News dal mondo
24
Feb
Industry clamors for clearer guidance on transition to ICH M4Q(R2)
The pharmaceutical industry has expressed a need for greater clarity regarding the timeline for converting quality information for new and existing drug and biologics dossiers to the common technical document (CTD) format described in the International Council for Harmonisation’s (ICH) M4Q(R2) guideline. These were among the many concerns raised by the EU pharmaceutical industry in their feedback submitted in response to the European Medicines Agency’s (EMA) request for comment on the M4Q(R2) guideline. The guideline was published by ICH in May 2025.. [EMA]
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US FDA Draft Guidance on Establishing Impurity Specifications for Antibiotics
FDA issued the draft guidance for industry, Establishing Impurity Specifications for Antibiotics.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
19 Mar
Nuove norme UE sui farmaci: più incentivi all’innovazione e controllo della disponibilità
As Iran war squeezes Middle East drug shipments, experts warn of longer-term effects on US manufacturing, generics
Farmalabor: investiti 8,5 milioni in un progetto per le malattie rare
17 Mar
EMA Management Board: highlights of March 2026 meeting
13 Mar
Dal China all’India-shoring, il rischio di una nuova dipendenza
11 Mar
EU Finalizes Pharma Reform Package, Clarifies New Rules On Modular Market Protection
PFAS restriction proposal: ECHA’s Socio-Economic Analysis Committee agrees its draft opinion
Farmaci - Gemmato: In cantiere anche un ritorno nazionale alla chimica farmaceutica di base
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