Electronic Submissions

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My presentation on eSubmissions and eMDR Proposed Rule at Medtec China 2011

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Electronic Submissions

  1. 1. US FDA Regulation Update<br />Electronic Submissions<br />Presented by John Beasley<br />
  2. 2. Topics<br />Electronic Submissions<br />FDA Electronic Submission Gateway (ESG)<br />CDRH initiatives<br />eSubmitter / WebTrader Software<br />Video<br />
  3. 3. Introduction<br />
  4. 4. Introduction<br />便宜<br />但好<br />
  5. 5. Introduction<br />Drugs (Regulated by CDER) <br />- Over-the-Counter medications<br />- Prescription Drugs<br />- Generic Drugs<br />Biologics (Regulated by CBER) <br />- Vaccines<br />- Blood<br />- Gene Therapies<br />Food & Cosmetics (Regulated by CFSAN)<br />- Food products (excluding meat)<br />- Food additives (colors, fortifications, radiation)<br />- Dietary Supplements<br />- Bottled Water<br />- Food packaging and labeling<br />- Cosmetics<br />Medical Devices (Regulated by CDRH) <br />- Wheelchairs<br />- Bandages<br />- Contact Lenses<br />- Prosthetic Limbs<br />- MRI Machines<br />Radiation-Emitting Products (Regulated by CDRH) <br />- Microwave Ovens<br />- Televisions<br />- Medical X-ray machines<br />- Baggage X-ray machines<br />Veterinary Products (Regulated by CVM) <br />- Livestock Feed<br />- Pet Food<br />- Animal Drugs<br />
  6. 6. Electronic Submissions<br />1997 – Computer Assisted New Drug Applications<br />2001 – Providing Regulatory eSubmissions for NDAs, BLAs, ANDAs<br />2007 – CDRH e-copy initiatives; turbo 510(k) for IVD products<br />2011 – eMDR (21 CFR 803)<br />
  7. 7. Electronic Submissions<br />STDM – statistical time division multiplexing<br />HL7 – standards for interoperability of health information technology<br />
  8. 8. Electronic Submissions<br />FDA Electronic Submission Gateway<br />Federal Register: August 8, 2006 (Volume 71, Number 152)<br />A single point of entry for receiving and processing all electronic submissions in a highly secure environment,<br />Automating current processes such as the electronic acknowledgment of submissions, and<br />Supporting the electronic Common Technical Document (eCTD).<br />
  9. 9. Electronic Submissions<br />
  10. 10. Electronic Submissions<br />A<br />D<br />V<br />E<br />R<br />S<br />E<br />E<br />V<br />E<br />N<br />T<br />S<br />
  11. 11. Electronic Submission<br />21 CFR 333<br />21 CFR 880.6890<br />
  12. 12. Electronic Submissions Gateway<br />Receiptmeans transfer of a submission from a sender’s system to a temporary storage area in the GATEWAY (FDA ESG).<br />Acknowledgmentto the sender that the submission was sent from the sender’s system and received by the Gateway.<br />Routingrefers to delivering a submission to a Center-level storage area and initiating a load process to place a submission into a Center receiving system<br />Notificationof a submission’s arrival is made to those individuals responsible for the Center’s receiving system.<br />
  13. 13. Electronic Submissions Gateway<br />The Gateway is a conduit, or "highway", along which submissions travel to reach their final destination. <br />
  14. 14. Electronic Submissions Gateway<br /><ul><li> Six to eight weeks to setup
  15. 15. Less expensive
  16. 16. Greater accuracy
  17. 17. Fast
  18. 18. Better evidence</li></li></ul><li>What’s in it for you?<br />Collaboration<br />Cost reduction<br />Record retention<br />Responsiveness<br />Single environment for all AE<br />
  19. 19. Preparing for ESG<br />胆小或大胆<br />
  20. 20. FDA’s Electronic Submission Gateway<br />Letter of non-repudiation<br />DUNS number<br />Digital certificate<br />Prepare electronic submission<br />Set up the computer<br />Letter of Non-repudiation<br />AS2 Gateway to Gateway<br />ESG<br />Digital certificate<br />eSubmitter & WebTrader<br />
  21. 21. US FDA Webinar – June 2011<br />

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