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
20
Apr
US FDA Draft Guidance on Establishing Impurity Specifications for Antibiotics
FDA issued the draft guidance for industry, Establishing Impurity Specifications for Antibiotics. This...
Alfasigma cede a Fine Foods il 100% di Sofar
Alfasigma S.p.A. comunica di aver sottoscritto un accordo per la cessione del 100% del capitale...
17
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...
le ultime news
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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
09 Mar
US FDA drafts guidance on best practices for responding to inspection observations
Intelligenza Artificiale e salute: le agenzie regolatorie al centro della rivoluzione farmaceutica
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