Revisions to Nine ICH Veterinary Guidance Documents on Effectiveness of Anthelmintics

While most of us were sleeping, the ICH has been busy revising nine of its guidances titled International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics for different species.

The prepublication of the Federal Register today (here, please scroll down to regular filings on the lefthand side of the page and select Food and Drug Administration), which lists each of the eight species‑specific guidances, states:

“FDA is announcing the availability of a draft guidance for industry GFI #111 (VICH GL19(R1)) entitled ‘Effectiveness of Anthelmintics: Specific Recommendations for [Species inserted] (Revision 1).’  It should be read in conjunction with GFI #90 (VICH GL7), ‘Effectiveness of Anthelmintics: General Recommendations,’ which should be referred to for discussion of broad aspects for providing pivotal data to demonstrate product anthelmintic effectiveness.  The purpose of this guidance is: (1) to be more specific for certain specific [species inserted] issues not discussed in GFI #90 (VICH GL7); (2) to highlight differences with GFI #90 (VICH GL7) on effectiveness data recommendations; and (3) to give explanations for disparities with GFI #90 (VICH GL7).  This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.”

The one “General Recommendations” guidance states:

“The objective of this guidance is to provide 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.”

The eight species include canines, equines, felines, ovines, porcines, bovines, caprines, and chickens–Gallus gallus.  That covers the waterfront.  For those of you in the veterinary industry, this is obviously an important topic.  The revised draft guidances will likely be published on the veterinary medicine pages of the FDA website either later today or tomorrow when the FR notice is scheduled to publish.