ICSR reporting

Stakeholders, including manufacturers and clinicians, must review and potentially revise their post-market vigilance and safety monitoring protocols in response to the FDA's proposed regulatory approaches for generative AI devices.

Clinical safety and pharmacovigilance teams must ensure that their SUADR reporting processes are aligned with the new 7-day and 15-day notification timelines, and maintain robust systems for collecting safety data from international sites.

Manufacturers and stakeholders in South Korea must review and update their safety reporting systems and Standard Operating Procedures (SOPs) to comply with the revised regulations.

Clinical safety and pharmacovigilance teams must update their study protocols and adverse event reporting procedures to align with the revised guidance by October 2, 2026.

MAHs and sponsors must review and potentially update internal SOPs and reporting forms that currently reference 'gender' to ensure compliance with the updated terminology and definitions.

MAHs are required to ensure their safety database systems are configured to the updated E2B(R3) specifications and verify B2B gateway connections before the August 2026 deadline.

Update electronic safety reporting systems and pharmacovigilance databases to implement new rules to ensure all submissions use GENC 3-letter country codes and include the required fields as of July 20, 2026.

Holders of Certificates of Registration and Clinical Research Organisations must update their safety databases and reporting workflows to comply with the new electronic reporting requirements for AEs and SAEs.

Clinical trial sponsors must update their internal SOPs for safety reporting and ensure staff are trained on the new submission steps for ASRs through the CTIS platform.

MAHs are encouraged to transition to the new digital service for all pharmacovigilance reporting and utilize the feedback function during the beta phase to improve the service.

Healthcare providers must ensure patient registrations and comply with adverse event reporting as per the renewed compassionate use framework, which includes the collection and analysis of safety data.

Investigators need to modify trial protocols and safety reporting mechanisms in line with the latest ISO 14155 updates to ensure compliance for upcoming high-risk clinical trials.

Safety lead to: (1) perform a UK-clinical-trial safety reporting gap assessment against MHRA’s effective guidance sections (MedDRA coding; AE/SAE; RSI governance; SUSARs; annual safety reporting; USMs; serious breaches; temporary suspension), (2) update controlled SOPs/WIs and training records to reflect “effective” status as of 28 Apr 2026, and (3) document deviations/gaps and open CAPA where needed for ongoing UK trials and new submissions.

Manufacturers must implement processes for device registration in swissdamed before placing devices on the market, with immediate attention needed for vigilance-reportable incidents.

Ensure compliance with updated SUSAR reporting timelines (15 days), notify SFDA of Phase IV trials within 20 working days post-IRB approval, and prepare for the financial fee of 15,000 Saudi Riyals for clinical trial evaluations.

Review and update data submission practices to align with the new technical specifications; ensure compliance with FDA-supported data standards.

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.

1) Verify your internal signal assessment narrative for GLP-1 RAs reflects FDA’s statement that the preliminary evaluation does not suggest a causal link; 2) Check whether any company-facing statements, FAQs, or labeling change proposals referencing suicidality need to be updated for consistency with FDA’s current public position; 3) Log the FDA update in regulatory intelligence tracking and maintain monitoring for further FDA conclusions or requests (including the linked 13 Jan 2026 communication).

Fda update requires triage for Local Affiliate Compliance, ICSR Submission, Device Vigilance; confirm local obligations and document follow-up actions.

Mhra update requires triage for Signal Validation, Risk Management, Local Affiliate Compliance; confirm local obligations and document follow-up actions.

Customers are required to quarantine affected kits, complete response forms, and destroy the kits. Notification must also be sent to distributors who should inform their customers of these updated actions.

Implement enhanced surveillance and tracking of Salmonella cases linked to imported eggs, potentially increasing ICSR submissions related to these infections.

Cattle producers must administer Bimectin injection within specified timelines (24 hours post-birth, at castration, or on wound appearance) and observe a 35-day withdrawal period before slaughter to prevent drug residues in food.

Healthcare professionals must include daraxonrasib in adverse event reporting as the new treatment option is now available for eligible patients.

Consumers should consult healthcare professionals if using this product and report any adverse effects to FDA’s MedWatch Safety Information.

Healthcare providers and manufacturers must now comply with new reporting obligations for adverse reactions associated with the use of Imaavy and ensure adherence to increased compliance requirements for its administration.

Organizations must increase scrutiny and evaluation of vaccine safety profiles for lots identified in the notification of non-compliance.

Review and update product monitoring and risk management plans to align with the new safety assessment standards and AMR surveillance requirements as specified in the updated guidance.

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.

Organizations must update their adverse event reporting processes to align with the clarified classification of borderline products effective immediately.

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