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]

17

Jul

Inside Pharma’s Push for More Resilient Supply Chains

Industry leaders from Samsung Biologics and Fujifilm Biotechnologies discuss how regional manufacturing,...

17

Jul

US FDA CDER plans new guidance on AI, electronic safety report submissions, and more

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has...

15

Jul

Riforma farmaceutica. Via libera della Commissione Sanità del Senato

 Le poche modifiche approvate non cambiano l'impianto della riforma. L’articolo 3 a...

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...