News from the world
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
15
Apr
Difendere il valore della chimica-farmaceutica nazionale significa difendere il diritto alla salute del cittadino italiano
Nella seconda uscita della rubrica Ipse dixit, Marcello Gemmato (Ministero Salute) affronta i nodi della...
14
Farmaceutica, surplus Ue a 221 mld nel 2025: Italia prima per import
Nel 2025 l'Unione europea ha esportato prodotti medicinali e farmaceutici per un valore di 366,2...
10
“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...
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19 Mar
As Iran war squeezes Middle East drug shipments, experts warn of longer-term effects on US manufacturing, generics
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EMA Management Board: highlights of March 2026 meeting
13 Mar
Dal China all’India-shoring, il rischio di una nuova dipendenza
11 Mar
PFAS restriction proposal: ECHA’s Socio-Economic Analysis Committee agrees its draft opinion
Farmaci - Gemmato: In cantiere anche un ritorno nazionale alla chimica farmaceutica di base
EMA outlines methods for evaluating supply chain vulnerabilities
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