PV Bulletin

PSUSA/00000414/202601 - periodic safety update report single assessment

Periodic safety update report single assessments (PSUSAs) are single assessments of related periodic safety update reports (PSURs) for active substances contained in medicines authorised in the European Union (EU).

Primary source: Website data protection notice

Translated From French

PV Bulletin does not take any responsibility for translation errors or omissions, though it has used the best available translation engine.

PV Impact Brief

Urgency: HighConfidence: high

What changed

A new periodic safety update report single assessment for biotin has been published, impacting the reporting requirements for associated medicinal products.

Why it matters

This PSUSA may necessitate updates to pharmacovigilance practices and signal management processes to ensure compliance with the new reporting obligations.

Action needed

Regulatory intelligence should be updated to reflect the new PSUSA, and signal management processes may require reviews based on new safety information.

Relevant for
PV Quality Lead
Processes impacted
Signal Management
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Sep 3, 2026

Full briefing

Practical implication

Regulatory intelligence should be updated to reflect the new PSUSA, and signal management processes may require reviews based on new safety information.

The European Medicines Agency (EMA) has published a new periodic safety update report single assessment (PSUSA/00000414/202601) concerning the active substance biotin, outlining the implications for related medicinal products authorized in the EU.

What changed: A new periodic safety update report single assessment for biotin has been published, impacting the reporting requirements for associated medicinal products.

Why it matters: This PSUSA may necessitate updates to pharmacovigilance practices and signal management processes to ensure compliance with the new reporting obligations.

Practical implication: Regulatory intelligence should be updated to reflect the new PSUSA, and signal management processes may require reviews based on new safety information.

View original source

  • Source: EMA - What's new RSS
  • Published at source: 2026-09-03T00:00:00.000Z
  • Discovered by monitor: 2026-09-03T21:46:08.709Z

Published from the regulator source ingestion pipeline after PV impact triage.

#Safety Signals#Reporting Requirement#Source-ingestion#Regulator-monitor#European Union#Ema.europa.eu#Translated From French

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