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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]

10

Apr

“Difenderemo il farmaco made in Italy” - Sottosegretario alla Salute Gemmato: Dal payback alla dipendenza da India e Cina

“Mitigare il payback” che pagano le aziende farmaceutiche per rendere più attrattivo...

10

Apr

Contract manufacturing deals for drugs marketed in US shift to Europe

Biopharma companies are increasingly choosing to outsource manufacturing for the U.S. market to European...

09

Apr

AIFA rafforza il dialogo con gli stakeholder: approvati due nuovi regolamenti

I Regolamenti di AIFA Ascolta e AIFA Incontra sono stati approvati in via definitiva e pubblicati sulla...

09

Apr

US-Iran ceasefire provides potential relief for pharma logistics, cost structures

Rising oil prices and disrupted shipping routes drove up costs, delaying sensitive shipments, and forcing...

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