What is the process for Veterinary Adverse Event Reporting for Manufacturers?
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.
Paper Reporting Forms
CVM will continue to accept adverse drug event reports in paper if the Marketing Authorization Holder (MAH) is unable or unwilling to submit these reports electronically.
A revised version of Form FDA 1932 has been approved for mandatory reporting of adverse drug events (OMB No. 0910-0645) by animal drug manufacturers (also referred to here as Marketing Authorization Holder (MAH)). However, there will be a transitional period of approximately six months to give companies time to accommodate the revisions, as the revisions may require changes to validated databases. During this time, both paper versions of Form FDA 1932 (OMB Nos. 0910-0284 and 0910-0645) will be available on the CVM Website (see Resources for You above) and on the FDA Forms web page. After this transitional period, only the revised version of the paper form will be available for use.
CVM now accepts electronic submission of adverse event information for veterinary drugs. Electronic submission of adverse event information will be possible 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.
However, three-day NADA/ANADA Field Alert Reports must be submitted directly to the appropriate FDA District Field Office or local FDA resident post by telephone or other telecommunication means, and paper form. (See 21 CFR 514.80(b)(1)).
Currently, FDA does not have the electronic capability to share with the FDA District Office or local resident post electronic reports submitted through gateway-to gateway electronic submission or the SRP. If the MAH elects to submit a three-day NADA/ANADA field alert report directly to FDA’s CVM, the MAH may use the gateway-to-gateway submission, the SRP, or the paper form. However, if the MAH chooses to submit this report directly to FDA’s CVM, this does not alleviate the MAH’s responsibility to submit this report (via telephone or other telecommunication means, and paper form) to the FDA District Field Office or local FDA resident post (see 21 CFR 514.80(b)(1)).
If submitting a three-day NADA/ANADA field alert report using the paper form, we prefer that the revised Form FDA 1932 (OMB No. 0910-0645) be used.
CVM GFI #188 Draft Guidance for Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine (PDF - 167KB)
Draft 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
HL 7 ICSR Vocabularies (XLS - 1277KB)
MS Excel spreadsheet listing the vocabularies of compliant GL-42 ICSR data elements section - for use in filling out Form FDA 1932
Electronic Transmission Implementation Specifications (Step By Step) (PDF - 816KB)
Technical instructions for building compliant HL7 animal ICSRs
Electronic Transmission Implementation Specifications (Validation Procedures) (PDF - 1016KB)
Validation procedures for compliant HL7 animal ICSRs
Instructions for Submitting Mandatory Electronic Adverse Event Reports to FDA CVM (PDF - 401KB)
High level instructions to assist in creation and submitting HL7 FDA CVM complaint ICSRs