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        Guidance, Compliance, & Regulatory Information

Human Drug Exports

                        
                Electronic Certificates of Pharmaceutical Product: General Information
          Human Drug Export Certificate Application Instructions
          Modernization of the FDA CDER Export Certificate Program
          Online Verification of eCPPs for Human Drug Products
          Interpreting Why FDA Returned Your Electronic Certificate of Pharmaceutical Product Application Home
          Drugs
          Guidance, Compliance, & Regulatory Information
          Human Drug ExportsGuidance, Compliance, & Regulatory Information Human Drug Exports
  	
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    PrintFDA works to promote and protect the public health by promoting supply chain integrity of human drug exports. Companies exporting drugs from the U.S. as well as foreign regulatory authorities frequently ask FDA to supply an export certificate for products regulated by the FDA.

FDA issues certificates of pharmaceutical product (CPP) and current good manufacturing practice (CGMP) declarations for human drugs. See the human drugs exports flyer for more information.

Export guidance and additional information

Exports Under the FDA Export Reform and Enhancement Act of 1996 Guidance
	FDA Export Certificate Guidance
	Hemispherx export letterCPP information

CPPs provide information about the drug’s U.S. marketing status and the manufacturer’s compliance with quality manufacturing requirements. Companies request CPPs to help qualify their product for importation into a foreign market or to receive approval, licensing or registration of the drug abroad. CPP applications may be submitted using our online platform.

The FDA Center for Drug Evaluation and Research (CDER) previously issued foreign exported CPPs for FDA-approved drugs and biologics that were exported from a country other than the United States. Now CDER does not issue foreign exported CPPs given the other resources available for stakeholders to verify whether a drug or biologic is FDA approved and to view FDA’s classifications of its inspections of manufacturing facilities. See CPPs for more information.

Starting on Dec. 3, 2021, CDER will begin issuing electronic Certificates of Pharmaceutical Product (eCPPs) and will no longer issue or mail paper CPPs. CPP applications received prior to Dec. 3, 2021, will be issued a paper certificate. Please read FDA’s announcement on modernizing CDER’s export certificate program for more details on this important change which will result in a more efficient process for issuing export certificates.

CGMP declarations information

FDA issues letters, called CGMP declarations, to foreign regulators to convey the CGMP compliance status of manufacturing facilities located in the U.S. The status is based on FDA’s most recent inspection. These letters help streamline other regulatory authorities’ need to reinspect facilities in the U.S. Foreign regulators can also find the inspection classification of an establishment by checking the inspection classification database. A CGMP declaration should only be requested if a foreign regulator does not accept a valid certificate of pharmaceutical product (CPP) and wants additional assurance of a facility’s CGMP status.

CDER electronic certificate application and tracking system (CDEReCATS)

CDER has an electronic system called CDER export certification and tracking system (CDEReCATS) which allows users to request a CPP or CGMP declaration online. See the application guide for step-by-step instructions on how to use CDEReCATS to request an export certificate.

Contact

Contact CDERexportcertificateprogram@fda.hhs.gov with questions about export certificates. See human drug imports for information on importing drugs to the U.S.

                                                                                  Content current as of:
      08/19/2022
                  
                   
Regulated Product(s)
		 DrugsHuman Drug Exports                
                          

                        Electronic Certificates of Pharmaceutical Product: General Information
          Human Drug Export Certificate Application Instructions
          Modernization of the FDA CDER Export Certificate Program
          Online Verification of eCPPs for Human Drug Products
          Interpreting Why FDA Returned Your Electronic Certificate of Pharmaceutical Product Application
 
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