News from the world
15
May
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]
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...
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...
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...
latest news
17 Jul
Inside Pharma’s Push for More Resilient Supply Chains
17 Jul
US FDA CDER plans new guidance on AI, electronic safety report submissions, and more
16 Jul
EU DG SANTE and EMA sign Working Arrangement with New Zealand Ministry of Health
15 Jul
Riforma farmaceutica. Via libera della Commissione Sanità del Senato
14 Jul
China NMPA conducts management review of QMS for regulation of vaccine and drug GMP compliance
14 Jul
AIFA: “Cerca un farmaco”: disponibili nuove informazioni sullo stato di commercializzazione dei medicinali
13 Jul
ECHA: riforma dell’Agenzia europea delle sostanze chimiche
13 Jul
US FDA Proposes Rule to Modernize Drug Manufacturing Registration