Tag archive

Regulatory Update

publicEuropean Medicines Agency (EMA) · European Union · Updated Jun 5, 2026

EMA Updates Acceptable Intake Levels for Nitrosamine Impurities in Human Medicines

Manufacturers must verify that their products meet the newly established acceptable intake levels for nitrosamines and implement necessary quality control measures to keep impurities within limits.

Signal ManagementLabelingRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Signal Management Lead

verifiedRegulatory action: Regulatory Update

Read impact briefarrow_forward

publicDanish Medicines Agency · Denmark · Updated Jun 29, 2026

Clinical Trials E-mail Notifications Activation in CTIS

Urgency: High

CTIS users are now required to actively monitor notifications daily to ensure timely awareness of safety-related tasks.

Country ComplianceRegulatory Intelligence Lead

SOP Impact1 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, QPPV

verifiedRegulatory action: Regulatory Update

Read impact briefarrow_forward

Get updates for your PV role

Subscribe to impact-first pharmacovigilance updates. Select every role you want in your digest.

Digest roles: QPPV. Work email only