount. The goals of our postmarket safety surveillance include understanding the benefit/risk profile of our products, implementing measures to minimize risks to consumers, and complying with local regulations. Postmarket surveillance also contributes to the data obtained during clinical trials and other studies.

    Postmarket safety surveillance is an integral part of our comprehensive assessment program, 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). This ensures our processes are as robust as possible when conducting clinical research and postmarket studies. Our surveillance program also complies with the U.S. Tobacco Control Act.

     

    Collection and management of safety data

    We have the responsibility of reporting adverse events (AEs). These are any unfavorable health-related incidents that occur during product use, regardless of whether a causal relationship has been established. AEs associated with new safety information and product quality issues, which meet regulatory criteria for seriousness, are collected worldwide through various channels. All AEs are processed and recorded in a GVP-compliant database.

    Our safety team collects and analyzes reports to identify potential AEs associated, or potentially associated, with our smoke-free products. To do this, we use multiple input channels, including:

    • Call centers
    • Poison centers
    • Social media
    • Clinical studies
    • Literature screenings

    The safety reports detailing AEs associated with the use of any PMI product 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 seriousness are promptly reported to the appropriate authorities in compliance with local laws. We also effectively communicate the results of our safety surveillance efforts to customers through safety warnings and instructions and via our call centers.

    We conduct systematic analyses of aggregated reports to uncover emerging trends and potential risks, thereby facilitating the timely identification of safety signals. Our scientists 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 modified risk tobacco product (MRTP) applications.

    The role of postmarket safety surveillance in supporting PMI’s MRTP application

    PMI established a safety surveillance system in concomitance with the initial launch of our Tobacco Heating System (THS), commercialized as IQOS. In addition to the collection and reporting of adverse incidents, aggregate data analyses, including signal detection activities, are performed to ensure prompt identification of risks and communication with relevant parties. 

    On 7 July 2020, the FDA authorized the marketing of IQOS as an MRTP with reduced exposure claims. To reach a decision to authorize marketing of a proposed MRTP under section 911 of the Federal Food, Drug, and Cosmetic (FD&C) Act, the FDA must consider:

    1. The relative health risks to individuals of the tobacco product
    2. The increased or decreased likelihood that existing users of tobacco products who would otherwise stop using such products will switch to the tobacco product
    3. The increased or decreased likelihood that people who do not use tobacco products will start using the tobacco product
    4. The risks and benefits to people from the use of the tobacco product as compared with the use of products for smoking cessation approved as medical products to treat nicotine dependence
    5. Comments, data, and information submitted by interested persons

    Postmarket safety surveillance plays an important role in this process, contributing data on points 1, 4, and 5 above.

    Safety surveillance of THS

    Between the commercial launch of THS in November 2014 and December 31, 2023, postmarket data have shown a steady safety profile for THS products. At the same time, the number of users has increased from fewer than 5,000 to more than 30 million. Over this period, most of the AEs assessed were nonserious, with only 2.29% of cases meeting the seriousness criteria. The most frequently reported AEs are shown in the graph below.

     

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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. 

    PMIScience.com is operated by Philip Morris International for the purpose of publishing and disseminating scientific information about Philip Morris International’s efforts in support of its smoke-free product portfolio. This site is a global site for use by scientists, the public health and regulatory communities, and other stakeholders with an interest in tobacco policy. The purpose of this site is not advertising or marketing, nor is it directed at any specific market. It is not intended for use by consumers. New tobacco products sold in the United States are subject to FDA regulation; therefore the content of this site is not intended to make, and nor should it be construed as making, any product related claims in the United States without proper FDA authorization. ​
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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.