News from the world
13
Jul
US FDA Proposes Rule to Modernize Drug Manufacturing Registration
Proposed rule would streamline registration for advanced distributed manufacturers and increase visibility into foreign drug supply sources..[US FDA]
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...
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17 Jul
Inside Pharma’s Push for More Resilient Supply Chains
17 Jul
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16 Jul
EU DG SANTE and EMA sign Working Arrangement with New Zealand Ministry of Health
15 Jul
Riforma farmaceutica. Via libera della Commissione Sanità del Senato
14 Jul
China NMPA conducts management review of QMS for regulation of vaccine and drug GMP compliance
14 Jul
AIFA: “Cerca un farmaco”: disponibili nuove informazioni sullo stato di commercializzazione dei medicinali
13 Jul
ECHA: riforma dell’Agenzia europea delle sostanze chimiche
13 Jul
US FDA Proposes Rule to Modernize Drug Manufacturing Registration