European Medicines Agency (EMA)

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

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

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, 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.