Registrar Corp. has introduced an Adverse Event Management (AEM) software in response to the FDA’s Modernization of Cosmetics Regulation Act (MoCRA). This new regulation mandates that cosmetic brands include contact information on both primary and secondary packaging for reporting adverse events. The software provides companies with a brand-specific URL or QR code, enabling consumers to report issues directly to the brand instead of going to the FDA.
Jaclyn Bellomo, Senior Director of Cosmetic Science and Regulatory Affairs at Registrar Corp., explains that this direct communication allows brands to quickly identify potential product issues. Consumers who use the URL or QR code are directed to a detailed online form, consisting of over 40 fields, designed to capture all necessary data for MoCRA compliance.
The AEM software also offers comprehensive event management. It tracks all adverse events globally, transmits data to internal stakeholders, and formats serious events into the FDA’s MedWatch format for submission. While the software was initially developed for the cosmetics industry, Bellomo notes plans to expand its use to other sectors, including pharmaceuticals and nutraceuticals. For these industries, the system will manage adverse event reports that come via mail or phone, streamlining communication between consumers, brands, and internal departments.
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