News from the world
04
Nov
US FDA unannounced foreign inspections in China and India increased in FY 2026
A top US Food and Drug Administration (FDA) enforcement official announced that the agency conducted more unannounced drug inspections in India and China in FY 2026 compared to the previous year. The increase is attributed to an effort by the agency to increase unannounced foreign inspections to achieve inspection parity between domestic and international facilities. “For generic drugs and biosimilars, this is not an abstract policy issue. The manufacturing network serving US patients is global, and pharmaceuticals serving the same market should be held to the same expectations. That is why the FDA has substantially increased the use of unannounced inspections overseas,” Elizabeth Miller, associate commissioner for inspections and investigations at FDA’s Office of Inspections and Investigations, said during a presentation at the Association for Accessible Medicines (AAM) GRx+Biosims conference on Tuesday...[RAPS]
30
Oct
US FDA Releases Updated Concept of Operations for the Facility Evaluation and Inspection Program for Human Drugs
FDA has published the revised Integration of the FDA Facility Evaluation and Inspection Program for Human...
30
Oct
Importazione di sostanze attive - Elenco dei Paesi terzi riconosciute equivalenti EU
DECISIONE DI ESECUZIONE (UE) 2026/2347 DELLA COMMISSIONE del 23 ottobre 2026 che modifica la decisione...
30
Oct
Accesso ai Servizi Online AIFA: evoluzione digitale all’insegna della sicurezza e della semplificazione
L’Agenzia Italiana del Farmaco prosegue il percorso di efficientamento e digitalizzazione delle...
29
Oct
Riordino legislazione farmaceutica: voto alla Camera la prossima settimana
Scaduto il termine del 26 ottobre per la presentazione degli emendamenti in Commissione Affari...