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]

08

Mag

Farmaceutica, Gemmato: 'per Testo unico deadline entro dicembre'

"Il Testo unico sulla legislazione farmaceutica, che ha come obiettivo quello compendiare 800 fra...

08

Mag

Min. Salute Gemmato: “Testo unico farmaceutico entro dicembre 2026”

Il sottosegretario alla Salute indica la tabella di marcia della riforma. Al centro accesso ai farmaci...

08

Mag

Precursori droghe: controllo esteso a 9 nuove sostanze dal 18 settembre 2026

Regolamento delegato (UE) 2026/314 della Commissione del 9 febbraio 2026 recante modifica del regolamento...

08

Mag

US FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight

The U.S. Food and Drug Administration (FDA) on Wednesday unveiled a one-day inspectional assessment...