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Trade Publications

9月 26, 2024

会議5 有害事象報告に関するMoCRAの義務

Meeting 5 MoCRA Mandates for Adverse Event Reporting: Registrar Corp. Launches New Tool. Article image.

Registrar Corp has launched its Adverse Event Management (AEM) software to assist cosmetics companies in meeting the FDA’s new requirements MoCRA mandates. These mandates include displaying contact information on packaging, collecting detailed consumer medical data, investigating adverse events, reporting serious cases to the FDA within 15 days, and maintaining records for up to six years.

The AEM software is designed to streamline this process, requiring coordination across compliance, marketing, quality, legal, and R&D departments. Jaclyn Bellomo, Senior Director of Cosmetic Science and Regulatory Affairs at Registrar Corp, emphasizes that MoCRA’s adverse event reporting requirements are complex, making traditional complaint systems inadequate. To comply, brands need a secure, real-time method for data collection and reporting.

Registrar’s AEM software offers several features to address these needs. It enables consumer-friendly data intake by allowing consumers to scan a QR code on product labels, where they can provide necessary information, images, and documents for prompt investigation. The software tracks all adverse events globally, providing real-time monitoring for every SKU to identify potential safety or quality issues early. Additionally, AEM includes ISO27001-certified security for the storage and transmission of personal and medical data, ensuring compliance with data protection standards.

One of its most valuable features is FDA MedWatch compatibility, pre-formatting serious adverse event reports for quick upload and submission to the FDA. Raj Shah, CEO of Registrar Corp, notes that the company has already helped over a thousand cosmetics companies become MoCRA-compliant through product listings, registrations, and label reviews. With AEM, companies can now manage adverse events efficiently, aligning with FDA regulations and meeting industry demands for greater consumer safety.

Read the full article on Cosmetics & Toiletries.

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