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
28
Apr
Sun Pharma compra Organon
Sun Pharmaceutical Industries ha firmato un accordo definitivo per acquisire Organon &...
27
US QMM: Participants scored well on commitment to quality, lower on advanced manufacturing
Pharmaceutical companies participating in the US Food and Drug Administration (FDA) Quality Maturity...
23
Top Drugs at Risk of Supply Shortages
Nearly half of 100 vulnerable medicines have at least one key starting material sourced exclusively...
Regulatory considerations for pharmaceutical excipient selection
The article discusses the role and importance of excipients in medicines, focusing on regulatory aspects...
le ultime news
27 Feb
Quantum computing nelle life sciences: a Milano un convegno per l’industria farmaceutica
24 Feb
Industry clamors for clearer guidance on transition to ICH M4Q(R2)
23 Feb
USA . La Corte Suprema boccia i dazi globali di Trump: cosa cambia e perché il pharma resta nel mirino
20 Feb
NerPharma acquistata da un colosso farmaceutico francese
Generic industry against giving fee breaks to firms setting up operations in the US
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
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