Smart Packaging Streamlines Adverse Effect Reporting Process

At a Glance

• FDA’s new rule requires contact info for adverse-event reporting on primary and secondary packaging.
• The software provides a URL or QR code for packaging, tracks events, and formats them for FDA reporting.
• The developer, Registrar Corp., says it is developing versions for other industries.

 

Registrar Corp. has launched adverse event management (AEM) software in response to FDA’s Modernization of Cosmetics Regulation Act (MoCRA). The new regulation stipulates that contact information for reporting adverse events must be displayed on both primary and secondary packaging. The rule also calls for the collection of detailed personal and medical information from the consumer.

The AEM software solution provides cosmetic companies with an electronic contact in the form of a brand-specific URL or QR code that the consumer can use to report an adverse effect, according to Jaclyn Bellomo, Registrar’s senior director of cosmetic science and regulatory affairs.

“As a brand, you want to be the first one to know there is an issue with your product,” says Bellomo. “This contact communicates to the consumer where to report the adverse event so they avoid using other platforms, such as reporting an event to the FDA versus the brand.”

Consumers who visit the URL or scan the QR code on the package are directed to a landing page where they can enter all the necessary data required under MoCRA for reporting adverse events. The form, which consists of 40-plus fields, is designed to ensure that brands collect as much information as possible during this first point of contact with the consumer.

 

Beyond labeling, Solution Manages Compliance.

After collecting the data, the AEM platform 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.

Although Registrar launched the software to meet an immediate need in the cosmetic industry, Bellomo shares that the company is developing the software management solution for use in other industries in the future.

“Pharmaceuticals and nutraceuticals cannot have an electronic contact on the packaging for adverse event reporting, but the system can eventually be used to manage adverse events that come in via the mail or a phone call,” she says.

Once adverse events are entered into the system, the software would allow pharmaceutical and nutraceutical companies to manage communications between the consumer and th

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