EMA and FDA to Share Manufacturing Site Inspections
The initiative, starting in January 2012, will enable the two authorities to rely on each other's inspection outcomes rather than carrying out separate inspections in duplicate.
The European Medicines Agency and the US Food and Drug Administration (FDA) are launching an initiative to share work on inspections of manufacturing sites in each other's territories.
The initiative, starting in January 2012, will enable the two authorities to rely on each other's inspection outcomes rather than carrying out separate inspections in duplicate.
This move will enable better use of the two authorities' inspection resources; reduce the burden of inspections for medicines manufacturers; shift the authorities' inspection capacity to other regions.
The initiative will apply to inspections of manufa
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