Consultation

Implement increased documentation and reporting processes for traditional herbal medicinal products. Ensure staff receive training on the complexities involved in signal management for these products.

Sponsors must implement early communication strategies with the CDE regarding RWE study plans as a prerequisite for pediatric indication extension submissions.

Suppliers must implement new protocols for safety reporting and record-keeping as per the proposed framework.

MAHs must align their workflows to accommodate the updated requirements for signal management and ICSR submissions as per the discussions in the ISG meeting.