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
07
Mag
AIFA - Sistema informatico Workflow Officine Materie Prime - aggiornamento
Tutte le officine farmaceutiche di produzione e/o importazione materie prime sono tenute a trasmettere...
30
Apr
AIFA pubblica il Terzo Position Paper sui farmaci biosimilari
È online il terzo Position Paper AIFA sui farmaci biosimilari. L’aggiornamento del documento...
29
US GDUFA IV Talks Reach Tentative Agreement; America First Application Fee Waiver Added
US FDA GDUFA Reauthorization performance goals and program enhancements Riscal years 2023-2027 - Meeting...
28
Sun Pharma compra Organon
Sun Pharmaceutical Industries ha firmato un accordo definitivo per acquisire Organon &...
le ultime news
20 Feb
US FDA: svolta storica: basterà un solo studio registrativo per approvare i nuovi farmaci
11 Feb
AIFA - Aggiornamento della Nota esplicativa relativa alla procedura del “silenzio/assenso” in accordo con la nuova EC Classification Guideline sulle variazioni
AIFA - Nuova modalità Multi-Beneficiario per i pagamenti online delle tariffe previste dal D.M. 6 dicembre 2016
09 Feb
Pharma expert discusses effort to standardize CMC quality information
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