CTIS users are now required to actively monitor notifications daily to ensure timely awareness of safety-related tasks.
Pharmacovigilance teams must adopt a structured classification approach to risk analysis, impacting how cases are assessed and notified.
Stakeholders must integrate the new guidance into their signal management and literature surveillance processes to ensure compliance with updated PMDA expectations.
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.
Implement mandatory quality checks and oversight for all AI-generated inspection responses to meet MHRA expectations for accuracy.
MAHs and trial sponsors must align their safety monitoring and data collection workflows with the new GCP principles established in ICH E6(R3) Annex 2.
MAHs must update their application submission procedures to utilize the SUGAM portal for all relevant post-approval changes from June 24, 2026.
