|
|
THE PULSE OF GLOBAL PHARMA REGULATION
|
| |
|
AMERICAS · FDA INTELLIGENCE
US edition · 2026-01
|
|
| |
|
NEWS
Increase in Drug Quality Inspections
The FDA conducted 972 drug quality inspections in 2024, marking a 27% increase from the previous year, with a significant focus on foreign manufacturing sites.
|
|
| |
|
|
NEWS
Warning Letters Highlight cGMP Violations
Approximately 35% of FY2025 warning letters cited cGMP violations, with a notable emphasis on contract manufacturers and CMOs, indicating a tightening of oversight.
|
|
| |
|
|
NEWS
Expansion of the 'Green List' Mechanism
The FDA's 'Green List' now targets GLP-1 products, with potential expansion to other high-risk classes, reflecting heightened scrutiny on foreign API sources.
|
|
| |
|
ARTICLE
FDA Enforcement Trends: January 2026 Overview
In January 2026, the FDA continued its rigorous enforcement of drug quality standards, with a focus on foreign manufacturing sites. The agency conducted inspections revealing significant compliance issues, particularly in contract manufacturing...
|
|
| |
|
REGULATORY · EMA
New EU Regulations on Drug Approval Processes
The European Medicines Agency has implemented new regulations aimed at streamlining drug approval processes, focusing on enhancing patient safety and expediting access to innovative therapies.
|
|
| |
|
|
REGULATORY · EMA
Strengthened Guidelines on Pharmacovigilance
Revised pharmacovigilance guidelines emphasize the importance of post-market surveillance and risk management plans, ensuring ongoing safety monitoring of medicinal products.
|
|
| |
|
|
REGULATORY · EMA
Increased Transparency in Clinical Trials
New transparency measures require detailed reporting of clinical trial results, aiming to improve public access to information and enhance trust in the pharmaceutical sector.
|
|
| |
|
Numbers of the month
|
Drug Quality Inspections Conducted
+27% YoY
|
New Import Alerts Issued
Sharp increase from previous years
|
cGMP Violations in Warning Letters
Notable focus on contract manufacturers
|
|
| |
|
Reports & resources
|
REPORT · Intuition Labs
An in-depth analysis of FDA enforcement actions and trends affecting the pharmaceutical industry in 2026.
|
|
GUIDANCE · DRK Research
Guidance on best practices for maintaining compliance with current Good Manufacturing Practices in the pharmaceutical sector.
|
|
REPORT · GMP Compliance
Insights into recent FDA warning letters and the common deficiencies cited in the pharmaceutical industry.
|
|
| |
|
Official sources
- https://www.fda.gov/media/191472/download?attachment
- https://www.fda.gov/media/191365/download
- https://www.federalregister.gov/documents/2026/02/20/2026-03326/agency-information-collection-activities-proposed-collection-comment-request-current-good
|
|
www.novapharmanews.com
For U.S. CDMO, biopharma, and supply-chain leaders.
US
· Edition 2026-01
· B2B pharma intelligence, generated and reviewed by editors.
© NovaPharmaNews. Trusted pharmaceutical intelligence covering FDA, EMA, NMPA, and PMDA regulatory developments across global markets.
|