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 agreement 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 90 days after a manufacturing site inspection. The GMP certificates are uploaded into the EudraGMDP database.
Authored by Elisabethann Wright and Alexander Wenzel