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U.S. Department of Health and Human Services

For Industry

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Generic Drug Facility Electronic Self-Identification

FDA is establishing databases, systems, and processes that help generic drug companies perform electronic self-identification of facilities and sites involved in the development and manufacturing of generic drugs. Electronic self-identification is requested by all such facilities and sites, whether or not user fees payments are required and if the facilities and sites are identified or intended to be identified in an approved or pending generic drug submission.

In support of Generic Drug Facility Electronic Self-Identification, including the annual establishment of generic drug user fees and future inspections goals, FDA will leverage the Electronic Submissions Gateway (ESG) and the electronic Drug Registration and Listing System (eDRLS). Self-identification will not replace the ESG or eDRLS processes; these processes will continue as they currently exist. To this point, self-identification entails additional processes that also utilize XML file formats which conform to Health Level Seven (HL7) message exchange standards for Structured Product Labeling (SPL), versions 4 and 5. Similar to eDRLS processes, self-identifiers can generate SPL files using FDA’s eSubmitter tool. Alternatively to eSubmitter, users may create SPL files based on XForms technology. You can access the XForms via the SPL Xforms web page.

SPL GDUFA files must be submitted through FDA’s ESG. The technical details for utilizing SPL files are available in the SPL Implementation Guide.

For more information about the creation of the SPL Industry Information, please see the GDUFA Guidance Documents page.

IMPORTANT! To submit your file to the FDA, you must first obtain a WebTrader account with the FDA Electronic Submission Gateway (ESG). To do this, visit the Setting up a WebTrader Account Checklist.