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Worldwide Regulatory Inaction on FMD May Result in Drug Shortages

This article was originally published in The Gold Sheet

Executive Summary

There could be the potential of drug shortages in the EU unless more countries certify that drug substances made within their borders are equivalent to EU GMP standards, say pharmaceutical industry and EU health authorities. Many regulators are sitting on the sidelines and have taken no action to comply with FMD’s import provisions for active substances, which goes into effect in July.

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