Earlier this month, SafetyCall attended The Personal Care Product Council’s (PCPC) Legal & Regulatory Conference in Quebec City, Canada. The conference was well attended by legal and regulatory leaders within the personal care space, and covered a variety of topics including clean beauty, updates on sunscreen regulations, pending and passed poly- and perfluoroakyl (PFAS) regulations, an address by Dr. Katz on the Modernization of Cosmetics Regulatory Act (MoCRA), and a session dedicated specifically to MoCRA.
Discussion regarding MoCRA was robust, and industry is anxious to receive formal guidance from FDA on matters covered in the legislation such as facility registration and mandatory product listing. Dr. Katz did provide an update during her address regarding the format for reporting adverse events. She clarified that FDA would accept reports on MedWatch 3500A’s, and is making adjustments to the Safety Reporting Portal (SRP) to allow for electronic submission of adverse events.
Except for new labeling requirements, these new requirements come into enforcement 1 year after enactment of the bill. That’s December 29th, 2023, just a few short months away! That means that manufacturers will be expected to comply with mandatory adverse event reporting, premarket safety substantiation, Good Manufacturing Practice, and mandatory facility registration and product listing by December 29th, 2023.
SafetyCall has assembled an internal working group which is hard at work preparing to support clients and potential clients subject to the new mandatory reporting requirements for cosmetics. Stay tuned for further updates on this new offering from Client Services. If you are not a SafetyCall client and interested in learning more about your adverse event obligations and how SafetyCall can help, please click here to fill out a contact form.
