EU and U.S. Developing New Approaches to Prevent Drug Shortages
This article was originally published in The Gold Sheet
Executive Summary
A UK MHRA official said there is a “regulatory dilemma” between meeting GMP enforcement obligations and preventing drug shortages. New changes in the EU GMP Guide aim to take a more proactive approach to drug shortages by requiring early notification by manufacturers, while in the U.S. a new drug shortage prevention program called the Accelerated Recovery Initiative (ARI) is finally getting off the ground.
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