Specifications for Preparing and Submitting  
Electronic ICSRs and ICSR Attachments 
 
 
Technical Specifications Document 
 
 
Associated Guidance Documents and Conformance Guide: 
Draft Guidance for Industry: Providing Submissions in Electronic Format  
Postmarketing Safety Reports (June 2014) 
Guidance for Industry and FDA Staff: Postmarketing Safety Reporting for 
Combination Products (July 2019) 
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic 
Format: IND Safety Reports (October 2019)  
Electronic Submissions of IND Safety Reports Technical Conformance Guide 
(October 2019) 
 
For questions regarding this technical specifications document, contact the Office of Surveillance 
and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, at 
FAERSESUB@fda.hhs.gov; or Office of Communication, Outreach and Development, Center 
for Biologics Evaluation and Research, Food and Drug Administration, at 
CBERICSRSubmissions@fda.hhs.gov. 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
    April 2021 
Draft Version 1.9                      1  Specifications for Preparing and Submitting 
Electronic ICSRs and ICSR Attachments 
Revision History Table 
Date  Version  Summary of Changes 
2008-06-11  1.0  Initial Version 
2008-08-06  1.1  Added Filename format information 
2008-10-10  1.2  Updated UTF-8 to ISO-8859-1 encoding; indicated 
simultaneous acceptance of ICSR and ICSR 
attachments; provided another acceptable file 
extension for SGML files; and clarified use of 
abbreviations (NDA, ANDA, and STN) 
2008-10-22  1.3  Provided clarification in Section II; updated footnote 
3; and added new paragraph to Section V.C. 
2013-07-05  1.4  Updated AERS to FAERS migration changes, 
removed references to SGML file formatting, 
incorporated updates from CBER 
2018-02-06  1.5  Added a new section to highlight data fields for 
reporting ICSRs on Combination Products 
2019-09-30  1.6  Added two new sections to provide regional data 
elements for electronic submissions of certain IND 
safety reports (section I) and IND-exempt 
Bioavailability (BA)/Bioequivalence (BE) studies 
(section J). 
Added an appendix (II) highlighting various case 
scenarios for electronic submissions of IND safety 
reports to FAERS.  
 
 
 
 
 
 
Draft Version 1.9                      2 
 
  2020-02-11  1.7  Added a new value to the data element B.4.k.1 for 
drug characterization to accommodate a similar 
device. 
Updated the data element B.4.k.18.2 to specify 
values. 
Updated the data element B.4.k.18.3 to use default   
value. 
2020-12-18  1.8  Added a new regional data element 
A.1.FDA.16 (FDA Safety Report Type) in 
Table 2 Detailed Description of 
Administrative Tags 
Added section Submission Rules  
Added a new value to the data element 
B.4.k.1 and B.4.k.19 in section J. IND-
exempt BA/BE Studies   
2021-03-26  1.9  Updated section XML Header to include 
DTD 3.0 for premarketing reporting 
Updated the reference description to data 
element A.1.FDA.16 in Table 2 Detailed 
Description of Administrative Tags 
Updated section ICSR Message Header 
Information to include information in 
premarketing reporting 
Updated section AS2 Headers and Routing 
IDs for Premarketing Safety Report 
Submissions 
Updated section Submission Rules 
 
   
Draft Version 1.9                      3  Specifications for Preparing and Submitting 
Electronic ICSRs and ICSR Attachments 
Table of Contents 
I.  ELECTRONIC SUBMISSIONS OF ICSRS AND ICSR ATTACHMENTS ................. 6 
II.  SUBMISSION FILE NAME .......................................................................................... 7 
III. ICSR ACKNOWLEDGEMENTS .................................................................................. 7 
A.  ESG ACKNOWLEDGEMENT ............................................................................................. 7 
B.  FAERS ACKNOWLEDGMENT .......................................................................................... 7 
IV. ELECTRONIC TRANSPORT FORMAT:  XML FILES.............................................. 7 
A.  AS2 HEADERS AND ROUTING IDS FOR POSTMARKETING SAFETY REPORT SUBMISSIONS .... 8 
B.  AS2 HEADERS AND ROUTING IDS FOR PREMARKETING SAFETY REPORT SUBMISSIONS....... 8 
C.  XML HEADER ............................................................................................................... 9 
D.  ICSR MESSAGE HEADER INFORMATION ........................................................................ 10 
E.  ICSR FILE EXTENSION ................................................................................................. 10 
V.  DATA ELEMENTS FOR ELECTRONIC SUBMISSIONS ........................................ 10 
A.  MINIMUM DATA ELEMENTS REQUIREMENTS.................................................................. 10 
B.  ADMINISTRATIVE AND IDENTIFICATION ELEMENTS ........................................................ 11 
C.  AUTHORIZATION/ APPLICATION NUMBER FORMAT......................................................... 12 
D.  UNIQUE CASE IDENTIFICATION NUMBERS FOR INITIAL AND FOLLOW-UP ICSRS .............. 13 
E.  MEDDRA SPECIFIC ELEMENTS ..................................................................................... 13 
1.  Reaction/Event ........................................................................................................ 14 
2.  Other E2B Elements................................................................................................. 14 
F.  DRUG DESCRIPTION AND CASE NARRATIVE ELEMENTS .................................................. 15 
1.  Recording Multiple Drugs ........................................................................................ 15 
2.  Medicinal Product Name and Active Drug Substance Name ...................................... 15 
3.  Case Narrative ........................................................................................................ 16 
G.  OTHER DATA ELEMENTS .............................................................................................. 16 
1.  Dosage Information Field ........................................................................................ 16 
2.  Pharmaceutical Form Field ..................................................................................... 16 
3.  Route of Administration Field .................................................................................. 16 
4.  Receiver Field (A.3.2) .............................................................................................. 16 
5.  Message Receiver Field (M.1.6) ............................................................................... 17 
H.  DATA ELEMENTS FOR ELECTRONIC SUBMISSIONS OF SAFETY REPORTS FOR 
POSTMARKETING COMBINATION PRODUCTS ......................................................................... 17 
Draft Version 1.9                      4  I.  DATA ELEMENTS FOR ELECTRONIC SUBMISSIONS OF IND SAFETY REPORTS.................... 28 
J.  DATA ELEMENTS FOR ELECTRONIC SUBMISSIONS OF ICSRS FROM IND-EXEMPT 
BIOAVAILABILITY (BA)/ BIOEQUIVALENCE (BE) STUDIES..................................................... 35 
VI. ELECTRONIC FORMAT FOR ICSR ATTACHMENTS .......................................... 38 
A.  CONVERTING THE ICSR ATTACHMENT TO PDF ............................................................. 38 
B.  IDENTIFICATION INFORMATION IN THE PDF DOCUMENT INFORMATION FIELDS ................ 38 
VII. SUBMISSION RULES ................................................................................................. 39 
APPENDIX I. EXAMPLES OF CORRECT AND INCORRECT APPLICATION 
NUMBER AND DRUG ELEMENT FORMATS ................................................................ 41 
APPENDIX II. CASE SCENARIOS FOR IND SAFETY REPORTS SUBMITTED TO 
FAERS ................................................................................................................................. 43 
APPENDIX III. CASE SCENARIOS FOR SAFETY REPORTS FROM IND-EXEMPT 
BA/BE STUDIES TO FAERS ............................................................................................. 47 
 
List of Tables 
Table 1.  Minimum Data Elements ...................................................................................... 11 
Table 2.  Detailed Description of Administrative Tags* ........................................................ 12 
Table 3.   Detailed Description of Application Number Formats ............................................ 13 
Table 4.  Additional E2B Elements for Preferred MedDRA Coding...................................... 14 

Table 5.  Detailed Description of Drug(s) and Narrative Elements* ...................................... 15 
Table 6.  Receiver Information ............................................................................................ 17 
Table 7.  Combination Product Data Elements ..................................................................... 18 
Table 8.  Investigational New Drug Clinical Data Elements ................................................. 28 
Table 9.  Data Elements for IND-Exempt BA/BE Studies .................................................... 35 
Table 10.  Document Information Fields in ICSR Attachments............................................... 39 
Table 11.  Submission Rules and Acknowledgement Status ................................................... 40 
Table 12.  Examples of Application Number Formats and Drug Element Formats................... 41 
Table 13.  Case Scenario 1. For IND Safety Reports Submitted to FAERS ............................. 43 
Table 14.  Case Scenario 2. For IND Safety Reports Submitted to FAERS ............................. 45 
Table 15.  ICH E2B Data Element & Value Selections for IND-Exempt BA/BE Study 
Exposures............................................................................................................ 48 
Draft Version 1.9                      5  Specifications for Preparing and Submitting 
Electronic ICSRs and ICSR Attachments 
 
This document provides current specifications for submitting individual case safety reports 
(ICSRs) and ICSR attachments in electronic form.  The specifications apply to electronic 
submission of ICSRs for drug and biological products studied under an investigational new drug 
application (IND) (including bioequivalence studies conducted under IND), ICSRs from IND-
exempt bioavailability (BA)/bioequivalence (BE) studies, and ICSRs for marketed drug and 
biological products and combination products to the FDA Adverse Event Reporting System 
(FAERS).  The specifications do not apply to the following marketed biological products: 
prophylactic vaccines, whole blood or components of whole blood, human cells, tissues, and 
cellular and tissue-based products (HCT/Ps) regulated by FDA.  
This document discusses the technical specifications for electronic submission of ICSRs and 
ICSR attachments through the FDA Electronic Submissions Gateway (ESG).1   ICSRs (and any 
ICSR attachments) are to be prepared in accordance with the International Council for 
Harmonisation (ICH) E2B(R2) data elements in extensible markup language (XML) file format 
for compatibility with the FAERS database.  ICSRs for marketed products should not be 
submitted to the electronic Common Technical Document (eCTD).2   
If you have not previously submitted an ICSR in electronic format to FAERS, you should contact 
the FAERS electronic submission coordinator at faersesub@fda.hhs.gov and they will assist you 
with submission of a test file. 
I.  ELECTRONIC SUBMISSIONS OF ICSRS AND ICSR ATTACHMENTS 
Each initial ICSR or follow-up ICSR may consist of structured information and non-structured 
information, such as ICSR attachments.  
For the FDA to process, review, and archive the ICSRs, prepare your ICSRs for electronic 
submission by following these steps: 
  Provide a unique filename for the submission; see section II of this document. 
  Add a file header and file extension; see section IV of this document. 
  Populate the elements of the ICSR file; see section V of this document. 
 
1 For information on providing submissions using the ESG, refer to 
https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm. 
2 See FAERS Electronic Submissions at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm115894.htm. 
Draft Version 1.9                      6    If applicable, add ICSR attachments to ICSRs; see section VI of this document.  
II.  SUBMISSION FILE NAME 
Each electronic submission of ICSRs or attachments to ICSRs must have a unique filename (e.g., 
your named file + date and time stamp down to the second: filenameYYYYMMDDHHMMSS).  
You may choose your own format to maintain uniqueness. 
III.  ICSR ACKNOWLEDGEMENTS 
A. ESG Acknowledgement 
After submitting an ICSR or ICSR attachment, you should receive an ESG message delivery 
notice (MDN) notifying the sender of the receipt of their submission, but not acknowledging the 
acceptance of the submission.  If the MDN is not received within 2 hours, go to the ESG System 
Status web page.  If the ESG web page is non-operational, go to the ESG Home Page for further 
information. 
B.  FAERS Acknowledgment 
The MDN is then followed by a FAERS acknowledgment within 2 hours of the ESG 
acknowledgement.  The FAERS acknowledgement notifies the sender whether their submission 
has been processed.  If you do not receive the FAERS acknowledgement, resubmit the ICSRs 
without changing the filename. 
If you receive a report acknowledgement code 02, indicating that your submission did not 
process due to file error/s that are specified in the acknowledgment, then proceed as follows: 
  For submission with a single ICSR, resubmit the corrected ICSR with a new unique 
filename.  
  For a submission consisting of multiple ICSRs, if one or more ICSRs in the submission 
failed to process, separate those ICSRs from the processed ICSRs, correct them and 
resubmit only the corrected ICSRs as a new submission with a unique filename.  For 
example, if there were 50 ICSRs in an original submission and 15 of them failed to 
process, then only those 15 ICSRs must be separated, corrected appropriately, and 
resubmitted with a new unique filename.  The resubmission should not contain any of the 
previously processed ICSRs.  
IV.  ELECTRONIC TRANSPORT FORMAT:  XML FILES 
FDA accepts the data elements defined in the Guidance for Industry E2BM Data Elements for 
Draft Version 1.9                      7  Transmission of Individual Case Safety Reports (April 2002).3  The ICH E2B(R2) guidance 
provides additional information and clarification of the previously issued guidances.4 
The electronic transport format also known as the Document Type Definition (DTD) for XML 
files is described in the associated document XML Formatted DTD (DTD Version 2.1, DTD 
Version 2.2 and DTD Version 3.0) (see links to the documents below in section C). 
A. AS2 Headers and Routing IDs for Postmarketing Safety Report Submissions 
For postmarketing safety report submissions, the sponsors should include the unique AS2 
headers or routing IDs for safety reports and attachments in one of the two ways listed below.   
  AS2 Headers 
  Destination: CDER  
-
  XML files: AERS 
-
  PDFs: AERS_ATTACHMENTS 
-
or 
  Routing IDs   
  XML files: FDA_AERS 
-
  PDFs: FDA_AERS_ATTACHMENTS 
-
B.  AS2 Headers and Routing IDs for Premarketing5 Safety Report Submissions 
For premarketing safety report submissions, the sponsors should include the unique AS2 headers 
or routing IDs for premarketing safety reports and attachments, as listed below, to differentiate 
these reports between CDER and CBER, and from postmarketing ICSRs.   
 
 
3 For information on Guidance for Industry on E2BM Data Elements for Transmission of Individual Case Safety 
Reports, please refer to the following:  
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073092.pdf. 
4 See the guidance for industry entitled E2B Data Elements for Transmission of Individual Case Safety Reports 
(January 1998) (E2B). FDA currently supports use of E2B data elements in addition to the E2BM data elements. 
However, it is preferred that ICSRs be submitted with E2BM data elements to allow for the most efficient 
processing of the submissions. For those who wish to use E2B data elements and the corresponding electronic 
transport format (ICH M2 Electronic Transmission of Individual Case Safety Reports Message Specification Final 
Version 2.3 Document Revision February 1, 2001 (ICH ICSR DTD Version 2.1)), please refer to documentation 
provided at https://www.fda.gov/downloads/drugs/ucm149932.pdf 
5 The term premarketing safety report refers to IND safety reports and IND-exempt BA/BE studies safety reports. 
Draft Version 1.9                      8  1.  Submitting premarketing safety reports for CDER IND and IND-Exempt BA/BE 
  AS2 Headers   
  Destination: CDER  
-
  XML files: AERS_PREMKT_CDER  
-
  PDFs: AERS_ATTACHMENTS_PREMKT_CDER  
-
or 
  Routing IDs   
  XML files: FDA_AERS_PREMKT_CDER 
-
  PDFs: FDA_AERS_ATTACHMENTS_PREMKT_CDER 
-
 
2.  Submitting premarketing safety reports for CBER IND 
  AS2 Headers   
  Destination: CBER  
-
  XML files: AERS_PREMKT_CBER  
-
  PDFs: AERS_ATTACHMENTS_PREMKT_CBER  
-
or 
  Routing IDs   
  XML files: FDA_AERS_PREMKT_CBER 
-
  PDFs: FDA_AERS_ATTACHMENTS_PREMKT_CBER 
-
C. XML Header  
The addition of an XML header enables FDA to process ICSRs in an XML format successfully.  
FDA supports only the ISO-8859-1 character set for encoding the submissions.  
1.  For submissions of postmarketing safety reports for drug and biological products, 
add the following XML header to the ICSR file: 
<?xml version=1.0 encoding=ISO-8859-1?> 
<!DOCTYPE ichicsr SYSTEM https://www.accessdata.fda.gov/xml/icsr-xml-
v2.1.dtd> 
2.  For submissions of postmarketing safety reports for combination products, add the 
following XML header to the ICSR file: 
<?xml version=1.0" encoding=ISO-8859-1?> 
<!DOCTYPE ichicsr SYSTEM https://www.accessdata.fda.gov/xml/icsr-xml-
Draft Version 1.9                      9  v2.2.dtd> 
3.  For submissions of premarketing safety reports, add the following XML header to 
the ICSR file: 
<?xml version=1.0" encoding=ISO-8859-1?> 
<!DOCTYPE ichicsr SYSTEM https://www.accessdata.fda.gov/xml/icsr-xml-
v3.0.dtd> 
D. ICSR Message Header Information 
1.  For submissions of postmarketing drug and biological product safety reports, use 
the value 2.1 for the DTD Descriptor <messageformatversion>: 
<messageformatversion>2.1</messageformatversion> 
2.  For submissions of postmarketing combination product safety reports, use the 
value 2.2 for the DTD Descriptor <messageformatversion>: 
  <messageformatversion>2.2</messageformatversion> 
3.  For submissions of premarketing safety reports, use the value 3.0 for the DTD 
Descriptor <messageformatversion>: 
    <messageformatversion>3.0</messageformatversion> 
E.  ICSR File Extension 
Use xml as the file extension for ICSRs in XML format.  The name of the file should be 200 
characters or less, excluding the three-digit extension.  FDA does not support file names with 
multiple periods . or the use of any special or foreign characters except underscore _ and 
dash -. 
V.  DATA ELEMENTS FOR ELECTRONIC SUBMISSIONS 
A.  Minimum Data Elements Requirements 
For a submission to be successfully processed, submit an ICSR with the minimum data elements 
for reporting that are appropriate for the product type.  If a sponsor submits an ICSR without the 
minimum data elements, they will receive a FAERS acknowledgement code 02 stating that the 
submission was not processed (see section III.B above).  The minimum data elements for 
reporting are provided in Table 1 and the bullets that follow list the data elements to include in 
an ICSR by product type.  
 
 
Draft Version 1.9                      10  Table 1.  Minimum Data Elements 
Element  Data 
B.1  Identifiable Patient 
A.2  Identifiable Reporter 
B.2  Reaction or Event 
B.4  Suspect Drug Product 
  Adverse event reports submitted for unapproved prescription drug products, unapproved 
nonprescription drug products and products approved for marketing under an abbreviated 
new drug application (ANDA), biologics license application (BLA), or new drug 
application (NDA), including combination products should have, at a minimum, the four 
data elements listed in Table 1.   
  Adverse event reports for compounded drugs submitted by registered outsourcing 
facilities should have at a minimum, a suspect product and an adverse event. 
  IND safety reports should include, at a minimum, the four data elements listed in Table 1 
and the IND number under which the clinical trial where the event occurred is conducted. 
  Serious adverse event reports from IND-exempt BA/BE studies should include, at a 
minimum, the four data elements listed in Table 1 and the pre-assigned ANDA number 
(hereafter referred as, Pre-ANDA number). 
B.  Administrative and Identification Elements 
For FDA to successfully process your electronic ICSR submissions, populate the administrative 
and identification elements as indicated in Table 2. 
 
 
 
 
 
 
 
 
Draft Version 1.9                      11  Table 2.  Detailed Description of Administrative Tags* 
Element  DTD Descriptor 2.1  Length  Element Values for DTD 2.1 
A.1.9  <fulfillexpeditecriteria>  1N  1= Yes (15-Day expedited) 
2= No (non-expedited)  
4= 5-Day  
5= 30-Day  
6= 7-Day expedited 
A.1.0.1  <safetyreportid>  100AN  Senders (Case) Safety 
Report Unique Identifier 
A.1.10.1  <authoritynumb>  100AN  Regulatory authoritys case report 
number 
A.1.10.2  <companynumb>  100AN  Other senders case report number 
A.3.1.2  <senderorganization>  60AN  Sender identifier 
A.2.3.2^  <sponsorstudynumb>  35AN  IND or Pre-ANDA number under 
which the clinical trial where the event 
occurred is conducted 
A.1.FDA.16  <fdasafetyreporttype>  1N  1=IND Safety Report 
2=IND-Exempt BA/BE Safety Report 
3=Postmarketing Safety Report 
* Include either <companynumb> or <authoritynumb> values.  FDA cannot process the ICSR without one of these 
element values. 
 The Senders Safety Report Unique Identifier is comparable to the Manufacturer 
Report Number (also referred to as the Manufacturer Control Number (MCN)) provided on paper in FDA Form 
3500A.  This number is the companys unique case identification number, which is used for the life of the case. 
^ For IND and IND-exempt BA/BE study safety reports only.  An IND-exempt BA/BE study refers to a BA/BE 
study not conducted under IND. 
 The FDA Safety Report Type data element distinguishes premarketing (IND and IND-Exempt BA/BE) safety 
reports from postmarketing safety reports and is used to determine which reports are posted publicly. The FDA 
Safety Report Type data element is optional when using DTD 2.1 and 2.2 for postmarketing safety report submission 
but is mandatory when using DTD 3.0 for premarketing safety report submission.
  
C. Authorization/ Application Number Format 
In the section designated for drug and biological products information, use the following format 
for the Authorization/ Application Number element (B.4.k.4.1) <drugauthorizationnumb> as 
indicated in Table 3 and described below. 
  For approved drug and biological products marketed under an approved application, 
include the acronym NDA or ANDA, followed by a space and then the number for 
the application (e.g., NDA 012345, ANDA 012345).  For prescription drug products 
marketed without an approved application (Rx No Application), use 000000.  For a 
nonprescription drug product marketed without an approved application (Non-Rx No 
Draft Version 1.9                      12  Application), use 999999.  For adverse event reports for compounded drug products 
submitted by registered outsourcing facilities, use COMP99. 
  For marketed biological products, include the appropriate acronym BLA, STN, or 
PLA followed by a space and the primary six-digit number (e.g., STN 123456). 
Table 3.   Detailed Description of Application Number Formats 
Type of Application  Recommended Format 
NDA/ ANDA  NDA, ANDA 012345 
STN/ BLA/ PLA  STN or BLA or PLA 123456 
Rx No Application  000000 
Non-Rx No Application  999999 
Compounded Products  COMP99 
D. Unique Case Identification Numbers for Initial and Follow-Up ICSRs 
For the follow-up ICSR safety reports to be correctly linked to your initial ICSR report, follow 
these steps: 
  Use the same <safetyreportid> for the E2BM elements in section A.1.0.1 for the initial 
ICSR and any of its follow-up ICSRs; this allows the follow-up report to be linked to the 
initial report in the FAERS database. 
  If the initial ICSR was submitted on paper but its follow-up ICSR is submitted 
electronically, include the Manufacturer Control Number (MCN) listed in Box G9 of the 
FDA paper Form 3500A from the initial report in both A.1.0.1 <safetyreportid> and in 
A.1.10.2 <companynumb> field in the follow-up electronic submission. 
  Always use the <safetyreportid> that was assigned to the initial ICSR when submitting 
follow-up reports.  If you need to change the <safetyreportid> internally, note the 
internally reassigned <safetyreportid> in the narrative section of the follow-up report 
(i.e., element B.5.1) (e.g., This ICSR has been reassigned to the Company ID number 
COA12345).  Do not use the internally reassigned <safetyreportid> for any follow-up 
reports. 
  In the event that an incorrect <safetyreportid> has been used in a follow-up report, 
contact the FAERS electronic submission coordinator at  faersesub@fda.hhs.gov so that 
the follow-up ICSR can be matched to the initial ICSR.  
E.  MedDRA Specific Elements 
Use the ICH Medical Dictionary for Regulatory Activities (MedDRA) to code medical 
Draft Version 1.9                      13  terminology.6  When possible, use the Lowest Level Term (LLT), and record the LLT as the 
MedDRA numeric code rather than the LLT name (e.g., the LLT name is Rash; the MedDRA 
numeric code for LLT Rash is 10378444). 
1.  Reaction/Event 
a)  Reaction/Event as reported by the primary source field 
Record the original reporters words verbatim and/or use short phrases to describe the 
reaction/event in element (B.2.i.0). 
b)  Reaction/Event MedDRA Term LLT numeric code or text field 
Record the MedDRA LLT that most closely corresponds to the term reported by the 
original reporter in element (B.2.i.1). 
c)  Reaction/Event MedDRA Preferred Term (PT) numeric code or text field 
Record the MedDRA PT that most closely corresponds to the term reported by the 
original reporter in element (B.2.i.2). 
2.  Other E2B Elements 
For the E2B elements listed in Table 4, use either MedDRA text or, preferably, the 
corresponding numeric code. 
Table 4.  Additional E2B Elements for Preferred MedDRA Coding 
Element  DTD Descriptor 2.1  Length 
B.1.7.1a.2  <patientepisodename>  250 AN 
B.1.8f.2  <patientdrugindication>  250 AN 
B.1.8g.2  <patientdrugreaction>  250 AN 
B.1.9.2b  <patientdeathreport>  250 AN 
B.1.9.4b  <patientdetermineautopsy>  250 AN 
B.1.10.7.1a.2  <parentmedicalepisodename>  250 AN 
B.1.10.8f.2  <parentdrugindication>  250 AN 
B.1.10.8g.2  <parentdrugreaction>  250 AN 
B.3.1c  <testname>  100 AN 
B.4.k.11b  <drugindication>  250 AN 
B.4.k.17.2b  <drugrecuraction>  250 AN 
B.4.k.18.1b  <drugreactionasses>  250 AN 
B.5.3b  <senderdiagnosis>  250 AN 
 
6 Companies can license MedDRA from an international maintenance and support services organization (MSSO) 
(toll free number 877-258-8280; Direct 571-313-2574; fax 571-313-2345; e-mail MSSOhelp@mssotools.com). 
Draft Version 1.9                      14  F.  Drug Description and Case Narrative Elements 
To ensure the successful processing of your electronic ICSR submission, applicants are advised 
to populate the drug description and narrative elements as indicated in Table 5. 

Table 5.  Detailed Description of Drug(s) and Narrative Elements*  
Element  DTD Descriptor 2.1  Length  Element Values for DTD 2.1 
B.4.k.1  <drugcharacterization>  1N  1=Suspect 
2=Concomitant 
3=Interacting 
4=Drug not administered 
 
B.4.k.2.1  <medicinalproduct>  70AN  Proprietary Medicinal Product Name 
B.4.k.2.2  <activesubstancename>  100AN  Drug Substance Name 
B.5.1  <narrativeincludeclinical>  20000AN  Case Narrative 
*Include <medicinalproduct> and/or <activesubstancename>.  FDA cannot process the ICSR without at  
least one of these elements. 
Appendix I lists various examples of correct drug element formats. 
 
1.  Recording Multiple Drugs 
If you are submitting safety reports for products containing multiple drugs, you should follow 
these steps: 
  List the proprietary drug product name in element (B.4.k.2.1) and/or list the drug 
substance name in element (B.4.k.2.2). 
  List the characterization of each reported drugs role, such as suspect, concomitant, 
interacting, drug not administered, or similar device in element (B.4.k.1). 
2.  Medicinal Product Name and Active Drug Substance Name 
FDA validates medicinal product names to the available Structured Product Labeling (SPL)7, the 
submitted label (as ICSR attachment), and the Substance Registration System (SRS). These are 
further described below: 
  When the product has an SPL, use the same naming convention as it appears in the SPL 
when submitting the ICSR. 
 
7 The SPL is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a 
mechanism for exchanging product and facility information. See 
https://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. 
Draft Version 1.9                      15    When submitting a product label as an attachment to an ICSR, use the name as it appears 
on the submitted product label. 
  If no medicinal product is named and only the active substance is named, use the name of 
the active substance as it appears in the SRS.8 
3.  Case Narrative  
a)  Initial ICSR  
Record all case narrative information including clinical course, therapeutic measures, 
outcome, and all additional relevant information in element (B.5.1).  If the information 
exceeds the field length, consider describing the information using fewer words.  
Although the use of only the most widely used medical abbreviations is permissible if 
necessary, their use should be limited when possible.   
b)  Follow-up ICSR  
Record both new information and corrections to previously submitted ICSRs in element 
(B.5.1). 
G. Other Data Elements 
1.  Dosage Information Field 
If dosage information cannot be captured in the structured fields in B.4.k.5, then use the element 
(B.4.k.6) <drugdosagetext>. 
2.  Pharmaceutical Form Field 
Record the pharmaceutical form in element (B.4.k.7) <drugdosageform>.  FDA accepts the 
European Medicines Agency (EMA) dosage codes or text.9 
3.  Route of Administration Field 
Code the route of administration in element (B.4.k.8) <drugadministrationroute> as described in 
the ICH E2B(R2) guidance. 
4.  Receiver Field (A.3.2) 
Complete the receiver using the code or text listed in Table 6.  
 
8 https://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-
UniqueIngredientIdentifierUNII/default.htm. 
9 For a complete list of EMA dosage form codes and text, please refer to 
https://www.ema.europa.eu/documents/other/list-pharmaceutical-dosage-forms_en.xls   
Draft Version 1.9                      16  Table 6.  Receiver Information 
Element  DTD Descriptor 2.1  Code or Text 
A.3.2.1  <receivertype>  2 
A.3.2.2a  <receiverorganization>  FDA 
A.3.2.2b  <receiverdepartment>  Office of Surveillance and Epidemiology 
A.3.2.2d  <receivergivename>  FAERS 
A.3.2.3a  <receiverstreetaddress>  10903 New Hampshire Avenue 
A.3.2.3b  <receivercity>  Silver Spring 
A.3.2.3c  <receiverstate>  MD 
A.3.2.3d  <receiverpostcode>  20993 
A.3.2.3e  <receivercountrycode>  US 
A.3.2.3l  <receiveremailaddress>  faersesub@fda.hhs.gov 
 
5.  Message Receiver Field (M.1.6) 
The following two message receiver identifiers are used by FDA to distinguish between test and 
production submissions:  
  Test ICSRs:  <messagereceiveridentifier>ZZFDATST</messagereceiveridentifier> 
  Production ICSRs:  <messagereceiveridentifier>ZZFDA</messagereceiveridentifier> 
H. Data Elements for Electronic Submissions of Safety Reports for Postmarketing 
Combination Products  
To ensure the successful processing of your electronic ICSR submission for a marketed drug- or 
therapeutic biologic led- combination product (e.g., a combination product containing a 
drug/biologic and device and marketed under an NDA or a BLA), you should populate the data 
elements indicated in Table 7. 
Note: Some of the DTD descriptors listed in Table 7 are under existing E2B(R2) header 
elements, and some DTD descriptors are under new data elements.  Those data element numbers 
that are new, have the word FDA incorporated into the number and are U.S.-specific regional 
elements related to reporting on combination products. 
Draft Version 1.9                      17   
Table 7.  Combination Product Data Elements 
Element Values 
Data Element  DTD Descriptor 2.2  Title  Description  Length  Notes 
for DTD 2.2 
M.1.2  <messageformatversion>  Message  Version number  3AN  2.2  Use value 2.2 if using icsr-
Format  of Message  xml-v2.2.dtd 
Version  Format   
Use value 2.1 if using icsr-
xml-v2.1.dtd 
A.1  <safetyreport>  Header/  Identification of          
Entity  the case safety 
report 
A.1.9  <fulfillexpeditecriteria>  Does this     1N  1=Yes  Element values= 1 for 15-Day 
case fulfill  2=No  Expedited* and 2 for periodic 
the local  4=5-Day  non-expedited 
criteria for an  5=30-Day   
expedited  Element value= 4 for remedial 
report  action to prevent an 
unreasonable risk of 
substantial harm to the public 
health 
 
Element value= 5 for 
malfunction with no associated 
adverse event 
 
Do not use element value of 3. 
 
A.1.FDA.15  <combinationproductreport>  Combination  Combination  1N  1=Yes 
Product  Product Report  2=No 
Report Flag  Flag 
A.2  <primarysource>  Primary  Header/ Entity     Area below    
source(s) of  should be a 
information  repeatable block 
Draft Version 1.9                      18   
Element Values 
Data Element  DTD Descriptor 2.2  Title  Description  Length  Notes 
for DTD 2.2 
A.2.1     Primary  Header          
source(s) 
A.2.1.3.FDA.4  <reporteremailaddress>  Reporters     100AN       
Email 
Address 
B.1.1  <patientinitial>  Patient  Patient Identifier  10AN     If a single report is reported 
for a malfunction with no 
adverse event, the element 
value should be NONE. 
 
If there are multiple 
malfunction reports with no 
adverse event, then the 
element value should be 
SUMMARY. 
B.4  <drug>  Drug(s)  Header/ Entity     Area below    
Information  should be a 
repeatable block 
B.4.k.1  <drugcharacterization>  Characterizat   1N  1=Suspect  If the product in the report is 
ion of drug  2=Concomitant  about a similar device, the 
3=Interacting 
role  element value should be 
5=Similar 
5=Similar Device. 
Device 
B.4.k.2     Drug  Header          
Identification 
B.4.k.2.4.FDA.1a  <expirationdateformat>  Expiration  Product  3N  102=CCYYMM   
date format  Expiration date  DD 
610=CCYYMM 
602=CCYY 
B.4.k.2.4.FDA.1b  <expirationdate>  Expiration  Product  8N       
date  Expiration date 
Draft Version 1.9                      19   
Element Values 
Data Element  DTD Descriptor 2.2  Title  Description  Length  Notes 
for DTD 2.2 
B.4.k.2.FDA.5  <productavailableforevaluation>  Product  Indicate whether  1N  1=Yes    
available for  product is  2=No 
evaluation  available for  3=Return 
evaluation 
B.4.k.2.6.FDA.1a  <productreturndateformat>  Product  Date Format  3N  102=CCYYMM   
return date  DD 
format  610=CCYYMM 
602=CCYY 
B.4.k.2.6.FDA.1b  <productreturndate>  Product  Date when  8N       
return date  Product was 
returned 
B.4.k.20.FDA.1  <brandname>  Brand Name  The trade or  80AN     At least one of the 3 must be 
proprietary name  reported <brandname> or 
of the device  <commondevicename> or 
constituent part  <productcode> for the device 
of the suspect  constituent part 
combination 
product as used 
in product 
labeling or in the 
catalog 
B.4.k.20.FDA.2  <commondevicename>  Common  Generic or  80AN     At least one of the 3 must be 
Device Name  common name of  reported <brandname> or 
the device  <commondevicename> or 
constituent part  <productcode> for device 
of the suspect  constituent part 
combination 
product or a 
generally 
descriptive name 
B.4.k.20.FDA.3  <productcode>  Product Code  Product code  3AN  http://www.acce At least one of the 3 must be 
Draft Version 1.9                      20   
Element Values 
Data Element  DTD Descriptor 2.2  Title  Description  Length  Notes 
for DTD 2.2 
assigned to the  ssdata.fda.gov/p reported <brandname> or 
device  remarket/ftparea <commondevicename> or 
constituent part  /foiclass.zip   <productcode> for device 
based upon the  constituent part 
medical device 
product 
classification 
 
B.4.k.20.FDA.4  <manufacturer>  Manufacturer  Header/ Entity       
B.4.k.20.FDA.4a  <manufacturername>  Device  Manufacturer  100AN       
Manufacturer  name of the 
Name  device 
constituent part 
of the suspect 
combination 
product 
B.4.k.20.FDA.4b  <manufactureraddress>  Manufacturer  Manufacturer  100AN       
Address  address of the 
device 
constituent part 
of the suspect 
combination 
product 
B.4.k.20.FDA.4c  <manufacturercity>  Manufacturer  Manufacturer  35AN       
City  city of the device 
constituent part 
of the suspect 
combination 
product 
B.4.k.20.FDA.4d  <manufacturerstate>  Manufacturer  Manufacturer  40AN       
State  state of the 
device 
Draft Version 1.9                      21   
Element Values 
Data Element  DTD Descriptor 2.2  Title  Description  Length  Notes 
for DTD 2.2 
constituent part 
of the suspect 
combination 
product 
B.4.k.20.FDA.4e  <manufacturercountry>  Manufacturer  Manufacturer  2AN  ISO3166    
Country  country of the 
device 
constituent part 
of the suspect 
combination 
product 
B.4.k.20.FDA.5  <modelnumber>  Model  Model number of  30AN       
Number  the device 
constituent part 
B.4.k.20.FDA.6  <catalognumber>  Catalog  Catalog number  30AN       
Number  of the device 
constituent part 
B.4.k.20.FDA.7  <serialnumber>  Serial  Serial number of  30AN       
Number  the device 
constituent part 
B.4.k.20.FDA.8  <udinumber>  Unique  Unique identifier  50AN       
Identifier  of the device 
UDI#  constituent part 
B.4.k.20.FDA.9a  <dateimplantedformat>  Device  Date format of  3N  102=CCYYMM For medical devices that are 
Implant Date  device implant in  DD  implanted in the patient, 
Format  the patient  610=CCYYMM  provide the implant date or 
602=CCYY  best estimate. If day is 
unknown, month and year are 
acceptable. If month and day 
are unknown, year is 
acceptable 
Draft Version 1.9                      22   
Element Values 
Data Element  DTD Descriptor 2.2  Title  Description  Length  Notes 
for DTD 2.2 
B.4.k.20.FDA.9b  <dateimplanted>  Device  Date of device  8N     For medical devices that are 
Implant Date  implant in the  implanted in the patient, 
patient  provide the implant date or 
best estimate. If day is 
unknown, month and year are 
acceptable. If month and day 
are unknown, year is 
acceptable 
B.4.k.20.FDA.10a  <dateexplantedformat>  Device  Date format of  3N  102=CCYYMM If an implanted device was 
Explant Date  device explant  DD  removed from the patient, 
Format  from the patient  610=CCYYMM  provide the explant date or 
602=CCYY  best estimate. If day is 
unknown, month and year are 
acceptable. If month and day 
are unknown, year is 
acceptable 
B.4.k.20.FDA.10b  <dateexplanted>  Device  Date of device  8N     If an implanted device was 
Explant Date  explant from the  removed from the patient, 
patient  provide the explant date or 
best estimate. If day is 
unknown, month and year are 
acceptable. If month and day 
are unknown, year is 
acceptable 
B.4.k.20.FDA.11a  <deviceage>  Approximate  Age of device  5N       
age of  constituent part 
device/ 
product 
B.4.k.20.FDA.11b  <deviceageunit>  Approximate  Age unit of  3N  800=Decade    
age unit of  device  801=Year 
device/  constituent part  802=Month 
Draft Version 1.9                      23   
Element Values 
Data Element  DTD Descriptor 2.2  Title  Description  Length  Notes 
for DTD 2.2 
product  803=Week 
804=Day 
805=Hour 
B.4.k.20.FDA.12  <labeledsingleusedevice>  Single Use  Indicate whether  1N  1=Yes    
Device  the device  2=No 
constituent part 
was labeled for 
single use or not 
B.4.k.20.FDA.13a  <devicemanufacturedateformat>  Device  Device  3N  102=CCYYMM   
Manufacture  Manufacture  DD 
Date Format  Date format  610=CCYYMM 
602=CCYY 
B.4.k.20.FDA.13b  <devicemanufacturedate>  Device  Device  8N       
Manufacture  Manufacture 
Date  Date 
B.4.k.20.FDA.14     Remedial  Header          
action 
initiated/ 
Remedial 
action taken 
for the 
product 
B.4.k.20.FDA.14.1 <remedialactionrecall>  Recall  Recall initiated  1N  1=Yes    
a  2=No 
B.4.k.20.FDA.14.1 <remedialactionrepair>  Repair  Repair initiated  1N  1=Yes    
b  2=No 
B.4.k.20.FDA.14.1 <remedialactionreplace>  Replace  Replace initiated  1N  1=Yes    
c  2=No 
B.4.k.20.FDA.14.1 <remedialactionrelabel>  Relabeling  Relabeling  1N  1=Yes    
d  initiated  2=No 
B.4.k.20.FDA.14.1 <remedialactionnotify>  Notification  Notification  1N  1=Yes    
Draft Version 1.9                      24   
Element Values 
Data Element  DTD Descriptor 2.2  Title  Description  Length  Notes 
for DTD 2.2 
e  initiated  2=No 
B.4.k.20.FDA.14.1 <remedialactioninspection>  Inspection  Inspection  1N  1=Yes    
f  initiated  2=No 
B.4.k.20.FDA.14.1 <remedialactionpatientmonitor>  Patient  Patient  1N  1=Yes    
g  monitoring  monitoring  2=No 
B.4.k.20.FDA.14.1 <remedialactionmodifyadjust>  Modification/ Modification/  1N  1=Yes    
h  Adjustment  Adjustment  2=No 
initiated 
B.4.k.20.FDA.14.1i  <remedialactionother>  Other  Other Remedial  75AN       
Action initiated 
B.4.k.20.FDA.15  <deviceusage>  Device  Indicate the use  1N  1=Initial Use of    
Usage  of the device  Device 
constituent part  2=Reuse  
of the suspect  3=Unknown 
combination 
product 
B.4.k.20.FDA.16  <devicelotnumber>  Device Lot  Lot number of  35AN       
Number  the device 
constituent part 
of the suspect 
combination 
product 
B.4.k.20.FDA.17  <malfunction>  Malfunction  Malfunction of  1N  1=Yes    
product  2=No 
 
B.4.k.20.FDA.18  Follow-up  Header          
type 
B.4.k.20.FDA.18.1 <followupcorrection>  Correction  Correction  1N  1=Yes    
a  2=No 
B.4.k.20.FDA.18.1 <followupadditionalinfo>  Additional  Additional  1N  1=Yes    
b  information  information  2=No 
B.4.k.20.FDA.18.1 <followupresponsetoFDA>  Response to  Response to FDA  1N  1=Yes    
Draft Version 1.9                      25   
Element Values 
Data Element  DTD Descriptor 2.2  Title  Description  Length  Notes 
for DTD 2.2 
c  FDA request  request  2=No 
B.4.k.20.FDA.18.1 <followupdeviceevaluation>  Device  Device  1N  1=Yes    
d  Evaluation  Evaluation  2=No 
B.4.k.20.FDA.19  <deviceproblemandevaluation>  Device  Header/ Entity     Area Below    
Problem and  Should be a 
evaluation  Repeatable 
codes  Block 
B.4.k.20.FDA.19.1 <evaluationtype>  Evaluation  Type of problem  2N  01=Device    
a  Type  and/or the  Problem 
evaluation  02=Method 
03=Result 
04=Conclusion 
B.4.k.20.FDA.19.1 <evaluationvalue>  Evaluation  The FDA code  6N     The value depends on the 
b  Value  value based on  respective <evaluationtype> 
the respective    
evaluation type   If <evaluationtype> = 01 --> 
https://www.fda.gov/media/14
6825/download  
 
If <evaluationtype> = 02 --> 
https://www.fda.gov/media/14
6827/download  
 
If <evaluationtype> = 03 --> 
https://www.fda.gov/media/14
6828/download 
 
If <evaluationtype> = 04 --> 
https://www.fda.gov/media/14
6829/download  
B.4.k.20.FDA.20  <operatorofdevice>  Operator of  Operator of the  100AN     Use the value Health 
Draft Version 1.9                      26   
Element Values 
Data Element  DTD Descriptor 2.2  Title  Description  Length  Notes 
for DTD 2.2 
the Device  Device  Professional or Lay 
User/Patient. If none 
applicable, then specify the 
Other value 
* 21 CFR 314.80(c)(1) and 600.80(c)(1) use the term 15-day Alert reports. In the combination product PMSR final rule (21 CFR 4.101), these reports are defined as 
Fifteen-day reports. 
 Periodic non-expedited ICSRs are the reports required under 21 CFR 314.80(c)(2)(ii)(B) and 21 CFR 600.80(c)(2)(ii)(B) for serious, expected and nonserious adverse 
drug experiences. 
 
 
Draft Version 1.9                      27   
I.  Data Elements for Electronic Submissions of IND Safety Reports 
To ensure the successful processing of your electronic IND ICSR submission, you should populate the following data elements as 
described in Table 8. 
Table 8.  Investigational New Drug Clinical Data Elements 
Data  Field  Element Values for 
DTD Descriptor 3.0  Title  Description  Notes 
Element  Length  DTD 3.0 
A.1.4  <reporttype>  Type of    1N  1=Spontaneous  Element value= 2 for 
Report  2=Report from  Report from Study 
Study 
3=Other 
4=Not Available to 
Sender (unknown) 
A.1.9  <fulfillexpeditecriteria>  Does this    1N  1=Yes   Element value=1 for 15-
case fulfill  2=No   Day Expedited  
4=5-Day    
the local 
5=30-Day  Element value= 6 for 7-
criteria for an 
6=7-Day   Day Expedited  
expedited 
report? 
A.1.12  <linkreportnumb>  Identification    100AN    Used to link all 
Number of  individual cases 
the report  (safetyreportid) that make 
which is  up an IND Safety Report 
linked to this  submitted as a result of 
report  an Aggregate Analysis as 
per 312.32(c)(1)(i)(C) or 
for several events 
Draft Version 1.9                      28   
Data  Field  Element Values for 
DTD Descriptor 3.0  Title  Description  Notes 
Element  Length  DTD 3.0 
submitted as per 
(312.32(c)(1)(i)(B)) when 
a Narrative Summary 
Report is provided, this 
field should be populated 
in the IND Safety Report 
that contains the 
Narrative Summary 
Report. 
A.2.3.1  <studyname>  Study Name    100AN  Study  The Study ID should be 
ID_$Abbreviated  the same value used in 
the study tagging file 
Trial Name 
format of the eCTD 
submission. 
A.2.3.2  <sponsorstudynumb>  Sponsor    35AN  IND number under  Populate this field with 
Study  which the clinical  the Primary IND in the 
Number  trial where the event  first block and repeat 
occurred is  block A.2 with elements 
conducted  A.2.3.2 and A.2.3.3.as 
  noted below with element 
Use the Parent  value= 5 for sponsors 
IND number* for  other INDs evaluating 
reports submitted  suspect product (where 
from an Aggregate  applicable) 
Analysis as per  Include the acronym 
(312.32(c)(1)(i)(C))  "IND" followed by a 
or for several events  space and then the IND 
Draft Version 1.9                      29   
Data  Field  Element Values for 
DTD Descriptor 3.0  Title  Description  Notes 
Element  Length  DTD 3.0 
submitted as per  number for the 
(312.32(c)(1)(i)(B)),  application (e.g. IND 
from trials  123456) 
conducted under  See Appendix II (Case 
more than one IND   Scenarios) for additional 
information on how to 
submit reports from 
sponsors other INDs 
(Cross-reporting). 
A.2.3.3  <observestudytype>  Study type in    1N  1= Clinical Trials  Required if element value 
which the    for A.1.4 is 2=Report 
Reaction(s)/  2= Individual Patient  from Study 
Event(s)  Use (e.g.,   
were  Compassionate  Repeat this field as 
observed  Use or Named  needed with element 
Patient Basis)  value= 5 for each Cross-
  reported IND.  
3= Other Studies   
(e.g.,  The first block of this 
Pharmacoepidemiolo element in the report 
gy,  must not be 5. 
Pharmacoeconomics,   
Intensive  If element value 4 is 
Monitoring)  chosen, then A.1.9= 1. 
   
4= Report from  See Appendix II (Case 
Draft Version 1.9                      30   
Data  Field  Element Values for 
DTD Descriptor 3.0  Title  Description  Notes 
Element  Length  DTD 3.0 
Aggregate Analysis  Scenarios) for additional 
as per  information on how to 
312.32(c)(1)(i)(C) or  submit reports from an 
for several events  Aggregate Analysis. 
submitted as per 
312.32(c)(1)(i)(B) if 
a Narrative 
Summary Report is 
provided 
 
5= Cross-reported 
IND Safety Report 
B.1.1  <patientinitial>  Patient    10AN    For a report from an 
Identifier  Aggregate Analysis as 
per 312.32(c)(1)(i)(C) or 
for several events 
submitted as per 
312.32(c)(1)(i)(B) if a 
Narrative Summary 
Report is provided, the 
element value should be 
AGGREGATE 
B.4.k.2.1  <medicinalproduct>  Proprietary    70AN    For investigational drug 
Medicinal  and biological products 
Product  without an established 
Name  name (i.e. INN or USAN 
Draft Version 1.9                      31   
Data  Field  Element Values for 
DTD Descriptor 3.0  Title  Description  Notes 
Element  Length  DTD 3.0 
name), prior to 
submitting IND safety 
reports to FAERS, the 
sponsor should submit a 
clinical information 
amendment to the IND, 
listing the names of the 
active drug substance/s 
and the medicinal product 
as they will be reported in 
E2B file submissions.  
The names should fit 
within the established 
E2B character length 
limits. 
Use company product 
code if no established 
name, for multi-
ingredient products, or if 
name exceeds character 
length 
B.4.k.2.2  <activesubstancename>  Active Drug    100AN      
Substance 
Names 
B.4.k.18  <drugreactionrelatedness>  Relatedness        For IND Safety Reports, 
of Drug to  at least one suspect 
Draft Version 1.9                      32   
Data  Field  Element Values for 
DTD Descriptor 3.0  Title  Description  Notes 
Element  Length  DTD 3.0 
Reaction/  product should have 
Event  relatedness of drug to 
reaction/ event 
B.4.k.18.1a  <drugreactionassesmeddra MedDRA    8AN     
version>  Version for 
Reaction 
Assessed 
B.4.k.18.1b  <drugreactionasses>  Reaction    250AN     
Assessed 
B.4.k.18.2  <drugassessmentsource>  Source of    60AN    Use the value Sponsor or 
Assessment  Investigator. Include 
sponsor and investigator 
assessment when 
reporting both in separate 
blocks  
B.4.k.18.3  <drugassessmentmethod>  Method of    35AN    Use the value FDA. 
Assessment 
B.4.k.18.4  <drugresult>  Result    35AN  1=Suspected  For IND Safety Reports, 
2=Not suspected  at least one suspect 
product should have 
relatedness of drug to 
reaction/ event 
B.5.1  <narrativeincludeclinical>  Case    20,000    FDA strongly encourages 
Narrative  AN  sponsors to construct 
Including  narratives that fit within 
Clinical  the ICH E2B character 
Draft Version 1.9                      33   
Data  Field  Element Values for 
DTD Descriptor 3.0  Title  Description  Notes 
Element  Length  DTD 3.0 
Course,  limit of 20,000 AN. If 
Therapeutic  your narrative exceeds 
Measures,  this limit, sponsors 
Outcome,  should include as much 
and  of the narrative as 
Additional  possible in this field and 
Relevant  submit an ICSR 
Information  attachment for any text 
that exceeds the character 
limit. Sponsors should 
not submit an ICSR 
attachment containing the 
entire narrative and leave 
the case narrative field 
empty. 
For reports from 
Aggregate Analysis as 
per 312.32(c)(1)(i)(C) or 
for several events 
submitted as per 
312.32(c)(1)(i)(B) where 
PDF is attached, put see 
attached Narrative 
Summary Report in this 
field.  
Draft Version 1.9                      34   
Data  Field  Element Values for 
DTD Descriptor 3.0  Title  Description  Notes 
Element  Length  DTD 3.0 
B.5.4  <sendercomment>  Senders    2000    Identification and 
Comments  AN  analysis of previously 
submitted events (as 
required by 312.32(c)(1)) 
should be reported in this 
field. 
* The parent IND is the IND under which clinical investigations were initiated in the United States. (If the drug is being evaluated in multiple INDs, this is 
generally the IND with the lowest number.)  NOTE: This may not be the same as the first A.2.3.2 block if the drug is being evaluated under multiple INDs. 
 
NOTE: See FAERS Webpage for case scenario examples for reporting IND safety reports (e.g., IND safety reports where the sponsor 
is evaluating suspect product under more than one IND, IND safety reports that are a result of an aggregate analysis, and IND safety 
reports with unapproved and approved drugs listed as suspect products). 
J.  Data Elements for Electronic Submissions of ICSRs from IND-Exempt Bioavailability (BA)/ Bioequivalence (BE) 
Studies  
For successful processing of your electronic ICSRs submissions for a BA/BE study not conducted under an IND, you should populate 
the following data elements as described in Table 9. 
Table 9.  Data Elements for IND-Exempt BA/BE Studies  
Data  Field  Element Values for DTD 
DTD Descriptor 3.0  Title  Description  Notes 
Element  Length  3.0 
A.1.4  <reporttype>  Type of Report    1N  1=Spontaneous  Element value= 2 
2=Report from Study  for Report from 
3=Other  Study 
4=Not Available to Sender 
(unknown) 
Draft Version 1.9                      35   
Data  Field  Element Values for DTD 
DTD Descriptor 3.0  Title  Description  Notes 
Element  Length  3.0 
A.1.9  <fulfillexpeditecriteria>  Does this Case    1N  1=Yes   Element value=1 
Fulfill the Local  2=No   for 15-Day 
Criteria for an  4=5-Day   Expedited  
Expedited  5=30-Day  Or 
Report?  6=7-Day   Element value= 6 
for 7-Day 
Expedited  
 
A.2.3.1  <studyname>  Study Name    100AN  Abbreviated Trial Name 
A.2.3.2  <sponsorstudynumb>  Sponsor Study    35AN  Pre-ANDA number for the  Include the 
Number  IND-Exempt BA/BE  acronym "Pre-
Studies  ANDA" followed 
by a space and then 
the Pre-ANDA 
number for the 
application (e.g. 
Pre-ANDA 123456) 
A.2.3.3  <observestudytype>  Study Type in    1N  1= Clinical Trials  Element value=1 
Which the    for Clinical Trials. 
Reaction(s)/  2= Individual Patient Use 
Event(s) were  (e.g., Compassionate Use 
Observed  or Named Patient Basis) 
 
3= Other Studies (e.g., 
Pharmacoepidemiology, 
Pharmacoeconomics, 
Intensive Monitoring) 
 
4= Report from Aggregate 
Analysis as per 
312.32(c)(1)(i)(C) or for 
Draft Version 1.9                      36   
Data  Field  Element Values for DTD 
DTD Descriptor 3.0  Title  Description  Notes 
Element  Length  3.0 
Several Events Submitted 
as per 312.32(c)(1)(i)(B) if 
a Narrative Summary 
Report is Provided 
 
5= Cross-Reported IND 
Safety Report 
B.4.k.2.1  <medicinalproduct>  Proprietary    70AN     
Medicinal 
Product Name 
B.4.k.1  <drugcharacterization>  Characterization    1N  1 = Suspect  For no exposure to a 
of drug role  2 = Concomitant  study drug use 
4=Drug not 
3 = Interacting 
administered 
4 = Drug not administered 
B.4.k.2.2  <activesubstancename>  Active Drug    100AN      
Substance Name 
B.4.k.19  <drugadditional>  Additional    100AN  1 = Test drug  Specify whether the 
Information on  2 = Reference drug  product exposed is 
Drug  3 = Placebo/Vehicle  the Test drug, 
4 = Control (negative or  Reference drug, 
positive)  Placebo, Vehicle, 
5 = Other drug  Control or Other 
drug 
 
   
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VI.  ELECTRONIC FORMAT FOR ICSR ATTACHMENTS 
FDA can accept and archive ICSR attachments in PDF format.  Currently approved formats for the non-
structured component of an ICSR, such as ICSR attachments, are PDF versions 1.4 (current ICH 
standard) or 1.6 (current version in use at FDA).  An ICSR attachment should be electronically 
submitted to FAERS after the associated ICSR has been submitted and accepted by  FAERS.   
A. Converting the ICSR Attachment to PDF 
Applicants should provide an individual PDF file for each ICSR attachment.  If you are submitting 
multiple ICSR attachments for a particular ICSR, include each attachment in the same PDF file and 
provide a PDF bookmark to distinguish each attachment.  For example, if you are submitting a hospital 
discharge summary and an autopsy report for a single ICSR, include both in a single PDF file with a 
bookmark to the hospital discharge summary and a bookmark to the autopsy report. 
B.  Identification Information in the PDF Document Information Fields 
Each PDF file contains fields to be completed by the author of the document.  FAERS uses these fields 
to locate and retrieve the attachments to specific ICSRs.  To enable FDA to match the attachment(s) to 
the correct ICSR, applicants should fill in the PDF document information fields with the appropriate 
E2B(R2) data elements for the ICSR as indicated in Table 10. 
 
   
Draft Version 1.9                      38   
Table 10.  Document Information Fields in ICSR Attachments 
PDF Document  Include/ 
Document Information*  Length 
Information Field  Optional 
Title  Include  A.1.0.1 <safetyreportid>  100AN 
Senders (Case) Safety Report Unique 
Identifier 
Subject  Include  A.1.10.1 <authoritynumb> Regulatory  100AN 
Authoritys Case Report Number 
OR 
A.1.10.2 <companynumb> 
Other Senders Case Report Number 
Author  Optional  A.1.11.2 <duplicatenumb> Other  100AN 
Identification Number 
Keywords  Optional  A.1.7b <receiptdate>  8N 
Date of Receipt of the Most Recent 
Information for this ICSR 
* The information refers to the data elements in E2B(R2) 
 
In addition: 
  Use the ISO-8859-1 character set for the information fields. 
  Do not exceed the character length indicated above for each information field. 
  Avoid creating any custom fields with names identical to the information fields listed in Table 
10. 
If you need assistance, you can contact the FAERS electronic submission coordinator at 
faersesub@fda.hhs.gov. 
VII.  SUBMISSION RULES 
The submission rules define the condition that shall result in a negative acknowledgement and not be 
accepted by FAERS. 
 
 
 
 
Draft Version 1.9                      39   
Table 111.  Submission Rules and Acknowledgement Status 
Data  DTD Descriptor  Rejection Rule Description  Acknowledgement 
Element  2.1/2.2/3.0 
NA  NA  ICSR submitted via AS2 Header  reportacknowledgmentcode 
where XML file: AERS   (B.1.8) = 02 
or  
Routing ID where XML file: 
FDA_AERS and using DTD 3.0  
NA  NA  ICSR submitted via AS2 Header  reportacknowledgmentcode 
where XML file:  (B.1.8) = 02 
AERS_PREMKT  
or  
Routing ID where XML file: 
FDA_AERS_PREMKT and using 
DTD 2.1 or 2.2 
A.1.FDA.16  <fdasafetyreporttype>  ICSR submitted via AS2 Header  reportacknowledgmentcode 
where XML file: AERS_PREMKT   (B.1.8) = 02 
or  
Routing ID where XML file: 
FDA_AERS_PREMKT using 
DTD 3.0 and data value is empty 
A.2.3.2  <sponsorstudynumb>  ICSR submitted via AS2 Header  reportacknowledgmentcode 
where XML file: AERS_PREMKT   (B.1.8) = 02 
or  
Routing ID where XML file: 
FDA_AERS_PREMKT using 
DTD 3.0 and data value is empty 
or not prefixed with IND or Pre-
ANDA 
Draft Version 1.9                      40   
APPENDIX I. EXAMPLES OF CORRECT AND INCORRECT APPLICATION NUMBER AND DRUG ELEMENT 
FORMATS 
Table 122.  Examples of Application Number Formats and Drug Element Formats 
Examples of Application Number Format  Comment 
Correct  <drugauthorizationnumb>NDA 012345</drugauthorizationnumb>   
Correct  <drugauthorizationnumb>BLA 123456</drugauthorizationnumb>   
Correct  <drugauthorizationnumb>NDA 012345</drugauthorizationnumb>   
<drugauthorizationholder>COMPANYX</drugauthorizationholder> 
Incorrect  <drugauthorizationnumb>123456/10300</drugauthorizationnumb>  Use the appropriate prefix for the 
NDA/ ANDA/ STN/ BLA/ PLA. Do not 
include additional data after the 
application number 
Incorrect  <drugauthorizationnumb>NDA 12-345;IND12,345 </drugauthorizationnumb>  Omit hyphens and commas in the 
application number. Do not populate the 
tag with two application numbers 
Incorrect  <drugauthorizationnumb>OTC Product</drugauthorizationnumb>  For a non-prescription drug product 
marketed without an approved application 
(Non-Rx No Application), use 999999" 
Incorrect  <drugauthorizationnumb>NDA  Do not populate the company name in the 
  012345(COMPANYX)</drugauthorizationnumb>  <drugauthorizationnumb> tag 
<drugauthorizationholder></drugauthorizationholder> 
 
 
Final Version 1.6          41 
   
   
Examples of Application Number Format  Comment 
Correct  <medicinalproduct>TYLENOL</medicinalproduct>   
<activesubstancename>ACETAMINOPHEN</activesubstancename> 
Correct  <medicinalproduct>MIRACLE WONDER DRUG</medicinalproduct>   
<activesubstancename>ACETAMINOPHEN</activesubstancename> 
Incorrect  <medicinalproduct>AMAZING DRUG OTC</medicinalproduct>   
<activesubstancename>ACETAMINOPHEN 500 mg</activesubstancename> 
Incorrect  <medicinalproduct>NEW DRUG 40 mcg/mL</medicinalproduct>   
<activesubstancename>NEWSUBSTANCE Inj </activesubstancename> 
Incorrect  <medicinalproduct>MWD</medicinalproduct>  Do not use abbreviations for the brand 
name or active substance in the 
<activesubstancename>APAP</activesubstancename> 
<medicinalproduct> and 
<activesubstance> 
tags 
 
   
Final Version 1.6          42 
   
APPENDIX II. CASE SCENARIOS FOR IND SAFETY REPORTS SUBMITTED TO 
FAERS 
The following case scenarios are intended to provide examples to sponsors on the use of ICH 
E2B data standard elements for submission of IND safety reports to FAERS that may differ from 
postmarketing safety reports.  
1.  For any IND safety report where the sponsor is evaluating the suspect product under more 
than one IND (i.e. Cross-reporting) 
a.  Repeat block A.2 for each IND 
i.  Use first block A.2 to designate IND where the event occurred = primary 
IND 
1.  A.2.3.2 = primary IND 
2.  A.2.3.3 = data value could either be 1, 2, 3, or 4 
3.  Other relevant information for the report to be populated in block A.2 
ii.  Repeat block A.2 as many times as needed with only the following data 
elements for each IND that the sponsor holds where that suspect product is 
being evaluated: 
1.  A.2.3.2 = IND number for each cross-reported IND  
and  
2.  A.2.3.3 = 5  
Table 133.  Case Scenario 1. For IND Safety Reports Submitted to FAERS 
Data 
DTD Descriptor 3.0  Title  Element Values for DTD 
Element 
A.2.3.2  <sponsorstudynumb>  Sponsor  IND number under which the Clinical 
Study  Trial where the event occurred is 
Number  conducted 
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Data 
DTD Descriptor 3.0  Title  Element Values for DTD 
Element 
A.2.3.3  <observestudytype>  Study Type in  1= Clinical Trial 
Which the   
Reaction(s)  2= Individual Patient Use (e.g. 
were  Compassionate Use or Named 
observed  Patient Basis) 
 
3= Other Studies (e.g. 
Pharmacoepidemiology, 
Pharmacoeconomics, Intensive 
Monitoring)  
 
4= Report from Aggregate Analysis 
312.32(c)(1)(i)(C) or for several 
events submitted as per 
312.32(c)(1)(i)(B) if a Narrative 
Summary report is provided. 
 
5=Cross-reported IND safety report 
 
2.  For an IND safety report that is a result of an aggregate analysis as per 312.32(c)(1)(i)(C) or 
for several events submitted as per 312.32(c)(1)(i)(B) if a narrative summary report is 
provided:  
a.  Submit one IND safety report with the IND where the event occurred in A.2.3.2 
<sponsorstudynumb> (or the parent IND if the events occurred in multiple INDs).  
For this IND safety report, populate the data elements below in addition to other 
relevant information regarding the event and suspect product. 
i.  Use data element = 4 in A.2.3.3<observestudytype> 
ii.  Use the term AGGREGATE in B.1.1 <patientinitial> 
b.  Section VII.A.2. of the FDA Guidance for Industry  Safety Reporting Requirements 
for INDs and BA/BE Studies (December 2012) discusses several submission 
requirements for IND safety reports that are a result of an aggregate analysis.  The 
following two sections describe these submission elements and how they are 
accomplished with electronic submission to FAERS.  
1.  The guidance states that IND safety reports that are a result of an 
aggregate analysis should contain a narrative description of the event 
and the results of the analysis (hereafter referred to as a narrative 
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summary report). For IND reports submitted to FAERS, attach the 
narrative summary report to the IND safety report as a PDF attachment 
(do not put the narrative summary report in the E2B narrative field). 
a.  These instructions also apply to several events submitted as per 
312.32(c)(1)(i)(B) if a narrative summary report is provided. 
2.  The guidance states that all the individual cases that were analyzed in 
the aggregate analysis should be submitted. Use the repeatable block 
A.1.12 to link all the safety report numbers for the individual 
supportive ICSRs (i.e. the numbers in A.1.0.1 for all the individual 
cases that are summarized in the narrative summary report).  
a.  These instructions also apply to several events submitted as per 
312.32(c)(1)(i)(B) if a narrative summary report is provided. 
b.  IND safety reports previously submitted as ICSRs to FAERS 
do not have to be resubmitted (place the safety report numbers 
for these previously submitted reports in A.1.12).  
c.  For IND safety reports previously submitted in eCTD format, 
the sponsor should list the eCTD sequence number and date of 
submission in the narrative summary report. (The eCTD 
sequence number is the unique four-digit number for each IND 
submission the sponsor submits in the us-regional.xml file for 
the eCTD submission.) 
d.  IND safety reports previously submitted on paper should be 
attached to the IND safety report as PDF attachments. 
Table 144.  Case Scenario 2. For IND Safety Reports Submitted to FAERS 
Data 
DTD Descriptor 3.0  Title  Element Values for DTD  
Element 
A.1.12  <linkreportnumb>  Identification  Used to link all individual cases 
number of  (safetyreportid) that make up an IND 
the report(s)  Safety Report submitted as a result of an 
which are  Aggregate Analysis as per 
linked to this  312.32(c)(1)(i)(C) or for several events 
report  submitted as per 312.32(c)(1)(i)(B) if a 
narrative summary report is provided 
A.2.3.2  <sponsorstudynumb>  Sponsor  IND number under which the Clinical Trial 
Study  where the event occurred is conducted 
Number 
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Data 
DTD Descriptor 3.0  Title  Element Values for DTD  
Element 
A.2.3.3  <observestudytype>  Study Type  1= Clinical Trials 
in Which the   
Reaction(s)  2= Individual Patient Use (e.g. 
were  Compassionate Use or Named Patient 
Observed  Basis)  
 
3= Other Studies (e.g. 
Pharmacoepidemiology, 
Pharmacoeconomics, Intensive 
Monitoring)  
 
4= Report from Aggregate Analysis 
312.32(c)(1)(i)(C)  
 
5=Cross-reported IND safety report 
B.1.1  <patientinitial>  Patient  For a Report from an Aggregate Analysis, 
Identifier  the element value should be 
AGGREGATE 
 
3.  For adverse events that occur with a marketed drug being evaluated under an IND that meets 
both IND and post-marketing safety reporting requirements (21 CFR 312.32 and 314.80, 
600.80, or 310.305), sponsors must submit two separate ICSRs: 
a.  for the marketed drug for the NDA/BLA  
and 
b.  for the study drug for the IND (IND number in A.2.3.2) 
   
Final Version 1.7          46   
APPENDIX III. CASE SCENARIOS FOR SAFETY REPORTS FROM IND-EXEMPT 
BA/BE STUDIES TO FAERS 
Table 15 illustrates the ICH E2B data elements and element values for each IND-exempt BA/BE 
study exposure scenario described below:  
 
Scenario 1: Exposure to a study drug: 
This scenario applies to all drugs specified in the study protocol. For example, if a BA/BE study 
protocol for a generic opiate includes administration of naltrexone to each study subject prior to 
administration of a test or reference drug, naltrexone is a study drug, although it is not the test or 
reference drug.  Similarly, a selective 5-HT3 receptor antagonist to prevent nausea and vomiting 
is considered a study drug if the BA/BE study protocol states that the drug is administered to 
each study subject prior to administration of a test or reference drug. 
 
Scenario 2: Exposure to an other drug: 
Other drugs are drugs taken by or administered to a subject that are not part of study conduct per 
protocol.  For example, a subject with a diagnosis of hypertension has normal blood pressure 
while treated with a beta blocker.  The subject meets study enrollment criteria and continues to 
take his beta blocker during study participation.  In this situation, the beta blocker is an other 
drug.  Similarly, if a subject develops symptoms of heartburn during participation in a BA/BE 
study and is permitted, by the investigator, to use a nonprescription antacid or H2 blocker for 
symptomatic relief, the nonprescription drug taken by the subject is an other drug.  
 
Scenario 3: No exposure to a study drug: 
A serious adverse event a subject experiences after enrollment to the study, but prior to exposure 
to a study drug, is subject to the expedited safety reporting requirement. To report a serious 
adverse event with no study drug exposure, the submitter should select values as shown in the 
Table 15, Scenario 3.   
 
 
 
 
 
 
 
Final Version 1.7          47   
Table 155.  ICH E2B Data Element & Value Selections for IND-Exempt BA/BE Study 
Exposures 
Drug Exposure Scenario  Data Element  Element Values 
B.4.k.1  Select one element value 
B.4.k.2.1  Proprietary medicinal product name 
B.4.k.2.2  Drug substance name 
Scenario 1: 
Select one from the following: 
Exposure to a study 
1 = Test drug 
drug  
B.4.k.19 
2 = Reference drug 
3 = Placebo/Vehicle 
4 = Control (negative or positive) 
Scenario 2:  B.4.k.1  Select one element value  
Exposure to an other  B.4.k.2.1  Proprietary medicinal product name 
drug 
B.4.k.2.2  Drug substance name 
B.4.k.19  5 = Other drug 
Scenario 3:  B.4.k.1  4 = Drug not administered 
No exposure to a study  B.4.k.2.1  Proprietary medicinal product name 
drug  
B.4.k.2.2  Drug substance name 
B.4.k.19  1 = Test drug 
 
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