News from the world

14

Jul

China NMPA conducts management review of QMS for regulation of vaccine and drug GMP compliance

The National Medical Products Administration (NMPA) conducted its 2025 annual management review of the Quality Management System (QMS) for regulation of vaccine and drug Good Manufacturing Practice (GMP) compliance on June 30. NMPA Commissioner Huang Guo presided over the meeting and fully affirmed the suitability, adequacy and effectiveness of the NMPA's QMS in both areas...[NMPA]

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...