guidance

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

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

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.

Healthcare professionals must report all serious incidents involving injectable devices to Swissmedic as outlined in the new guidance.

Sponsors must align their products with the updated safety and formulation requirements for permissible ingredients as per the new determination.

MAHs should prepare for enhanced regulatory collaboration, including potential joint oversight activities and reduced market friction between the UK and US due to closer alignment in regulatory decisions.

Review the consultation document and consider submitting feedback by 2026-07-31. Monitor for final regulatory changes affecting radiopharmaceutical safety monitoring and compliance.

Innovators must now utilize the Innovation Accelerator for access to regulatory expertise and guidance on pharmacovigilance and risk management strategies.

Stakeholders, including those involved in labeling and signal management, should consider the published comments to align future processes with the regulatory expectations detailed in the draft ICH E22 guideline.