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EU DG SANTE and EMA sign Working Arrangement with New Zealand Ministry of Health
DG SANTE and the European Medicines Agency (EMA) have signed a Working Arrangement with New Zealand Ministry of Health (incorporating the New Zealand Medicines and Medical Devices Safety Authority - Medsafe) this week, to strengthen collaboration and exchange of information on medicinal products. The agreement was signed by DG SANTE Director-General Sandra Gallina and EMA Executive Director Emer Cooke. Director-General Audrey Sonerson signed for the New Zealand Ministry of Health. The purpose of this Working Arrangement is to strengthen cooperation between signatories across a range of areas in public health, while promoting the timely, secure exchange of information. Deliverables from the Arrangement will include: The Arrangement will run from 6 July 2026 [European Commission]
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AIFA - Consultazione pubblica per definire i criteri per l’inserimento delle confezioni dei farmaci nell’elenco delle carenze “critiche”
a Legge n. 182/2025 (“Legge Semplificazioni 2025”) ha riformato il sistema sanzionatorio...
21
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EDQM - Update to the guidance for electronic submissions of CEP applications
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has updated the guidance PA/PH/CEP...
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FDA’s GDUFA IV commitment letter supports onshoring of generic drug manufacturing
The agency wants to increase the fee starting in fiscal 2028 for all foreign API, finished dosage form,...
11
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UE approva acquisto di Recordati da parte di GBL e CVC
La Commissione europea ha approvato, ai sensi del Regolamento UE sulle concentrazioni,...
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