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GUIDANCE DOCUMENT

CVM GFI #143 (VICH GL30) Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms October 2014

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2002-D-0268
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

To assess the safety and efficacy of veterinary medicinal products, the use of controlled lists of terms is important in order to assure consistency, as well as to provide for comparison between products and across product classes. The data fields that warrant controlled lists of terms have been identified in FDA’s Guidance for Industry (GFI) #188, “Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine [(CVM)]” (FDACVM GFI#188) available on the FDA website.

Regulatory authorities (RA) and industry have partnered in the development of the lists and of an appropriate maintenance procedure (through the ad-hoc Controlled Lists of Terms Implementation Task Force from June 2008 to February 2009). The lists have been developed by making use of existing lists from RA and industry.

The controlled lists of terms provide a level of discrimination appropriate to record, search and categorize for trending. The lists have recommended groupings of terms of a manageable size but with sufficient detail to provide for uniform input and analysis. The controlled lists are accessible via the FDA website at Veterinary Adverse Event Reporting for Manufacturers. For the data fields that use controlled lists of terms, user systems can, to facilitate reporting or inputting, use a subset of terms listed in this guidance that are considered relevant to the region and to the products involved. However, when receiving reports electronically that are compliant with the relevant VICH guidances, all systems should be capable of importing and storing the full report, including all terms and codes, without loss of information.

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All written comments should be identified with this document's docket number: FDA-2002-D-0268.

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