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CVM GFI #149 (VICH GL33) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Testing March 2009

Docket Number:
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

The hazards associated with the consumption of food containing residues of veterinary drugs are generally assessed in laboratory animals treated with the drugs. International harmonization of testing requirements aims to assure that the development and registration of valuable animal drugs is achieved with maximum efficiency. The efficiency of the approval process has an impact on the expenditure of resources, time from discovery to new product approval, and the introduction of innovative drugs into the market.

Current toxicological testing for veterinary drugs are based on the toxicological tests for human medicines, food additives and pesticides. This guidance suggests use of those tests particularly relevant to the identification of a no-observed adverse effect level (NOAEL) for veterinary drugs.

The scope of this guidance includes: 1) basic tests recommended for all new animal drugs used in food-producing animals in order to assess the safety of drug residues present in human food, 2) additional tests that may be recommended depending on specific toxicological concerns such as those associated with the structure, class, and mode of action of the drug, and 3) special tests which might be recommended to assist in the interpretation of data obtained in the basic or additional tests.

Guidance on the design of protocols for basic and selected additional tests will be provided in separate VICH guidances. Selection and protocol design of special tests and any other tests will be left to the discretion of the various regulatory authorities and/or drug sponsors.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2002-D-0186.


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