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U.S. Department of Health and Human Services

Drugs

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Steps to Submitting ICSRs Electronically in the XML Format

Please follow these steps to begin submitting ICSRs electronically in the XML format:

Step 1

Step 2

  • Review the following documents:
  • FDA's Guidance, Specification and DTDs - Providing Regulatory Submissions in Electronic Format - Postmarketing Safety Reports.
  • FDA's Electronic Submission Docket Memorandum for Postmarketing Safety Reporting
  • Test the SGML file to ensure compliance with ICH ICSR DTD (e.g., proper SGML syntax) using a commercial SGML parser or public domain parser. For example:  James Clark’s syntactical parser (http://www.jclark.com/sp/index.htm).
  • Validate the test file contents to ensure data structure compatibility with E2B or E2BM and AERS systems as defined in the ICH M2 ICSR Specification (e.g., field length, data type)

Step 3

  • Complete and submit the Trading Partner Information Package for both gateway and physical media submissions. To obtain a Trading  Partner Information Package (TPIP), send your electronic mail request to edigateway@oc.fda.gov.For more information, see the FDA ESG Gateway information page.
  • Submit a test file to the AERS Electronic Submissions Coordinator.
  • If test file is NOT successful, review Step 2.

Step 4

The E2B(M) IWG was established in February 2003 to enhance and harmonize the implementation of the ICH E2B(M) guideline and related M2 standards across all three regions, by allowing pharmaceutical companies, regulators and vendors, etc. to pose questions concerning the implementation of the electronic reporting of Individual Case Safety Reports (ICSRs) within the frame of the existing E2B(M) guideline and applicable M2 specifications.

Please send any questions or comments you have concerning implementation of E2B(M) to question-to-E2BM-guideline@ich.org.

Step 5

Submit ICSRs through the gateway during the gateway hours of operation. 

For more information regarding Gateway status and Frequently Asked Questions see the ESG Gateway page.

The gateway will return an acknowledgment of receipt of the transmission when each transmissions is successfully received and decrypted.  The AERS system will return an ICH M2 compliant acknowledgment message when the ICSRs have been processed.