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 currently require the use of animals, and a large number of animals are used for this purpose 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 is currently in an information-gathering phase. In 2021, a survey of biologics manufacturers was conducted to better understand the opportunities and barriers to adoption of replacement, reduction, and refinement 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 will be conducted in early 2022. Data collected will be anonymized and published in an appropriate scientific peer-reviewed journal or as a report on the NC3Rs website, and/or presented at scientific meetings or webinars.