Latest

Latest regulatory intelligence and pharmacovigilance briefings with verified source dates and role-specific action guidance.

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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publicMedicines and Healthcare products Regulatory Agency (MHRA) · United Kingdom · Updated Jun 4, 2026

Class 4 Medicines Defect Notification: Teva UK Ltd, Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe

Monitoring

Check stock for the affected batches of Ponlimsi (Denosumab) 60mg solution for injection and follow the instructions in the MHRA notice.

Signal ManagementLabelingRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Signal Management Lead

verifiedRegulatory action: Medicines recall/notification

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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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