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EUROPE · EMA INTELLIGENCE
EU edition · 2025-12
EU pharma briefing — 2025-12
 
FDA CGMP Inspection Findings

REGULATORY · FDA

FDA CGMP Inspection Findings

Recent inspections by the FDA have highlighted ongoing compliance issues within several pharmaceutical manufacturing facilities. Key areas of concern include inadequate documentation practices and failure to adhere to...

 
FO

REGULATORY · FDA

Focus on Data Integrity in Inspections

The FDA has increased its scrutiny on data integrity during CGMP inspections, emphasizing the need for robust systems that ensure the accuracy and reliability of manufacturing data.

 
Key Regulatory Changes in the EU for 2025

ARTICLE

Key Regulatory Changes in the EU for 2025

The European Medicines Agency (EMA) has implemented significant regulatory changes in 2025 aimed at enhancing drug supply chain resilience. The Medicinal Shortages Steering Group (MSSG) has focused on vulnerable products, issuing recommendations...

 

Official sources

  1. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers
  2. https://www.gov.uk/government/publications/wholesalers-manufacturers-guidance-following-agreement-of-the-windsor-framework/wholesalers-manufacturers-guidance-following-agreement-of-the-windsor-framework
  3. https://www.ema.europa.eu/en/documents/other/qa-system-demo-q3-2025_en.pdf
  4. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers[3
  5. https://www.gov.uk/government/publications/wholesalers-manufacturers-guidance-following-agreement-of-the-windsor-framework/wholesalers-manufacturers-guidance-following-agreement-of-the-windsor-framework[5
  6. https://www.ema.europa.eu/en/documents/other/qa-system-demo-q3-2025_en.pdf[6
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