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
23
Apr
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...
21
TGA clarifies therapeutic goods are unaffected by chemical production and import ban
TGA has clarified the impact of Australia’s industrial chemicals standards on medicines, medical...
20
US FDA Draft Guidance on Establishing Impurity Specifications for Antibiotics
FDA issued the draft guidance for industry, Establishing Impurity Specifications for Antibiotics. This...
le ultime news
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“Difenderemo il farmaco made in Italy” - Sottosegretario alla Salute Gemmato: Dal payback alla dipendenza da India e Cina
Contract manufacturing deals for drugs marketed in US shift to Europe
09 Apr
AIFA rafforza il dialogo con gli stakeholder: approvati due nuovi regolamenti
US-Iran ceasefire provides potential relief for pharma logistics, cost structures
07 Apr
Trump signs order imposing 100% tariff on patented pharmaceuticals, ingredients
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