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
USA . La Corte Suprema boccia i dazi globali di Trump: cosa cambia e perché il pharma resta nel mirino
l 20 febbraio 2026 la Supreme Court of the United States ha inferto un duro colpo alla strategia commerciale...
20
NerPharma acquistata da un colosso farmaceutico francese
N Nerpharma, l’azienda di produzione farmaceutica del gruppo...
Generic industry against giving fee breaks to firms setting up operations in the US
The generic drug industry told the US Food and Drug Administration (FDA) that it opposes waiving annual...
US FDA: svolta storica: basterà un solo studio registrativo per approvare i nuovi farmaci
La Food and Drug Administration cambia paradigma: per l’approvazione dei nuovi farmaci sarà...
le ultime news
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04 Feb
FDA, EMA officials encourage companies to pilot eCTD 4.0
03 Feb
China revises drug administration regulations to spur innovation, tighten oversight
02 Feb
USA - A Quality Tax for Foreign Drug Makers? The Links Between National Security, Trade Deals, and Drug Quality.
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
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