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

Duration: 60 Minutes
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 on the process of submitting drug establishment registration and drug listing information to the FDA.
online filing system
Product ID: 500254

Why Should you Attend:
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 your submissions are not delayed!

Learning Objectives:
  • Have a much better understanding of the electronic submission process for drug establishment registrations and drug listings
  • Know key concepts including XML, SPL, and ESG
Objectives of the Presentation:
  • 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 can Benefit:
This webinar will provide valuable assistance to:
  • Regulatory Affairs Professionals
  • Project Managers
  • QA & QC Managers
  • Drug manufacturers including prescription, over-the-counter (OTC), active pharmaceutical ingredient (API), homeopathic, and medical gas
  • Consultants
  • Any individuals interested in the drug industry
$375
Recorded Session for one participant
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Instructor Profile:
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 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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