Regulatory intelligence & pharmacovigilance updates, mapped to your role.

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.

Utilize the IB template provided for cell therapy products in clinical trial applications, available under the 'Special Product Areas' section of the Danish Medicines Agency's website.

MAHs must implement safety monitoring protocols and ensure compliance with reporting obligations associated with the newly classified prescription drugs.

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