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Notified Bodies and medical device manufacturers should adhere to the updated requirement of using the IRIS platform for notification and submission processes concerning companion diagnostics, ensuring compliance with the new timelines and submission methods.

MAHs and sponsors of priority medicines must review the updated PRIME guidance to ensure compliance with new interaction expectations, particularly regarding risk management planning and post-authorisation safety monitoring.

MAHs and SMEs must review the updated fee structures and assess the potential for fee reductions on safety-related submissions to align with the new regulatory framework.

Marketing authorisation holders must update Product Information (SPC and PL) in accordance with CVMP monthly recommendations, and ensure local affiliates are informed of new safety instructions.

Sponsors and MAHs must review and align safety data collection and reporting protocols with the newly adopted guidelines while preparing for implementation of PRAC recommendations stemming from this meeting.

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.

MAHs must ensure draft protocols are placed correctly in the CTD and that submission planning considers the clarified assessment timelines, with RMP updates contingent upon PRAC endorsement.

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

MAHs are advised to incorporate the updated FAQs into their compliance workflows and ensure that their submissions adhere to the updated guidance.

CTIS users are now required to actively monitor notifications daily to ensure timely awareness of safety-related tasks.

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

Regulatory Intelligence Leads must incorporate the new reporting requirements and deadlines into their monitoring activities for affected products.

PV teams should update their workflows regarding inspection readiness, review standard operating procedures (SOPs) to align with the new GCP inspection coordination processes, and ensure that all relevant personnel are trained on the updated guidance.

PV teams should review and update their Standard Operating Procedures (SOPs) related to real-world data collection methodologies and ensure alignment with the new guidance emerging from the workshop. Training may also be required to enhance understanding of RWD's impact on regulatory submissions.

PV teams should update their regulatory intelligence monitoring workflows to include the timelines and requirements established by the EMA for thalassaemia treatments. It's essential to ensure adherence to the new guidelines in clinical trial designs.

Update workflows related to regulatory intelligence monitoring and ensure that all relevant SOPs reflect the new guidelines on clinical requirements for sickle cell disease treatments.

PV teams should update workflows and standard operating procedures (SOPs) to incorporate these clarified dossier requirements. Ensure that all biological product dossiers include necessary details as outlined by the new guidance and provide training to relevant staff on these changes.

PV teams should review and update Standard Operating Procedures (SOPs) to align with new EMA guidelines on data management, accessibility, and sharing. Ensure compliance with the security standards outlined by the EMA to protect sensitive data and maintain data integrity.

PV teams should update SOPs related to inspection readiness and regulatory intelligence monitoring to align with the new coordination steps and deadlines mandated in the INS-GCP-1 procedure.