FDA gives a number of reasons for the decision to move away from paper submissions. These include: electronic review of drug labels for compliance, elimination of data entry errors, and creation of a more efficient and effective process. If you keep in mind that the Gateway can be accessed 24 hours a day, there is the added benefit that properly-created SPL files can theoretically be processed in minutes.
To facilitate the submission of drug establishment registration and drug listing information (including labeling), FDA adopted the use of Extensible Markup Language (XML) files in the Structured Product Labeling (SPL) format. SPL is based on the Health Level Seven (HL7) version 3 Reference Information Model (RIM) and the Clinical Document Architecture (CDA). Additionally, code sets and codes are used to assist with processing, reviewing, and archiving electronic submissions. The necessary submissions to remain compliant include an Establishment Registration SPL, an NDC Labeler Code Request SPL and a Drug Listing SPL. Once the SPL file is created, it can then be submitted (uploaded) to the ESG. This includes digital certification since the submission is a secure one.
Even with the stated benefits, the electronic submissions process is arduous. SPL creation is but one hurdle to overcome. FDA actually encourages owners and operators subject to registration and listing to establish accounts (granting access to the ESG) 4-6 weeks in advance of the time to register, list, or update a registration or listing. Having knowledge of the electronic process will best ensure you’re your submissions are not delayed!
US Food and Drug Administration (FDA) now requires electronic submission for labeler code requests, drug establishment registrations, drug listings, annual renewals, and updates. The electronic process replaces FDA paper forms 2656 (Registration of Drug Establishment/Labeler Code Assignment), 2657 (Drug Product Listing), and 2658 (Registered Establishments’ Report of Private Label Distributors). To transmit files, companies must use the FDA’s Electronic Submission Gateway (ESG). According to FDA, moving from a paper-based format to an electronic system has improved the timeliness and accuracy of submissions.
This webinar will provide clarification and guidance on the process of submitting drug establishment registration and drug listing information to the FDA
Areas to be Covered:
Overview of FDA drug establishment and listing requirement
Transition from paper-based to electronic process
Creation of electronic files
Extensible Markup Language (XML)
Structured Product Labeling (SPL)
Codes and code sets
Establishing FDA Gateway (ESG) account
Submission to ESG
Checking drug establishment registration and listing status
Who will Benefit:
Regulatory Affairs professionals
QA & QC Managers
Prescription Drug manufacturers
Over-the-counter (OTC) Drug manufacturers
Active pharmaceutical ingredient (API) Drug manufacturers
Homeopathic Drug manufacturers
Medical Gas Drug manufacturers
Any individuals interested in the drug industry