FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc
FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc
processed by the FDA ESG. FDA strongly encourages Transaction Partners tosend test submissions comprised of PDF files and SAS transport files.- Send submissions greater than 7.5 GB in size overnight. Pilot testing with selectedIndustry Transaction Partners has shown that, depending on available bandwidth, ittakes approximately 24 hrs for submissions 15 GB to 25 GB in total size to betransmitted and processed by the FDA ESG. These companies had T3 networkconnections or better. FDA recommends that large submissions be sent overnight,starting at 4:30 PM EST, in order for the submission to be received by the targetCenter before the end of the next business day.Sending large submissions may result in the FDA ESG erroneously reporting that thetransmission was not successful, even though the FDA ESG has successfully received thetransmission. This is a known bug and FDA has asked Cyclone Commerce to provide an updateto that fixes this error.When the FDA ESG has received a complete submission, a backup copy is made before a replyfrom the FDA ESG is sent confirming the submission is complete. For large submissions (> 7.5GB), this can take many minutes. Since there is no network activity for such a long time, thesession timeouts and a response is not received. The FDA ESG has received the submissionsuccessfully, but an error is generated indicating that the submission needs to be resumed.Receipt of the first acknowledgement (MDN) confirms that the submission was successfullyreceived by the FDA ESG and that it is okay to cancel the resume request. Since this is a largesubmission, it will take several hours before the first acknowledgement is received.If you receive this error and it has clearly occurred at the end of the transmission, do not resendthe submission right away. Wait for several hours (or longer depending on the size of thesubmissions) and see if the MDN is sent before attempting to resend the submission.5.8 Common AS2 ErrorsHere are some of the most common causes of failed AS2 submissions:- Your firewall rules are not set to allow connections with the FDA over port 4080.The FDA requires that all communications with the ESG occur with HTTPS overport 4080.- You provide a private URL during registration. (A private URL is one locatedinside of your company's firewall.)- The submissions's message header does not contain custom attributes.We recommend two strategies to avoid these errors:- Work with your IT infrastructure team throughout the registration process. Makesure they are aware of specific security settings that need to be enabled forsuccessful AS2 registration and transmission.
- Create a local environment that simulates the FDA to test your submissions beforeyou actually connect to the FDA. Trading partners who test locally have a muchhigher rate of success than those who don't.Contact esgreg@gnsi.com if you have any problems with your registration or submissions.6. References/ResourcesThe following table provides some additional references and resources related to electronicsubmissions and the FDA ESG.Table 6: Additional ReferencesDocumentCBER Annual ReportElectronic Regulatory Submissionsand ReviewElectronic Submissions through theFDA ESTRI GATEWAY FrequentlyAsked Questions (FAQ)FDA AERS Electronic SubmissionsWeb SiteGuidance for Industry Part 11,Electronic Records; ElectronicSignatures - Scope and ApplicationGuidance for Industry: ProvidingRegulatory Submissions in ElectronicFormat – NDAs and ANDAsGuidance for Industry: ProvidingRegulatory Submissions in ElectronicFormat - Postmarketing ExpeditedSafety ReportsGuidance for Industry: ProvidingRegulatory Submissions to CBER inElectronic Format - InvestigationalNew Drug Applications (INDs)Guidance for Industry: ProvidingRegulatory Submissions in ElectronicFormat - General ConsiderationsWeb Linkhttp://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm122930.htmhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM085361http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm114807.htmhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm115894.htmhttp://www.fda.gov/cder/guidance/5667fnl.htmhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072322.pdfhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072369.pdfhttp://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/General/UCM150028.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm124751.pdf
- Page 1 and 2: FDA Electronic Submissions Gateway
- Page 3: Appendix C. Digital Certificates...
- Page 6 and 7: Figure 1: Overview of the Registrat
- Page 8 and 9: 2.6 Send Submissions to the Product
- Page 10 and 11: eCTD - Electronic Common Technical
- Page 12 and 13: FDAPreparation of multi-filesubmiss
- Page 14 and 15: 3.7 Help and InformationThere are r
- Page 16 and 17: 4. Click the Next button.The Pick a
- Page 18: 8. Click the Next button.The Locate
- Page 21 and 22: 14. Enter a new login User ID and P
- Page 23 and 24: Confirm that the correct version of
- Page 25 and 26: 7. Select the Send document menu it
- Page 27 and 28: - Load tests ensure that you are ab
- Page 29 and 30: 20. To access the receipt, click on
- Page 31 and 32: 4.4 Apply for a Production System A
- Page 33 and 34: submissions (> 7.5 GB), this can ta
- Page 35 and 36: When a Center receives a submission
- Page 37 and 38: The following information is requir
- Page 39: Be sure to indicate on the applicat
- Page 43 and 44: ___________________________________
- Page 45 and 46: Upon receiving the file, signature
- Page 47 and 48: or by obtaining a certificate from
- Page 49 and 50: 3. Click on the Export button to cr
- Page 51 and 52: 9. Give a file name and select the
- Page 53 and 54: 4. Create a password for your priva
- Page 55 and 56: 2. Select "Windows" from the platfo
- Page 57 and 58: 2. Click on the link under Required
- Page 59 and 60: 4. With the box unchecked, a warnin
- Page 61 and 62: . From the Add or Remove Programs d
- Page 63 and 64: Appendix E. Glossary of TermsTable
- Page 65 and 66: Appendix F. AcronymsA list of acron
- Page 67 and 68: Table G-1: Allowable Center Attribu
- Page 69 and 70: SAMPLE LETTER #1[Company Letterhead
- Page 71 and 72: EDIFACT UNB Header InformationDescr
- Page 73 and 74: Consult with an FDA Center represen
- Page 75 and 76: Figure 3: File System Settings, Dir
- Page 77 and 78: 6. Click on the Save changes button
- Page 79 and 80: Figure 7: Submission Types Supporte
- Create a local environment that simulates the <strong>FDA</strong> to test your submissions beforeyou actually connect to the <strong>FDA</strong>. Trading partners who test locally have a muchhigher rate of success than those who don't.Contact esgreg@gnsi.com if you have any problems with your registration or submissions.6. References/ResourcesThe following table provides some additional references and resources related to electronicsubmissions and the <strong>FDA</strong> <strong>ESG</strong>.Table 6: Additional ReferencesDocumentCBER Annual Report<strong>Electronic</strong> Regulatory <strong>Submissions</strong>and Review<strong>Electronic</strong> <strong>Submissions</strong> through the<strong>FDA</strong> ESTRI GATEWAY FrequentlyAsked Questions (FAQ)<strong>FDA</strong> AERS <strong>Electronic</strong> <strong>Submissions</strong>Web SiteGuidance for Industry Part 11,<strong>Electronic</strong> Records; <strong>Electronic</strong>Signatures - Scope and ApplicationGuidance for Industry: ProvidingRegulatory <strong>Submissions</strong> in <strong>Electronic</strong>Format – NDAs and ANDAsGuidance for Industry: ProvidingRegulatory <strong>Submissions</strong> in <strong>Electronic</strong>Format - Postmarketing ExpeditedSafety ReportsGuidance for Industry: ProvidingRegulatory <strong>Submissions</strong> to CBER in<strong>Electronic</strong> Format - InvestigationalNew Drug Applications (INDs)Guidance for Industry: ProvidingRegulatory <strong>Submissions</strong> in <strong>Electronic</strong>Format - General ConsiderationsWeb Linkhttp://www.fda.gov/About<strong>FDA</strong>/CentersOffices/CBER/ucm122930.htmhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/<strong>Electronic</strong><strong>Submissions</strong>/UCM085361http://www.fda.gov/ForIndustry/<strong>Electronic</strong><strong>Submissions</strong><strong>Gateway</strong>/ucm114807.htmhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm115894.htmhttp://www.fda.gov/cder/guidance/5667fnl.htmhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072322.pdfhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072369.pdfhttp://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/General/UCM150028.pdfhttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm124751.pdf
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