News from the world
16
Jul
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]
21
Aug
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...
14
Aug
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
Aug
UE approva acquisto di Recordati da parte di GBL e CVC
La Commissione europea ha approvato, ai sensi del Regolamento UE sulle concentrazioni,...
10
Aug
Wise Equity investe in E-Pharma Trento
Wise Equity, società di gestione del fondo Wisequity VI, e Unifarm, azionista unico...
latest news
09 Jun
Pharma, Italia leader, ma debole nei principi attivi, produzione da potenziare
04 Jun
AIFA - Indicazioni sulla modalità di comunicazione dei periodi di chiusura estiva dei siti di produzione di sostanze attive
27 May
Generics drugmaker Sandoz calls for EU to probe alleged China dumping
22 May
Min. Salute - Strategia nazionale sulla salute e sicurezza sul lavoro, approvata in Conferenza Stato-Regioni
22 May
Testo unico farmaceutica, i lavori entrano nel vivo: a breve l’esame dei 302 emendamenti