News about GMP/cGMP


FDA introduces cGMP Declarations

On September 17, the US FDA announced a new online application, cGMP declarations. FDA's CDER will send ‘cGMP declarations’ to regulatory authorities in other countries where US firms want to market drug products.

Upon receipt of a written or email request by an establishment physically located in the US that has been included as part of a marketing application submitted to a foreign regulator, FDA will issue within 30 days of receipt of the request, a written communication to an identified foreign regulator conveying the current cGMP compliance status for the establishment making the request.


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