The International Council for Harmonisation has outlined ambitious plans for a technology platform it proposes to create to enable drug sponsors to submit post-marketing chemistry, manufacturing and controls (CMC) changes for evaluation by multiple regulators around the world.
Plan For Global CMC Assessment Platform Advances To Next Phase
The International Council for Harmonisation is seeking input from IT vendors on what it will take to establish a state-of-the-art technology platform that drug sponsors can use to submit quality-related post authorization submissions for collaborative assessment by multiple regulatory authorities.
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