revised

MAHs and sponsors must register for an EMA account and appropriate role to submit via the IRIS platform, as this is a new requirement for all IRIS submissions.

Organizations must establish an active EMA user account, ensure they have a valid EMA customer account number, and complete the SPOR/OMS registration process within five to ten working days if not previously registered.

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

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

Update internal labeling workflows to align with the revised checklist; ensure submission documents meet updated formatting requirements for linguistic review.

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

Review updated PMDE Program procedures on CDA-AMC website and assess impact on current post-market surveillance activities in Canada.