Broughton Director of Product Safety and Compliance, Yvonne Wilding, discusses a leading-edge software tool designed and in use at Broughton to assist with toxicological screening and risk...
Post Market Requirements - A journey, not a destination
Oct 16, 2020 | Published by Yvonne Wilding
Broughton , Director of Product Safety and Compliance, Yvonne Wilding has recently published an article with leading sector publication Tobacco Reporter.
Yvonne discusses navigating successful post-market requirements for ENDS products and why it is a journey, not a destination.
A journey, not a destination
Last month marked the deadline for submitting premarket tobacco product applications (PMTA), many companies are waiting for notification of acceptance for filing, substantive review or awaiting the arrival of deficiency letters. Upon receipt of a marketing order, regulatory obligations continue for the entire life cycle of a product in the market. The Food and Drug Administration (FDA) extensively evaluates the data at intervals to make a re-assessment of risk-benefit and ascertain the product’s suitability to be keep the designation “appropriate for the protection of public health” (APPH).
Post Market Surveillance (PMS)
PMS responsibilities are complex. They encompass multidisciplinary functions within a business, and involve in-depth data gathering and analysis, submitted on a frequency agreed with the regulatory authority. This article delves into the requirements which can be put into three main categories:
- Changes to manufacturing processes and controls
- Changes to the health risks associated with the product
- Sales, distribution, and marketing information
- Compliance with all these aspects is necessary to ensure the product is maintained in market
You can read the full article here:
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