Veterinary Adverse Event Reporting for Manufacturers

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Background

Section 512(l) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360b(l)) requires applicants to establish and maintain records and make such reports of data relating to experience with uses and other data or information received or obtained by the applicant with respect to such drug as required by regulation or order. Section 514.80 (b) (21 CFR 514.80(b)) of FDA regulations requires applicants of approved new animal drug applications (NADAs) and approved abbreviated new animal drug applications (ANADAs) to report ADEs and product and manufacturing defects.This continuous monitoring of approved NADAs and ANADAs affords the primary means by which FDA’s Center for Veterinary Medicine (CVM) obtains information regarding potential problems with the safety and efficacy of marketed approved new animal drugs as well as potential product/manufacturing problems.

How to Report an Adverse Drug Experience

Electronic Reporting:

CVM accepts electronic submission of adverse event information for veterinary drugs through the Electronic Submissions System (ESS) and the Rational Questionnaire (RQ) in the Safety Reporting Portal (SRP), a joint FDA-National Institutes of Health initiative.

The ESS integrates with the FDA Electronic Submissions Gateway (FDA ESG) to allow adverse drug experience reports, either individually or in batches, to be transmitted directly from industry to CVM via gateway-to-gateway submission.

The Rational Questionnaire in the SRP provides another option for animal drug manufacturers to submit adverse event reports electronically to CVM.  The Rational Questionnaire is a web-based questionnaire that displays a series of questions to be answered by the person submitting the report.  These questions are intended to ensure proper collection of the information that is needed by FDA to appropriately evaluate the reported incident. Since the SRP only supports transmission of individual reports via the Rational Questionnaire, companies wanting to send batches of multiple reports might prefer the gateway-to-gateway method.

Instruction and documentation are provided under the “Supporting Documents” header at the bottom of this page.

Three-day Field Alert Reports:

Three-day NADA/ANADA Field Alert Reports must be submitted directly to the appropriate FDA District Field Office or local FDA resident post. The information initially may be provided by telephone or other telecommunication means, with prompt written follow up using Form FDA 1932. (See 21 CFR 514.80(b)(1)).

• If the Marketing Authorization Holder (MAH, also referred to as the applicant) elects to submit a three-day NADA/ANADA field alert report electronically via gateway to gateway submission or the Safety Reporting Portal directly to FDA’s CVM, a copy of the report will automatically be sent to the District Office identified in the report.
• If the MAH chooses to submit a paper copy of Form FDA 1932 to FDA’s CVM, this does not alleviate the MAH’s responsibility to submit this report (via paper form) to the FDA District Field Office or local FDA resident post.  If submitting a three-day NADA/ANADA field alert report using the paper form, we prefer that the revised Form FDA 1932 (OMB No. 0910-0284) be used. 

How to report electronically:

Safety Reporting Portal:  The SRP has separate procedures for creating a user account that do not require registration with the FDA ESG.  Users simply follow the directions to provide contact information and create a password. An instructional video describing how to use the SRP is available:

Gateway-to-gateway:

Refer to the document Instructions for Submitting Mandatory Electronic Adverse Event Reports to FDA CVM found below.

General Instructions

• Instructions for Electronic Submission of Mandatory Adverse Event Reports to FDA CVM (PDF - 13 pages)
  High level instructions to assist in creation and submitting HL7 FDA CVM complaint ICSRs
• CVM Registration Web Form for Electronic Adverse Events (ZIP - 2KB)

Supporting Documents

• CVM GFI #188 Guidance for Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine
  Final guidance document on providing information (Data Elements) to the FDA CVM via Form FDA 1932 - Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report
• Form FDA 1932 (OMB 0910-0284)- Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report (PDF - 945KB)
• CVM Internal Terms for Use in Veterinary ADE Reporting
• FDA CVM Vocabularies for HL7 GL42
  MS Excel spreadsheet listing the vocabularies of compliant GL-42 ICSR data elements - for use in filling out Form FDA 1932
• CVM GFI #143 - VICH GL30 - Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms
• CVM GFI #214 - VICH GL35 - Pharmacovigilance of Veterinary Medicinal Products Electronic Standards for Transfer of Data
  Contact CVMAESupport@fda.hhs.gov for Electronic Transmission Implementation Specifications technical documents: Step By Step Document and Validation Procedure Document

Contact FDA for technical support questions

• CVM Electronic Submissions: 240-402-7062
• CVM ADE Support: CVMAESupport@fda.hhs.gov

Additional Resources

• Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report (PDF - 945KB)
• Adverse Event Reports for Animal Drugs and Devices
• Electronic Submissions
• Safety Reporting Portal