Registrar Corp has introduced its Adverse Event Management (AEM) software to aid the cosmetic industry in complying with the FDA’s Modernization of Cosmetics Regulation Act (MoCRA). MoCRA introduces stricter requirements for cosmetic product safety, including displaying contact information on packaging, collecting consumer medical data, and reporting serious adverse events to the FDA within 15 days. Previously, these measures were voluntary, but now they are mandatory, requiring coordination between various departments like marketing, legal, quality assurance, and R&D.
Jaclyn Bellomo, Senior Director of Cosmetic Science and Regulatory Affairs at Registrar Corp, emphasizes the complexity of MoCRA’s adverse event reporting requirements. Existing complaint systems are insufficient to meet these new demands, which involve real-time data collection and investigation to quickly assess adverse events. Registrar’s AEM software streamlines this process by offering a secure, brand-specific URL or QR code on product packaging that directs consumers to a form for reporting issues. The software then tracks these events globally, transmits the data to internal stakeholders, and formats serious cases for FDA MedWatch submission.
AEM is also designed with consumer-friendly intake, real-time monitoring, and ISO27001-certified storage security, ensuring the secure handling of sensitive medical information. It allows companies to monitor product issues early and manage communication between internal departments. The software has already helped over a thousand companies achieve MoCRA readiness, including product registration and label reviews. As the FDA ramps up enforcement, Registrar Corp’s AEM software aims to fill the urgent need for compliant adverse event reporting in the cosmetics industry, ultimately improving consumer safety and industry transparency.
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