News dal mondo
15
Mag
European Commission outlines plans to mobilize EMA to diversify supply chains
he European Commission has adopted a Global Health Resilience Initiative that gives EMA a role in diversifying global supply chains. Supply chain diversification is one of nine flagship initiatives proposed in the document. Believing that diversified and well-integrated global supply chains help build resilience, the Commission plans to work with global partners to address concentrations of production capabilities responsible for systemic risks. As part of the efforts, the Commission will mobilize EMA and the network of EU national regulatory authorities to support collaborative regulatory pathways. The goal is to support the development and manufacturing of key health products based on mutual interest. The Commission also plans to work with partner countries on regulatory aspects of health science, genome, and biodata repositories. [European Commission]
15
Mag
US FDA’s New AI-Informed Inspection Pilot and What It Means for Industry
We have written on this blog about FDA’s modernization agenda from several angles lately—from...
15
Mag
EU Regulators discuss new pharma legislation, AI, and more
A panel of European regulators answered questions during a town panel discussion at RAPS Euro Convergence...
15
Mag
US FDA official details top observations from QMSR inspections
The top observations identified in Form 483 reports from inspections conducted under the recently implemented...
13
Mag
Deal on tackling EU shortages of essential medicines
Prioritise investment in EU manufacturing capacity to increase autonomy “Buy European”...
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