Ensuring the safety and regulatory compliance of smoke-free products is a top priority at Philip Morris International (PMI). Post-market safety surveillance is part of a comprehensive approach to regulatory compliance and responsible commercialization of our products. We monitor the safety profile of smoke-free products post-market to detect and address any potential new or different health risks associated with product use.
Post-market safety surveillance is an important building block in the assessment of smoke-free products. The U.S. Food and Drug Administration (FDA) defines it as “the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device.” While pre-market approvals assess safety before product release, post-market surveillance is vital for ongoing monitoring of safety concerns.
For us at PMI, the safety and regulatory compliance of our smoke-free products is critical. Our goal is to understand the benefit/risk profile of our products, implement measures to minimize risks to consumers, and comply with local regulations. Post-market surveillance also contributes to the data obtained during clinical trials, post-market trials, and other studies.
At PMI, we follow pharmaceutical standards for safety surveillance inspired by EU Good Pharmacovigilance Practices (GVP) for drugs to ensure our processes are as robust as possible when conducting clinical research and post-market studies. Our surveillance program also complies with the U.S. Tobacco Control Act.
We have the responsibility of reporting adverse events (AEs), AEs associated with product quality issues, and new safety information, that meet the regulatory criteria for seriousness. Regulatory agencies play a vital role in evaluating safety data and ensuring necessary actions to mitigate risks. Post-market safety surveillance is an integral part of our comprehensive assessment program, ensuring that safety considerations are taken into consideration throughout the product lifecycle.
On 7 July 2020, the U.S. FDA authorized the marketing of the IQOS tobacco heating system as a modified risk tobacco product (MRTP) with reduced exposure modification order. To reach a decision to authorize marketing of a proposed MRTP under section 911 of the Federal Food, Drug, and Cosmetic (FD&C) Act, U.S. FDA must consider:
Post-market safety surveillance contributes to the points 1, 4, and 5 above.
Our safety expert team collects and analyzes reports to identify potential AEs associated, or potentially associated, with our smoke-free products through multiple input channels:
The safety reports of AEs associated with the use of any product worldwide are processed and assessed by our safety expert team. Each individual report undergoes internal review based on the medical team’s judgment, 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 analyze aggregated reports to detect emerging trends and potential risks, enabling us to identify safety signals. Our scientists support regulatory submissions, including Premarket Tobacco Product Application (PMTA), MRTPs and compile Safety Update Reports (SURs) based on these analyses. Annually, we communicate these reports to regulatory authorities.
We effectively communicate the results of our safety surveillance efforts to customers through Safety Warnings and Instructions (SWI) and via our call centers.
