Our Commitment
Over the past five years we have been on a transformative journey – building upon existing post-market surveillance processes and establishing a dedicated Product Vigilance Centre of Excellence. We have proactively expanded our expertise and resources, to strengthen our overall operation and amplify the value we deliver.
‘Doing the Right Thing’
Our ambition in Product Vigilance is integral to BAT’s vision of Building a Smokeless World, by supporting the development and stewardship of innovative alternatives that meet product standards and are responsibly monitored. As these new product categories represent a critical shift away from traditional combustibles, our resources dedicated to post-launch monitoring have grown increasingly important.
We receive reports of adverse events associated with our Smokeless Products from our consumers, clinical research and consumer research participants worldwide. Our products are rigorously developed and tested to high standards, and our Product Vigilance efforts reflect the same high standards.
Once a product is in market, ongoing post-market surveillance should be standard for all responsible manufacturers.
Fulfilment of Expectations
Stakeholders and regulators expect accurate data collection and management, and we take this responsibility seriously. Each consumer report is reviewed by multiple subject matter experts to allow the correct triage and an accurate assessment. High importance is placed on actively listening to feedback and turning insight into action where needed.
By heightening our standards and focus on adverse event management, we can better support product improvements and ensure stable risk profiles while also reducing the likelihood of misuse. This all equates to delivering reputable products for adult smokers seeking smokeless alternatives to continued smoking.
“An ethically grounded practice that ensures we remain vigilant stewards of our products.”
Hugo Tan
Global Medical Safety Officer
The North Star in Product Vigilance
While the overwhelming majority of our Smokeless Products are not licensed medicinal products, we look to the pharmaceutical industry as inspiration for post-market surveillance, guiding the evolution of our programme. Core pharmacovigilance principles – structured quality monitoring, adverse event management, and reporting, are critical to the approach. Our primary reference is the European Medicines Agency’s Good Vigilance Practices (GVP), which serves as our regulatory framework and North Star.
At the heart of our operation is a pharmaceutical-grade specialised vigilance database (PV database) housing BAT’s adverse event data. Each AE is processed through a bespoke case workflow, inspired by pharmaceutical industry standards. We have adopted MedDRA* coding to standardise the dictionary of terms used for coding adverse events.
Certain products, dependent upon the market and regulatory regime, require vigilance reporting. This may require reporting of individual events that meet specific criteria to regulatory authorities or the preparation of annual summary reports – requirements enabled by these principles.
While inspired by pharma, our standards are tailored and appropriate for the tobacco and nicotine product categories. Rather than replicating the model, we have built upon these well-established foundations to create a framework that is fit-for-purpose and aligned with regulatory expectations for our product categories.
The following pages of this chapter outline key components of this framework supporting BAT’s vigilance programme.
Footnotes
* MedDRA – Medical Dictionary for Regulatory Activities, developed by the International Council for Harmonisation (ICH).
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