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European Commission Proposes to Ease Variations Process for Manufacturing Changes

This article was originally published in The Gold Sheet

Executive Summary

CHANGE IS IN THE AIR with the European Commission proposing to simplify and further harmonize the EU variations regulation to ease the global manufacturing change process. The commission would impose a community-wide approach that adds easier “do and tell” procedures for minor variations, includes the ICH design space concept and converges with FDA’s evolving supplement filing process, which will also become easier under a guidance that agency is drafting.
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