GDUFA Self-Identification Assistance
The GDUFA Self-Identification process mandates that drug facilities, sites, and organizations involved in generic drug submissions complete an annual self-identification.
Self-identification is required for two purposes. First, it is necessary to determine the universe of facilities required to pay user fees. Second, self-identification is a central component of an effort to promote global supply chain transparency. The information provided through self identification enables quick, accurate, and reliable surveillance of generic drugs and facilitates inspections and compliance.
Under GDUFA, human generic drug facilities, sites, and organizations are required to submit identification information electronically to FDA annually. FDA is issuing this guidance to help human generic drug facilities, sites, and organizations meet the self-identification requirement.
Who Is Required to Self-Identify?- Any facility that manufactures, or intends to manufacture, human generic drug active pharmaceutical ingredients (APIs) or finished dosage forms (FDFs) — or both — must self-identify.
- Facilities responsible for packaging the finished dosage form (FDF) into its primary container/closure system, as well as those that label the primary container, are also required to self-identify.
- Certain sites, identified in a generic drug submission, may be tasked with removing a drug from its primary container/closure system and subdividing it into a different primary container/closure system. These facilities must also self-identify, particularly when they operate under a contract with the applicant.
- Sites that conduct bioequivalence (BE) or bioavailability (BA) testing for generic drugs must self-identify as well. This includes clinical BE/BA testing, bioanalytical testing of samples from clinical trials, and in vitro BE testing.
- Any site performing testing on attributes or characteristics of the finished dosage form (FDF) or active pharmaceutical ingredients (APIs) — specifically for compliance with current good manufacturing practice (CGMP) requirements — is also required to self-identify. This includes testing conducted under a contract with the drug applicant. Sites engaged in this testing are ensuring that the drugs meet necessary quality standards before they are released to the market.
This process requires these entities to provide detailed information about their identity to the FDA between May 1 and June 1 each year.
Masuu US Agent offers comprehensive support for GDUFA self-identification, including assistance with obtaining FEI and DUNS numbers and providing technical support for SPL or XML conversion.
Our services guide pharmaceutical companies through every step of the GDUFA self-identification process, ensuring compliance with FDA requirements.