FDA Seeks Public Comment on Revised Guidance Documents Focused on Harmonizing Requirements for Anti-parasitic Drugs Used in Animals
August 11, 2022
Today the U.S. Food and Drug Administration is announcing significant revisions to nine guidance documents that have been developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The draft guidance documents focus on anthelmintics, which are anti-parasitic drugs used in animals.
VICH is a trilateral program officially launched in April 1996. The program aims to harmonize technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives.
The draft guidance documents the FDA is announcing today include:
- CVM draft Guidance for Industry (GFI) #90 (VICH GL7)), “Effectiveness of Anthelmintics: General Recommendations;
- CVM draft GFI #95 (VICH GL12) Effectiveness of Anthelmintics: Specific Recommendations for Bovines;
- CVM draft GFI #96 (VICH GL13) Effectiveness of Anthelmintics: Specific Recommendations for Ovines;
- CVM draft GFI #97 (VICH GL14) Effectiveness of Anthelmintics: Specific Recommendations for Caprines;
- CVM draft GFI #109 (VICH GL15) Effectiveness of Anthelmintics: Specific Recommendations for Equines;
- CVM draft GFI #110 (VICH GL16) Effectiveness of Anthelmintics: Specific Recommendations for Porcines;
- CVM draft GFI #111 (VICH GL19) Effectiveness of Anthelmintics: Specific Recommendations for Canines;
- CVM draft GFI #113 (VICH GL20) Effectiveness of Anthelmintics: Specific Recommendations for Felines; and
- CVM draft GFI #114 (VICH GL21) Effectiveness of Anthelmintics: Specific Recommendations for Chickens Gallus gallus.
CVM draft Guidance for Industry (GFI) #90 (VICH GL7 (R1)), “Effectiveness of Anthelmintics: General Recommendations” provides study design recommendations that will facilitate the universal acceptance of the generated effectiveness data to fulfill the national/regional requirements for anthelmintic drugs in animal species. This revision updates data analysis and isolate characterization recommendations, outlines how to approach new indications, and makes additional clarifying changes. This guidance document replaces the version that was made available in October 2001.
The remaining species-specific guidance documents (draft GFI #95, #96, #97, #109, #110, #111, #113 and #114) clarify the definition of adequate infection in individual animals, update considerations for field studies, and make additional clarifying changes. These guidance documents replace the versions that were made available in March 2001 and June 2002.
The FDA participates in efforts to enhance international harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify, and then reduce, differences in technical requirements for drug development among regulatory agencies in different countries. The FDA’s work with VICH aims to ensure regulatory certainty for veterinary products, including predictable and uniform requirements across the E.U., Japan and the U.S. The collective work also helps to reduce animal testing, facilitate trade, and ensure veterinary product safety and consumer confidence in the regulated products.
Although the public may submit comments on any FDA guidance documents at any time, the agency is encouraging the public to submit comment(s) on the draft guidance within 60 days to ensure that the FDA considers your comment(s) before it begins work on the final version of the guidance documents. To submit comments electronically, visit https://ww.regulations.gov and type the following docket number into the search box: FDA-2022-D-1494.
The public may also submit comments by mail using the address below:
Dockets Management Staff
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852.
For more information:
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.