This webinar has the dual purpose of highlighting the key requirements for exporting approved and unapproved drugs, and outlining the certificate of a pharmaceutical product (CPP) application process. The role CDER’s Office of Compliance plays in the export process is also discussed.
It begins with a brief history of drug export regulations, with a focus on the passage of the FDA Export Reform and Enhancement Act in 1996. The act allowed for a more simplified export notification process. Companies may export unapproved drugs to virtually anywhere. Of course, as with any regulation, there are requirements that must be met.
Unapproved new human drugs can be exported when it complies with the laws of the importing country and has marketing authorization in certain other countries. And under certain conditions, approved human drugs can be exported for unapproved uses.
When an unapproved drug is first exported, the exporter must notify FDA and continue to maintain adequate records.
A CPP is a certificate for human drug products, including human biological drugs, which conform to the World Health Organization's requirements. It also contains information about the pharmaceutical regulatory or marketing status in the US.
CPPs are requested by companies to help them qualify for importation of their product into foreign market or to receive approval, licensing, or registration of a drug abroad.
More information about the export process, regulations and record-keeping can be obtained during CDER’s webinar, “Exports,” on Wednesday, August 8, 2012 at 11 a.m. (EST).