Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether he plans to reassess the requirements established by the European Medicines Agency guidelines implementing EU Directive 2001/83/EC on Medicinal Products for Human Use which specify that two species of mammal, one a non-rodent, must be used in repeated dose toxicity tests with a view to reviewing the use of dogs in such testing.

The requirement to use two mammalian species (one a non-rodent) in repeated dose toxicity is part of the International Conference on Harmonisation guideline on ‘Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorisation for Pharmaceuticals’, ICH M3(R2). The overall objective of this internationally agreed guideline is the promotion of safe and ethical development of new pharmaceuticals while reducing the use of animals in accordance with the 3R principles (reduce/refine/replace).

There are no plans to reassess this requirement at present. The requirement is an integral part of a stepwise process involving an evaluation of both the animal and human safety information. The goals of the nonclinical safety evaluation generally include a characterisation of toxic effects with respect to target organs, dose dependence, relationship to exposure, and when appropriate, potential reversibility. Choice of species for nonclinical investigations are made based on scientific and ethical considerations. This information is important for how to test a candidate medicinal product in human trials, specifically for the estimation of an initial safe starting dose and dose range. The United Kingdom’s National Centre for the Replacement Refinement and Reduction of Animals in Research continues to research the utility of using dogs in such investigations.