Under GDUFA, human generic drug facilities, sites, and organisations are required to submit identification information electronically to FDA annually. The reporting period for the fiscal year 2018 is between May 1st and June 1st of 2017.
Structured Product Labeling (SPL) is the standard that FDA intends to use for the exchange of drug establishment registration and drug listing information. The SPL file should be created following the FDA technical specifications and it should be submitted to FDA through the Electronic Submissions Gateway (ESG).
Please refer to Guidance for Industry: Self-Identification of Generic Drug Facilities, Sites, and Organizations, that explains who is required to self-identify, what information is required for submission, and what the process is for submitting self-identification information.
ASPHALION has extensive experience in SPL generation and electronic submission. If you need any support to comply with the self-identification requirement, please contact us: [email protected]
