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:

  • Facilitate exchange of information regarding medicinal products quality, safety and efficacy.
  • Increase alignment and coordination on topics related to medicinal products for human-use, in-line with the application legislation.
  • Mutual learning, capacity building and the sharing of best practices in regulatory science and public health.

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...