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publicFrench National Agency for the Safety of Medicines and Health Products (ANSM) · France · Updated Jun 29, 2026

ANSM Training on Pharmacovigilance Signal Detection Methodologies

Pharmacovigilance teams must adopt a structured classification approach to risk analysis, impacting how cases are assessed and notified.

Signal ManagementRegulatory Intelligence Lead

SOP Impact1 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Signal Management Lead

verifiedRegulatory action: Notice / Meeting

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publicPMDA · Japan · Updated Jun 29, 2026

Information Regarding Explanations to Driver Mutations in the Development of Anti-cancer Drugs

Urgency: High

Stakeholders must integrate the new guidance into their signal management and literature surveillance processes to ensure compliance with updated PMDA expectations.

Signal ManagementLiterature SurveillanceRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Signal Management Lead

verifiedRegulatory action: Guidance

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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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