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
17
Apr
Sostanze stupefacenti, il Ministero aggiorna le tabelle: inclusa la classe dei Nitazeni tra le sostanze vietate
È stato pubblicato nella Gazzetta Ufficiale il Decreto ministeriale 2 aprile 2026, con il...
Gemmato: 'Iran. Rschio carenze farmaci, legge delega per rafforzare produzione nazionale. Convocherò tavolo'
"Un tema molto attuale riguarda il rischio di carenza di farmaci e principi attivi, anche alla luce...
16
Farmaci salvavita, l’Italia dipende all’80% da Cina e India. Gemmato: «Poche settimane di autonomia in caso di crisi»
L’Italia è seconda in Europa per produzione farmaceutica, con 56 miliardi di valore della...
Guerre e filiera vulnerabile: l’industria farmaceutica italiana cerca le contromisure
Non sono rose e fiori ma nemmeno, per ora, lacrime e sangue. L’industria farmaceutica italiana,...
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03 Feb
China revises drug administration regulations to spur innovation, tighten oversight
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USA - A Quality Tax for Foreign Drug Makers? The Links Between National Security, Trade Deals, and Drug Quality.
29 Gen
US FDA Announces PreCheck Implementation Roadmap
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