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. The new DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC The new REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006
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
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
Sun Pharma compra Organon
Sun Pharmaceutical Industries ha firmato un accordo definitivo per acquisire Organon &...
le ultime news
10 Apr
“Difenderemo il farmaco made in Italy” - Sottosegretario alla Salute Gemmato: Dal payback alla dipendenza da India e Cina
Contract manufacturing deals for drugs marketed in US shift to Europe
09 Apr
AIFA rafforza il dialogo con gli stakeholder: approvati due nuovi regolamenti
US-Iran ceasefire provides potential relief for pharma logistics, cost structures
07 Apr
Trump signs order imposing 100% tariff on patented pharmaceuticals, ingredients
Trump tariff order pushes onshore drug manufacturing longer term: analysts
02 Apr
AIFA - Aggiornamento Tariffe ISTAT dal 1 aprile 2026
AIFA - Per la prima volta i vertici in missione istituzionale in Giappone
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