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FDA Offers New ‘cGMP Declarations’ That Could Fill US Gap In EU GMP Certificates

 
• By Bowman Cox

US FDA will send ‘cGMP declarations’ to regulatory authorities in other countries where firms want to market drug products made in the US. There is some hope that the declarations will fill in for EU GMP certificates no longer issued for US manufacturing facilities now that there is a US/EU mutual recognition agreement on inspections.

Compliance

New “cGMP declaration” letters US FDA is offering to send foreign regulatory authorities could solve problems many drug product manufacturers are having now that European authorities aren’t inspecting their US facilities.

Implementation of the March 2017 US/EU mutual recognition agreement designed to reduce duplicative inspections is going well, with the European Medicines Agency removing 60 US inspections from this year’s schedule...

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