News dal mondo

11

Mar

EMA outlines methods for evaluating supply chain vulnerabilities

The European Medicines Agency (EMA) has published a document detailing its methodology for monitoring potential vulnerabilities in the medicine supply chains. The agency said its new framework is intended to prevent potential shortages of drugs considered especially important on the Union List of Critical Medicines (ULCM).
 
On 10 March, EMA published the document that was originally adopted by its Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) on 17 November 2025. The agency said the methodology is intended to be practical and implementable, while avoiding duplication of existing processes and taking on unnecessary burdens...[EMA]

18

Giu

AIFA Sistema informatico Workflow Officine Materie Prime - Ulteriore Aggiornamento tecnico 18 maggio 2026

Formati files ammessi: PDF editabile o p7m. Scansioni a 200 dpi, anche in bianco e nero, per ottimizzare...

15

Mag

US FDA’s New AI-Informed Inspection Pilot and What It Means for Industry

We have written on this blog about FDA’s modernization agenda from several angles lately—from...

15

Mag

EU Regulators discuss new pharma legislation, AI, and more

A panel of European regulators answered questions during a town panel discussion at RAPS Euro Convergence...

15

Mag

US FDA official details top observations from QMSR inspections

The top observations identified in Form 483 reports from inspections conducted under the recently implemented...