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EUROPE · EMA INTELLIGENCE
EU edition · 2026-05
EU pharma briefing — 2026-05
 
Guidance on Remote and Hybrid GMP/GCP Inspections

REGULATORY · EMA

Guidance on Remote and Hybrid GMP/GCP Inspections

EMA has published new guidance indicating that remote and hybrid inspections will become routine. The focus is on ensuring data integrity and secure IT infrastructure for manufacturers and...

 
EMA Opens Consultation on Continuous Manufacturing

ARTICLE

EMA Opens Consultation on Continuous Manufacturing

The European Medicines Agency (EMA) has initiated a consultation on its draft reflection paper regarding continuous manufacturing for chemical medicinal products. This initiative aims to establish harmonised expectations for the development, validation...

 
Procedural Clarification on Variations

MANUFACTURING · EMA

Procedural Clarification on Variations

EMA has confirmed expectations for grouping and worksharing of Type IB/II variations when multiple EU facilities are affected, providing clarity for manufacturers navigating these changes.

 

Official sources

  1. https://www.ema.europa.eu/en/news-events/whats-new
  2. https://www.ema.europa.eu
  3. https://www.ema.europa.eu/en/human-regulatory/post-authorisation/variations
  4. https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice
  5. https://www.ema.europa.eu/en/human-regulatory/overview/clinical-guidelines/gmp-gcp-inspections
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