News dal mondo

11

Mar

EU Finalizes Pharma Reform Package, Clarifies New Rules On Modular Market Protection

  • A final version of the draft pharma reform package has been published, clarifying changes that the pharma industry can expect once the legal package enters into force.
  • The legislation, which comprises a new regulation and directive, will replace the existing framework that has been in place for more than two decades.
  • The pharma reform package introduces, among many other things, changes to market protection for new drugs in the EU.

     

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...