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
10
Apr
“Difenderemo il farmaco made in Italy” - Sottosegretario alla Salute Gemmato: Dal payback alla dipendenza da India e Cina
“Mitigare il payback” che pagano le aziende farmaceutiche per rendere più attrattivo...
Contract manufacturing deals for drugs marketed in US shift to Europe
Biopharma companies are increasingly choosing to outsource manufacturing for the U.S. market to European...
09
AIFA rafforza il dialogo con gli stakeholder: approvati due nuovi regolamenti
I Regolamenti di AIFA Ascolta e AIFA Incontra sono stati approvati in via definitiva e pubblicati sulla...
US-Iran ceasefire provides potential relief for pharma logistics, cost structures
Rising oil prices and disrupted shipping routes drove up costs, delaying sensitive shipments, and forcing...
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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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