August 16, 2019
The U.S. Food and Drug Administration announced today the availability of final guidance for industry (GFI) #257, “Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species.” This guidance document provides recommendations on what should be included in a marker residue depletion study design for aquatic food-producing species.
A marker residue depletion study is one of the studies recommended to provide human food safety information about the quantity and nature of residues in tissues derived from aquatic species treated with veterinary drugs. Specifically, a marker residue depletion study provides data that can be used to demonstrate that the depletion of the marker residue post-treatment is below the tolerance (the level of drug residue that may remain in an animal’s tissue and still be safe to eat) and that can be used to calculate a withdrawal period (the time that must be observed after an animal is last administered a drug before it can be slaughtered for food).
The guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). Established in 1996, VICH is a trilateral program aimed at harmonizing technical requirements for veterinary products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives. This VICH guidance document is intended to provide study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements in all VICH regions.
The FDA published the notice of availability for the draft version of GFI #257 in the Federal Register on July 24, 2018, and requested public comment on the draft guidance. The public comment period closed on September 24, 2018. The FDA did not receive comments on the draft guidance. However, comments received by other VICH member regulatory agencies were considered as the guidance was finalized.
In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote the international harmonization of regulatory requirements. The FDA has participated in efforts to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development, including pharmaceuticals for animals. One of the goals of harmonization is to identify, and then reduce, differences in technical requirements for drug development, including animal drug development, among regulatory agencies in different countries.
For more information:
- Guidance for Industry #257: Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species
For questions, Contact CVM.