Regulator

EMA

Monitor European Medicines Agency pharmacovigilance and regulatory intelligence: PRAC signal assessments, EudraVigilance monitoring expectations under EU GVP, product information updates, and centrally authorised product safety actions. Each briefing maps EMA developments to workflows such as signal validation, label governance, and QPPV oversight.

2 updates · Sorted by impact priority

publicEMA · European Union · Updated Jun 5, 2026

Calcifediol PSUSA: Maintenance of Marketing Authorisation (PSUSA/00000491/202506)

Monitoring

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

Signal ManagementLabelingRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Signal Management Lead

verifiedRegulatory action: PSUSA

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publicEuropean Medicines Agency (EMA) · European Union · Updated May 29, 2026

EMA ETF recommends updating COVID-19 vaccines to target XFG variant for 2026/2027 campaign

Monitoring

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.

Signal ManagementLabelingRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Signal Management Lead

verifiedRegulatory action: Regulatory Recommendation / Public Health Communication

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