PV Bulletin

Monthly Reporting of Medicines Under Evaluation by EMA

As of March 2025, the EMA will publish an Excel listing of medicines under evaluation, including details on extension applications and type II variations.

Primary source: View

PV Impact Brief

MonitoringConfidence: high

What changed

The EMA will publish detailed reporting in Excel format starting March 2025, covering extension applications and type II variations to authorized indications.

Why it matters

This change enhances the transparency and accessibility of information regarding new human medicines under evaluation, facilitating better regulatory planning and compliance monitoring.

Action needed

Update internal systems and workflows to integrate monthly Excel reports from EMA starting March 2025, ensuring timely capture of information on medicines under evaluation and any extension applications.

Relevant for
Regulatory Intelligence Lead
Processes impacted
Signal Management
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Aug 26, 2026

Full briefing

Practical implication

Update internal systems and workflows to integrate monthly Excel reports from EMA starting March 2025, ensuring timely capture of information on medicines under evaluation and any extension applications.

Beginning March 2025, the European Medicines Agency (EMA) will provide monthly updates in Excel format regarding medicines under evaluation by the Committee for Medicinal Products for Human Use (CHMP). This will include information on the start of procedures for extension applications and type II variations proposing extensions of authorized indications, aiding in data analysis and regulatory transparency.

What changed: The EMA will publish detailed reporting in Excel format starting March 2025, covering extension applications and type II variations to authorized indications.

Why it matters: This change enhances the transparency and accessibility of information regarding new human medicines under evaluation, facilitating better regulatory planning and compliance monitoring.

Practical implication: Update internal systems and workflows to integrate monthly Excel reports from EMA starting March 2025, ensuring timely capture of information on medicines under evaluation and any extension applications.

View original source

  • Source: EMA - Good pharmacovigilance practices
  • Published at source: 2026-08-26T11:55:00.000Z
  • Discovered by monitor: 2026-08-27T21:49:15.260Z

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

#Safety Signals#Guidance#Source-ingestion#Regulator-monitor#European Union#Ema.europa.eu

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