FDA Electronic Regulatory Filings Submission – Drug Establishment Registrations and Drug Listings

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This webinar will provide clarification and guidance on the process of submitting drug establishment registration and drug listing information to the FDA.

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.

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). Having knowledge of the electronic process from this webinar will best ensure your submissions are not delayed!

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
Project Managers
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

Camille Davis Thornton, M.S., RAC is the founder of MACE Concepts, LLC, an independent consultancy specializing in providing innovative regulatory, compliance, and training solutions. Ms. Thornton has an M.S. in Biotechnology from The Johns Hopkins University and certifications from the Regulatory Affairs Professionals Society (RAC-US) and the National Restaurant Association (ServSafe® Food Protection Manager, Instructor, and registered Examination Proctor). Additionally, she has over 15 years of experience in multiple regulated industries and actively teaches at the college level.

Ms. Thornton’s areas of expertise include regulatory filings, the FDA Electronic Submissions Gateway (ESG), and liaising with government agencies. Also known as the “Perpetual Inquisitive Geek”, she regularly reviews applicable guidance documents, notifications, newsletters, blog postings, and email alerts from various government agencies to stay up-to-date with current requirements and industry trends. Ms. Thornton is a regulatory affairs professional and trainer with a true passion for sharing knowledge effectively.

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