The FDA now offers cGMP Declarations

The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Export Certificate office, a new online application. The online application makes it possible to request a cGMP Declaration (Current Good Manufacturing Practice).

A cGMP Declaration can be issued by the FDA to a foreign regulator, such as the competent authorities of an EU Member State. The declaration issued by the FDA is intended to confirm the current cGMP US compliance status for the requesting establishment.

Establishments physically located in the U.S. can use the FDA’ online application process Before requesting a cGMP Declaration, a Certificate of Pharmaceutical Product (CPP) must be obtained. CPP are the only export certificates issued by the FDA. They are issued for drugs typically exported from the U.S. directly to the requesting country.

This is a useful tool in the context of the mutual recognition between the FDA and the European Medicines Agency (EMA) of March 2017. This agreement permits recognition by each Agency of the other’s inspection outcomes. The competent national authorities of EU Member States issue Good Manufacturing Practice certificates within after a manufacturing site inspection. The GMP certificates are uploaded into the EudraGMDP database.

Back to main blog
Loading data