Review of animal testing requirements in World Health Organization guidelines and recommendations for biologics
Biologics such as vaccines, cytokines, enzymes, and hormones are tested routinely after approval to ensure the safety and potency of products. Many of these tests use animals, and thus a large number of animals are used for biologics testing each year.
FDA and NIEHS are supporting a project led by the World Health Organization and NC3Rs to carry out an independent and comprehensive review of animal use requirements within World Health Organization guidelines for biologics and to make recommendations for where non-animal approaches can be adopted. The project began with a survey of biologics manufacturers to better understand the opportunities and barriers to adoption of replacement, reduction, and refinement (3Rs) alternatives and use of non-animal approaches in quality control, batch, and lot release testing of biologics. A similar survey of national regulatory authorities and national control laboratories was conducted in early 2022. A September 2022 virtual workshop focused on requirements in North and South America. Biologicals regulatory agencies and manufacturers from the region discussed their perspectives on current testing strategies and how changes to WHO guidelines could be implemented to support wider adoption of 3Rs and non-animal approaches. The findings from this project were presented to the World Health Organization Expert Committee on Biological Standardization in October 2023.