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

Review the PSUSA documents for calcifediol and ensure alignment with any PRAC recommendations if applicable.

Marketing authorisation holders should prepare to update their COVID-19 vaccines to target the XFG variant for the upcoming campaign; monitor for further regulatory guidance and prepare for potential strain change submissions.

Stakeholders should prepare for discussions regarding veterinary medicinal product reviews, specifically focusing on maximum residue limits and ensure all interests are declared by participants.

Stakeholders can submit NAMs data by completing the prescribed application form, available until Q3 2027.

Update internal systems and workflows to integrate monthly Excel reports from EMA starting March 2025, ensuring timely capture of information on medicines under evaluation and any extension applications.

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.

Update workflows and SOPs to incorporate the new biowaiver criteria, particularly in regulatory filing processes for applications involving additional strengths of solid oral dosage forms.