Registrar Corp. has announced the launch of Adverse Event Management (AEM) software to enable cosmetics companies to comply with the U.S. Food and Drug Administration’s (FDA's) stringent mandates for adverse event reporting under the new Modernization of Cosmetics Regulation Act (MoCRA).
See related: How Cosmetics Companies Can Avoid MoCRA Compliance Pitfalls and Litigation
5 MoCRA Mandates for Adverse Event Reporting
Per Registrar Corp., MoCRA mandates reporting based on the FDA’s medical device and drugs reporting process, including:
- Display contact information on both the primary and secondary packaging;
- Collect detailed personal and medical information from the consumer;
- Investigate to determine if the adverse event is a “serious” event;
- Report “serious” adverse event to the FDA within 15 business days; and
- Record all health-related adverse events and maintain for up to six years.
Coordinating Departments for Adverse Event Reporting
Registrar Corp. highlights that the described adverse event reporting will not only impact compliance and regulatory departments, but also require tight coordination with marketing (product labeling), quality and manufacturing (investigation), legal (consumer liability) and R&D (formulation safety).
“MoCRA’s Adverse Reporting requirements are incredibly complex and the existing consumer complaints process simply will not work,” said Jaclyn Bellomo, Registrar’s senior director of cosmetic science and regulatory affairs. “The consumer’s medical data needs to be securely collected, processed in real-time and investigated quickly to meet the 15-day serious adverse reporting requirement.”
See also: [poll results] How prepared are you for MOCRA requirements?
AEM Software to Track and Translate Events
Registrar’s Adverse Event Management (AEM) software has been purpose-built for cosmetics companies. Per the company, the AEM platform securely intakes sensitive consumer medical data, tracks all adverse events for all products globally, transmits information to internal stakeholders and formats serious adverse events to the FDA MedWatch format for submission to the FDA.
Key AEM Software Benefits
Per Registrar Corp., the platform offers the following.
- Consumer-friendly intake: Consumers can quickly scan a QR code on the product label and enter the required data, photos and documents needed for prompt investigation.
- Real-time tracking and monitoring: The system monitors adverse events globally for every SKU in real time and for the earliest indication of potential safety or quality issues;
- Protection of medical/personal data: The system offers ISO27001-certified security for storage and transmission of medical and personal identifiable information (PII).
- FDA MedWatch compatibility: Serious adverse event reports are pre-formatted to the FDA requirements for quick upload and submission.
"In the past six months, we have helped [more than] a thousand cosmetics companies get MoCRA-ready with product listings, registrations and label reviews,” said Raj Shah, CEO of Registrar Corp. “As FDA enforcement now ramps up and retailers [pressure] brands to get fully MoCRA compliant, we recognized the urgent need to solve their Adverse Events need with our AEM software.”
