PV Bulletin

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Country Requirement

publicEuropean Medicines Agency · European Union · Updated Aug 26, 2026

Orphan Designation Granted for Daratumumab for AL Amyloidosis

Urgency: High

Regulatory requirements for daratumumab will need to be reviewed in light of the orphan designation status granted by the EMA.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
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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

Urgency: High

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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publicFDA · USA · Updated Aug 26, 2026

Exemptions Granted to Small Business Dispensers Under the Drug Supply Chain Security Act

Monitoring

Small business dispensers are encouraged to complete a mandatory assessment survey by September 22, 2026, and do not need to submit information to the FDA while utilizing these exemptions.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicCanada's Drug Agency (CDA-AMC) · Canada · Updated Jun 5, 2026

CDA-AMC Post-Market Drug Evaluation (PMDE) Program Procedural Update

Monitoring

Review updated PMDE Program procedures on CDA-AMC website and assess impact on current post-market surveillance activities in Canada.

Signal ManagementCountry ComplianceRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead, QPPV
verifiedRegulatory action: SOP
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