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Bulk drug ingredient inspection harmonization likely result of U.S./EU MRA -- FDAer.

This article was originally published in The Tan Sheet

Executive Summary

BULK DRUG INTERNATIONAL INSPECTION STANDARDS LIKELY TO BE ADOPTED as a result of the U.S./European Union Mutual Recognition Agreement, FDA New Jersey District Office Director Douglas Ellsworth told a September Food & Drug Law Institute conference. Active pharmaceutical ingredient manufacturing is not now overseen by a specific authority in any European nation, Ellsworth pointed out. "We've been working with the Pharmaceutical Inspection Convention and others to come up with an international standard for active pharmaceutical ingredients, and I suspect that...will cascade into an international standard and some legislative features perhaps in the European Union," he said.

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