FDA Announces Draft Guidance on Pharmaceutical Development for Veterinary Drug Products

May 3, 2024

Today, the U.S. Food and Drug Administration is announcing the availability of draft guidance for industry (GFI) #290 (VICH GL61) entitled “Pharmaceutical Development.” This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).

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. In support of wider international harmonization of regulatory requirements, VICH guidelines are also available for use by other countries.

The draft guidance describes the suggested contents for the Pharmaceutical Development section if it is included in the Chemistry, Manufacturing, and Controls technical section of an animal drug application. This section is intended to provide a comprehensive understanding of the product and manufacturing process for reviewers and investigators of animal drug products. The guidance also indicates areas where greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches.

The FDA has participated 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comments on any FDA guidance document at any time, the agency is encouraging the public to submit comment(s) on the draft guidance within 60 days to ensure that the FDA considers your comment(s) before it begins work on the final version of the guidance document. To submit comments electronically, visit https://www.regulations.gov and type the following docket number into the search box: FDA-2024-D-1133.

The public may also submit comments by mail using the address below:

Dockets Management Staff
HFA-305
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.