Certifying Pharmaceutical Exports: An Introduction To FDA s Certificate Of Pharmaceutical Product
By Michael Cooper, Clinical and Regulatory Affairs, Pharmatech Associates
When exporting human drugs, manufacturing facilities are often asked by foreign customers or governments to provide documentation of the facility’s compliance with FDA standards. FDA issues export certificates for approved or licensed drugs and for unapproved drugs that meet certain legal requirements. Certificates of pharmaceutical product (CPP) are issued for human drugs exported from the U.S. directly to the requesting country. In Part 1 of a two-part series, we discuss the requirements for exporting U.S.-manufactured material to foreign markets leveraging a CPP issued by the FDA.