Practical implication
Ensure all sites listed in marketing authorization applications are ready for inspection upon submission, and adhere to the new timelines for inspection requests and report submissions.
EMA has published a guideline for coordinating GMP inspections, effective from 10 September 2026, which impacts inspection processes for centrally authorised products.
What changed: New guidelines adopted in April 2026 set forth procedures for GMP inspections, with specific requirements including inspection requests by day 90 after marketing authorization application validation and the submission of inspection reports in English within specified timelines.
Why it matters: Compliance with these guidelines is crucial for the timely and effective inspection of manufacturing sites, affecting the approval and oversight of medicinal products in the EU.
Practical implication: Ensure all sites listed in marketing authorization applications are ready for inspection upon submission, and adhere to the new timelines for inspection requests and report submissions.
View original source
- Source: EMA - Regulatory and procedural guidelines RSS
- Published at source: 2026-09-07T00:00:00.000Z
- Discovered by monitor: 2026-09-07T21:35:42.364Z
Published from the regulator source ingestion pipeline after PV impact triage.
