Regulator

MHRA

Follow Medicines and Healthcare products Regulatory Agency drug safety and pharmacovigilance developments for Great Britain and Northern Ireland markets. PV Bulletin covers MHRA safety alerts, guidance changes, and inspection-relevant updates aligned with UK good pharmacovigilance practice and global regulatory intelligence workflows.

3 updates · Sorted by impact priority

publicMedicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) · United Kingdom · Updated Jun 15, 2026

Unique Liaison Programme between MHRA and FDA

Monitoring

MAHs should prepare for enhanced regulatory collaboration, including potential joint oversight activities and reduced market friction between the UK and US due to closer alignment in regulatory decisions.

Signal ManagementCountry ComplianceRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Signal Management Lead, QPPV

verifiedRegulatory action: Notice

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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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publicMHRA · United Kingdom · Updated Jun 29, 2026

MHRA: Updated information on the MHRA's service providing scientific and regulatory guidance to developers of innovative medical products

Monitoring

Innovators must now utilize the Innovation Accelerator for access to regulatory expertise and guidance on pharmacovigilance and risk management strategies.

Country ComplianceRegulatory Intelligence Lead

SOP Impact1 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, QPPV

verifiedRegulatory action: Guidance

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