Electronic Submissions
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This document summarizes a presentation about US FDA regulation updates regarding electronic submissions. It discusses the FDA Electronic Submission Gateway (ESG), which provides a single entry point for securely submitting electronic documents. The ESG aims to automate processes, support electronic submissions in a standard format, and route submissions to the appropriate FDA center. The presentation also covers FDA initiatives for electronic submissions for drugs, biologics, devices, and other product types. It provides information on how to set up for electronic submissions using the ESG.
Electronic Submissions
- 1. US FDA Regulation UpdateElectronic SubmissionsPresented by John Beasley
- 2. TopicsElectronic SubmissionsFDA Electronic Submission Gateway (ESG)CDRH initiativeseSubmitter / WebTrader SoftwareVideo
- 3. Introduction
- 5. IntroductionDrugs (Regulated by CDER) - Over-the-Counter medications- Prescription Drugs- Generic DrugsBiologics (Regulated by CBER) - Vaccines- Blood- Gene TherapiesFood & Cosmetics (Regulated by CFSAN)- Food products (excluding meat)- Food additives (colors, fortifications, radiation)- Dietary Supplements- Bottled Water- Food packaging and labeling- CosmeticsMedical Devices (Regulated by CDRH) - Wheelchairs- Bandages- Contact Lenses- Prosthetic Limbs- MRI MachinesRadiation-Emitting Products (Regulated by CDRH) - Microwave Ovens- Televisions- Medical X-ray machines- Baggage X-ray machinesVeterinary Products (Regulated by CVM) - Livestock Feed- Pet Food- Animal Drugs
- 6. Electronic Submissions1997 ¨C Computer Assisted New Drug Applications2001 ¨C Providing Regulatory eSubmissions for NDAs, BLAs, ANDAs2007 ¨C CDRH e-copy initiatives; turbo 510(k) for IVD products2011 ¨C eMDR (21 CFR 803)
- 7. Electronic SubmissionsSTDM ¨C statistical time division multiplexingHL7 ¨C standards for interoperability of health information technology
- 8. Electronic SubmissionsFDA Electronic Submission GatewayFederal Register: August 8, 2006 (Volume 71, Number 152)A single point of entry for receiving and processing all electronic submissions in a highly secure environment,Automating current processes such as the electronic acknowledgment of submissions, andSupporting the electronic Common Technical Document (eCTD).
- 11. Electronic Submission21 CFR 33321 CFR 880.6890
- 12. Electronic Submissions GatewayReceiptmeans transfer of a submission from a sender¡¯s system to a temporary storage area in the GATEWAY (FDA ESG).Acknowledgmentto the sender that the submission was sent from the sender¡¯s system and received by the Gateway.Routingrefers to delivering a submission to a Center-level storage area and initiating a load process to place a submission into a Center receiving systemNotificationof a submission¡¯s arrival is made to those individuals responsible for the Center¡¯s receiving system.
- 13. Electronic Submissions GatewayThe Gateway is a conduit, or "highway", along which submissions travel to reach their final destination.
- 14. Electronic Submissions Gateway Six to eight weeks to setup
- 15. Less expensive
- 16. Greater accuracy
- 17. Fast
- 18. Better evidenceWhat¡¯s in it for you?CollaborationCost reductionRecord retentionResponsivenessSingle environment for all AE
- 20. FDA¡¯s Electronic Submission GatewayLetter of non-repudiationDUNS numberDigital certificatePrepare electronic submissionSet up the computerLetter of Non-repudiationAS2 Gateway to GatewayESGDigital certificateeSubmitter & WebTrader
- 21. US FDA Webinar ¨C June 2011