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
2.6 Send Submissions to the Production SystemAfter completion of these steps, the Transaction Partner is enabled and approved to sendsubmissions to the FDA ESG. The Production System Account allows the Transaction Partner tosend any of the supported submission types to the FDA. However, the FDA will only processthose submission types for which the Transaction Partner has received prior approval.NOTE: It is the responsibility of the Transaction Partner to consult the appropriate FDACenter for information on formats, deadlines, and other information or procedures forsubmissions.3. Preparatory ActivitiesThere are a number of preparatory activities that need to be completed before beginning theregistration process. This section describes these preparatory activities and presents system andprotocol issues for FDA ESG users to consider.3.1 Submit Letter of Non-Repudiation AgreementA letter of Non-Repudiation Agreement must be submitted to the FDA. Reference Appendix H,Sample Letters of Non-Repudiation Agreement, for letter examples.The non-repudiation agreement allows the FDA to receive electronically signed submissions incompliance with 21 Code of Federal Regulations (CFR) Part 11.100.3.2 Obtain Digital CertificateA digital certificate must be obtained.Digital certificates ensure private and secure submission of electronic documents. The digitalcertificate binds together the owner’s name and a pair of electronic keys (a public key and aprivate key) that can be used to encrypt and sign documents.Digital certificates can be obtained from either a public or private Certificate Authority (CA). Itmust be an X.509 version 3 certificate and all data fields in the Issuer and Subject fields must becompleted. Reference Appendix C., Digital Certificates for more information on digitalcertificates.3.3 Understand Submission GuidelinesEach FDA Center has specific guidelines that must be followed for successful submission. Table1: FDA Links to Submission Preparation Guidelines below contains links to Center-specificpreparation guidelines and contacts. Table 2: Electronic Submissions Supported by the FDAESG lists electronic submissions supported by the FDA ESG. Important information on the useof digital/electronic signatures on FDA forms can be found in Appendix J., Digital Signatures.
Table 1: FDA Links to Submission Preparation GuidelinesCenterLinkCenter for Biologics Evaluation andResearch (CBER)Center for Drug Evaluation andResearch (CDER)Center for Devices and RadiologicalHealth (CDRH)Adverse Event Reporting System(AERS)Center for Veterinary Medicine (CVM)Office of the Commissioner (OC)http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/ucm163685.htmhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/default.htmhttp://www.fda.gov/ForIndustry/FDAeSubmitter/default.htmhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm115894.htmhttp://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ElectronicSubmissions/default.htmhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm114043.htmNOTE: Meeting the requirements for using the FDA ESG to route submissions does notmean that these submissions automatically meet FDA Center-specific submissionrequirements.For each test submission type, a test submission must be validated by the Center before sendingsubmissions to the Production System.It is the responsibility of the Transaction Partner to consult the appropriate FDA Center forinformation on formats, deadlines, and other information or procedures for submissions.The submission acronyms or names listed in Table 2 below are not to be used as attributes in thesubmission header. See Table G-1 in Appendix G., AS2 Header Attributes, for a list of allowedattributes for the different submission types.Table 2: Electronic Submissions Supported by the FDA ESGCenterSubmissionsAERS – Adverse Event ReportsCBERAERS AttachmentsBLA – Biologics License Application (eCTD and eBLA format)
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- Page 12 and 13: FDAPreparation of multi-filesubmiss
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- Page 16 and 17: 4. Click the Next button.The Pick a
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- 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
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- Page 39 and 40: Be sure to indicate on the applicat
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- 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
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2.6 Send <strong>Submissions</strong> to the Production SystemAfter completion of these steps, the Transaction Partner is enabled and approved to sendsubmissions to the <strong>FDA</strong> <strong>ESG</strong>. The Production System Account allows the Transaction Partner tosend any of the supported submission types to the <strong>FDA</strong>. However, the <strong>FDA</strong> will only processthose submission types for which the Transaction Partner has received prior approval.NOTE: It is the responsibility of the Transaction Partner to consult the appropriate <strong>FDA</strong>Center for information on formats, deadlines, and other information or procedures forsubmissions.3. Preparatory ActivitiesThere are a number of preparatory activities that need to be completed before beginning theregistration process. This section describes these preparatory activities and presents system andprotocol issues for <strong>FDA</strong> <strong>ESG</strong> users to consider.3.1 Submit Letter of Non-Repudiation AgreementA letter of Non-Repudiation Agreement must be submitted to the <strong>FDA</strong>. Reference Appendix H,Sample Letters of Non-Repudiation Agreement, for letter examples.The non-repudiation agreement allows the <strong>FDA</strong> to receive electronically signed submissions incompliance with 21 Code of Federal Regulations (CFR) Part 11.100.3.2 Obtain Digital CertificateA digital certificate must be obtained.Digital certificates ensure private and secure submission of electronic documents. The digitalcertificate binds together the owner’s name and a pair of electronic keys (a public key and aprivate key) that can be used to encrypt and sign documents.Digital certificates can be obtained from either a public or private Certificate Authority (CA). Itmust be an X.509 version 3 certificate and all data fields in the Issuer and Subject fields must becompleted. Reference Appendix C., Digital Certificates for more information on digitalcertificates.3.3 Understand Submission <strong>Guide</strong>linesEach <strong>FDA</strong> Center has specific guidelines that must be followed for successful submission. Table1: <strong>FDA</strong> Links to Submission Preparation <strong>Guide</strong>lines below contains links to Center-specificpreparation guidelines and contacts. Table 2: <strong>Electronic</strong> <strong>Submissions</strong> Supported by the <strong>FDA</strong><strong>ESG</strong> lists electronic submissions supported by the <strong>FDA</strong> <strong>ESG</strong>. Important information on the useof digital/electronic signatures on <strong>FDA</strong> forms can be found in Appendix J., Digital Signatures.
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