Mutual Reliance Blossoming Among U.S. FDA, EMA, Other Inspectorates
This article was originally published in PharmAsia News
Executive Summary
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.
You may also be interested in...
The Anti-Falsification Directive: Europe’s Answer to Global Supply Chain Threats
The European Union July 1 published its directive on falsified medicines, setting into motion a tightening of Europe’s pharmaceutical supply chain that will for the most part take place over the next 18 months – and that could cost pharmaceutical companies billions of Euros.
‘Global Allegiance’ of Inspectorates Emerging
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.
‘Shadow’ Factory Challenges Continue For US FDA
Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy’s plant and seeks to find disappearing manufacturer of contaminated OTC eye drops.