European Medicines Agency (EMA)

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.

Clinical trial sponsors must update internal standard operating procedures (SOPs), conduct staff training on the functionality of the new ASR module, and utilize the CTIS training environment to ensure readiness for compliance with the new workflow.

MAHs and technical teams must review the revised API registration requirements and implement necessary system updates to comply by the established timelines.

Manufacturers must verify that their products meet the newly established acceptable intake levels for nitrosamines and implement necessary quality control measures to keep impurities within limits.

Update product information and guidance for use in elderly populations for Ixchiq; ensure compliance with PRAC recommendations.

All electronic PV submissions must undergo new validation checks in accordance with the updated criteria to ensure compliance and accuracy.

MAHs must execute safety communication plans, update Risk Management Plans (RMPs), and revise product information including the Summary of Product Characteristics (SmPC) and Package Leaflet.

Incorporate enhanced requirements for monitoring pregnancy-specific safety signals into existing pharmacovigilance practices.

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