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<p>There is no United Kingdom legislation that mandates animal testing. We do, however,
work to a series of International Council of Harmonisation and Committee for Medicinal
Products for Human Use guidelines that describe ways to evaluate different non-clinical
aspects of medicines, many of which use animals. These aspects include safety pharmacology,
repeat dose toxicity, genotoxicity, carcinogenicity, reproductive toxicity, phototoxicity,
and immunotoxicity.</p><p>The non-clinical assessors have always taken the approach
that data from a suitably validated model that has been demonstrated to be predictive
could be submitted in lieu of animal data. On a case-by-case basis, a non-clinical
assessor will also accept appropriate justifications for not conducting animal tests,
for example, no pharmacologically relevant species.</p><p>In terms of promoting use
of non-animal methods, we do not consider this to be within the remit of non-clinical
assessors. Rather, it is for those using these methods to tell the Medicines and Healthcare
products Regulatory Agency (MHRA) how they have validated them, or at least why they
rely on the results and an assessor will then judge whether the data is appropriate
to support the trial. The MHRA supports the developers of products by its offer of
scientific advice services, the Innovation Office and the Innovative Licensing and
Access Pathway.</p><p>The MHRA fully supports the National Centre for the 3Rs (Replacement,
Reduction and Refinement), and agency staff play an active role in projects to support
adoption and adherence to the 3Rs principles in medicines regulation worldwide.</p>
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