Considerations in Animal-Based Preclinical Safety Testing: The United Kingdom Perspective

In the United Kingdom, the Home Office regulates the use of animals for experimental and other scientific purposes. Applicants must satisfy the regulatory authority that the animal use is justified and scientifically sound, and that the specific objectives cannot be realized by methods not requiring the use of living animals, or by protocols and endpoints likely to cause less animal suffering. Once granted, project license authorities remain valid for up to five years. In the context of species selection for preclinical safety testing, applicants must make transparent the principles and practices that will be used to select the most relevant species, and the most appropriate and refined plans of work and protocols.