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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]

07

Mag

AIFA - Sistema informatico Workflow Officine Materie Prime - aggiornamento

Tutte le officine farmaceutiche di produzione e/o importazione materie prime sono tenute a trasmettere...

30

Apr

AIFA pubblica il Terzo Position Paper sui farmaci biosimilari

È online il terzo Position Paper AIFA sui farmaci biosimilari. L’aggiornamento del documento...

29

Apr

US GDUFA IV Talks Reach Tentative Agreement; America First Application Fee Waiver Added

US FDA GDUFA Reauthorization performance goals and program enhancements Riscal years 2023-2027 - Meeting...

28

Apr

Sun Pharma compra Organon

Sun Pharmaceutical Industries ha firmato un accordo definitivo per acquisire Organon &...

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