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
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Dal China all’India-shoring, il rischio di una nuova dipendenza
Una ricerca universitaria, promossa da CPA Italy, sulla supply chain di principi attivi e intermedi mostra...
PFAS restriction proposal: ECHA’s Socio-Economic Analysis Committee agrees its draft opinion
The European Chemicals Agency’s Committee for Socio-Economic Analysis (SEAC) has agreed its draft opinion...
Farmaci - Gemmato: In cantiere anche un ritorno nazionale alla chimica farmaceutica di base
Il sottosegretario alla Salute Marcello Gemmato è intervenuto durante la presentazione del Rapporto...
EMA outlines methods for evaluating supply chain vulnerabilities
The European Medicines Agency (EMA) has published a document detailing its methodology for monitoring...
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