EU To Defer US GMP Inspections Ahead Of Mutual Recognition Agreement Becoming Operational In November

EU inspectorates are putting off their plans to undertake any good manufacturing practice inspections in the US wherever possible, in anticipation of the EU-US mutual agreement coming into force in November.

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EU Is Putting Off US GMP Inspections Ahead Of Mutual Reliance Agreement • Source: Shutterstock

The European Medicines Agency says it will make efforts to defer any good manufacturing practice inspections in the US in anticipation of the EU-US mutual recognition agreement coming into operation from Nov. 1 onwards. The agreement, when operational, will allow drug regulators in the two regions to rely on each other’s GMP inspections conducted within their respective territories.

The EMA told the Pink Sheet that the “EU inspectorates will be making maximum use of existing EU procedures to defer inspections, where possible, in anticipation of the operational phase of the MRA that starts in November 2017”. (Also see "US Reliance On EU Drug Facility Inspections Begins In November" - Pink Sheet, 5 May, 2017

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