Description : 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! Areas Covered in the Session : Overview of FDA drug establishment and listing requirementTransition from paper-based to electronic processCreation of electronic filesExtensible Markup Language (XML)Structured Product Labeling (SPL)Codes and code setsEstablishing FDA Gateway (ESG) accountSubmission to ESGChecking drug establishment registration and listing status Who Will Benefit: Regulatory Affairs professionalsProject ManagersQA & QC ManagersPrescription Drug manufacturersOver-the-counter (OTC) Drug manufacturersActive pharmaceutical ingredient (API) Drug manufacturersHomeopathic Drug manufacturersMedical Gas Drug manufacturersConsultantsAny individuals interested in the drug industry