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US FDA Draft Guidance on Establishing Impurity Specifications for Antibiotics
FDA issued the draft guidance for industry, Establishing Impurity Specifications for Antibiotics.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...
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29 Gen
US FDA Announces PreCheck Implementation Roadmap
28 Gen
Industry wants more streamlining following recent EU reforms
FDA official offers tips on leveraging AI in drug manufacturing
Testo unico legislazione farmaceutica. La delega torna a Palazzo Chigi
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