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]
22
Mag
Min. Salute - Strategia nazionale sulla salute e sicurezza sul lavoro, approvata in Conferenza Stato-Regioni
La Conferenza Stato-Regioni ha approvato il 21 maggio 2026, tramite accordo formale, la Strategia nazionale...
22
Mag
Testo unico farmaceutica, i lavori entrano nel vivo: a breve l’esame dei 302 emendamenti
...L’iter del provvedimento è ormai prossimo a entrare finalmente nel vivo, con l’esame...
18
Mag
AIFA Sistema informatico Workflow Officine Materie Prime - Ulteriore Aggiornamento tecnico 18 maggio 2026
Formati files ammessi: PDF editabile o p7m. Scansioni a 200 dpi, anche in bianco e nero, per ottimizzare...
15
Mag
US FDA’s New AI-Informed Inspection Pilot and What It Means for Industry
We have written on this blog about FDA’s modernization agenda from several angles lately—from...