EMA

MAHs and technical teams must review the revised API registration requirements and implement necessary system updates to comply by the established timelines.

Manufacturers must verify that their products meet the newly established acceptable intake levels for nitrosamines and implement necessary quality control measures to keep impurities within limits.

Update product information and guidance for use in elderly populations for Ixchiq; ensure compliance with PRAC recommendations.

Ema update requires triage for Local Affiliate Compliance, Vendor Oversight, Inspection Readiness; confirm local obligations and document follow-up actions.

Ema update requires triage for Label Governance, Risk Management, AI / GxP Governance; confirm local obligations and document follow-up actions.

Review updated EMA guidance on mechanistic model reporting and qualification when published; align sponsor submissions with new qualification pathways and reporting requirements for MIDD and safety-related models.

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.