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”...
le ultime news
09 Mar
US FDA drafts guidance on best practices for responding to inspection observations
09 Mar
Intelligenza Artificiale e salute: le agenzie regolatorie al centro della rivoluzione farmaceutica
06 Mar
Testo unico Legislazione Farmaceutica,: assegnato alla X Commissione Senato
04 Mar
ECHA’s Risk Assessment Committee adopts its opinion on PFAS restriction proposal
27 Feb
US FDA Announces the 2026 QMM Prototype Assessment Protocol Evaluation Program
27 Feb
Quantum computing nelle life sciences: a Milano un convegno per l’industria farmaceutica
24 Feb
Industry clamors for clearer guidance on transition to ICH M4Q(R2)
23 Feb
USA . La Corte Suprema boccia i dazi globali di Trump: cosa cambia e perché il pharma resta nel mirino