“Cheap China drugs” paradigm turned on its head; EMA disagrees with FDA on Ranbaxy site; Apotex API site fails FDA test; Drug tracing will mean cheaper recalls.
Sagent's China plant stems shortages of cheap American drugs
It appears Sagent Pharmaceuticals Inc. has turned the "cheap China drugs" paradigm on its head.
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Amid the wait for an action plan to apply AI tools to drug regulation at the national level in China, capital city Beijing has released its own vision of scenarios for the technology in the healthcare sector.
China has announced a raft of new measures to encourage innovative drug development across the product life cycle, including using insurance data to differentiate new therapies and applying commercial insurance to selected novel products.
FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.
At this year’s DIA China meeting, the national regulator updated its policy focus areas for this year, including clinical trial data protection and pilot projects to shorten IND approval times.
