Primary source: EMA - Regulatory and procedural guidelines RSS
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.
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.
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.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
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.
Published from the regulator source ingestion pipeline after PV impact triage.
Regulatory Intelligence teams must initiate checks to monitor compliance and management of this recall, ensuring affected lots are removed from distribution.
Monitor the supply chain developments and prepare to adjust inventory management practices as the end of the shortage approaches.
Monitor for changes in labeling requirements and risk management strategies as a result of the ongoing review by PRAC.
Signal management teams need to prepare for potential updates in labeling, usage guidelines, and monitoring requirements for injectable iron-containing medicines.
