‘Global Allegiance’ of Inspectorates Emerging
This article was originally published in The Gold Sheet
Executive Summary
Drug regulatory agencies around the world are beginning to coordinate their inspection processes, which could reduce global drug manufacturers’ burden of hosting multiple GMP inspections.Some are piloting joint inspections, with a pilot for active pharmaceutical ingredient manufacturers concluding next month, and a second for drug product manufacturers under way.
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Mutual Reliance Blossoming Among U.S. FDA, EMA, Other Inspectorates
U.S. FDA, EMA and other agencies are increasingly relying on each others' inspection results in an effort to spread their inspectional resources throughout the furthest corners of the globe.
Mutual Reliance Blossoming Among FDA, EMA, Other Inspectorates
FDA, EMA and other agencies are increasingly relying on each others' inspection results in an effort to spread their inspectional resources throughout the furthest corners of the globe. Inspection coordination remains somewhat ad hoc, with EMA keeping a spreadsheet for some and PIC/S enabling others. EMA's EudraGMP database is touted as a coordination hub.