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Premarketing Safety Reporting
****On February 3, 2021 this web page indicated that as of June 28, 2021, FDA will begin accepting IND Safety Reports in E2B format. Please note that the date has been changed and FDA will post a new date for the voluntary submission of IND Safety Reports in the future. In the meantime, please continue to submit IND Safety Reports using eCTD format. E2B format will not be accepted until indicated on this web page, or until final guidance is published.****
In preparation for the receipt of IND Safety Reports, FDA has posted the following documents regarding the electronic submission of certain investigational new drug applications (INDs) safety reports for drugs and biological products to FAERS. These documents are posted to help prepare systems for electronic submissions of IND safety reports.
For investigational drugs and biological products without an established name (i.e. INN or USAN name), or if the established name exceeds established E2B character lengths, prior to submission of IND safety reports to FAERS, the sponsor should submit to the IND a general correspondence in eCTD format to inform FDA of how the product name will be submitted within the established E2B character lengths. Please refer to the Electronic Submission of IND Safety Reports – Technical Conformance Guide (October 2019) for further information.
Postmarketing Safety Reporting
FDA is modernizing the FDA Adverse Event Reporting System (FAERS). The new system will go live on November 10, 2021. For submissions made after November 10, the data elements Message Number (M.1.4 <messagenumb>) must be unique for each M.1.5 <messagesenderidentifier> which will make the combination of <messagenumb> and <messagesenderidentifier> distinct per submission in order to receive a positive acknowledgement from FAERS. FDA expects there may be some delays in the generation of the second acknowledgement between November 10, 2021 and November 20, 2021. Please continue to submit postmarketing safety reports using the current DTD 2.1 or DTD 2.2.
For assistance contact the FAERS electronic submission coordinator at faersesub@fda.hhs.gov.
This page provides drug and nonvaccine biological product manufacturers, distributors, packers, outsourcing facilities, and other interested parties with information about FDA Adverse Event Reporting System (FAERS) electronic submissions and instructions on how to electronically submit postmarketing individual case safety reports (ICSRs) with and without attachments.
Since 2000, FDA has accepted electronic submissions of both expedited and non-expedited Individual Case Safety Reports (ICSRs) for human drug and nonvaccine biologic products. To date, FDA has only accepted electronic submissions of ISCRs in the XML format, prepared in accordance with International Conference on Harmonisation-E2B (ICH E2B) (PDF – 266KB) to transmit information directly from database-to-database using standardized (ICH E2B(M)) data elements.
Starting June 10, 2015,* FDA is requiring that applicants electronically submit all ICSRs, ICSR attachments, and periodic safety reports. There are two options for submitting ICSRs electronically:
*FDA issued a final rule on June 10, 2014, that requires industry to submit post-marketing safety reports in an electronic format. See the rule at: FDA issues final rule on postmarketing safety report in electronic format (FDA Archive).
Submitting Individual Case Safety Reports (ICSRs), ICSR Attachments, & Periodic Safety Reports (PSRs)
Electronic submission of ICSRs
You have the 2 options for submitting ICSRs electronically.
ICSR Option A: Database-to-Database Transmission (“E2B”)
ICSR Option B: Safety Reporting Portal (SRP)
Applicants and non-applicants who do not have database-to-database capability may submit electronic ICSRs using the SRP. To submit via SRP, you must have an account to access the portal site. Those who are Gateway partners cannot use the SRP. Gateway partners are those companies that submit electronically via the Electronic Submission Gateway.
Steps for requesting an SRP account
SRP account activation
11/10/2021