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<p>The UK supports work to develop New Approach Methodologies which can provide information
on chemical hazards and risk assessment without the use of animals.</p><p> </p><p>The
Veterinary Medicines Directorate (VMD) is the UK regulatory authority for veterinary
medicines. The VMD assesses applications submitted by the veterinary pharmaceutical
industry in line with national and international regulations and guidance to ensure
safe and effective veterinary medicines of good quality are marketed. These requirements
may therefore necessitate animal testing either to develop and register new veterinary
medicines or for routine product quality control, to ensure the continued quality,
safety and efficacy batch to batch. Non-animal tests are not always available. The
VMD is committed to phasing out the use of animals for testing purposes where possible,
in accordance with the principles of 3Rs (Replacement, Reduction, Refinement). Furthermore,
the UK is a signatory to the European Pharmacopoeia (which sets minimum quality standards
of medicines) and the European Convention for the Protection of Vertebrate Animals
used for Experimental and Other Scientific Purposes. This commitment to the 3Rs is
also enshrined in the UK’s Animals (Scientific Procedures) Act 1986 under which scientific
procedures in animals are regulated.</p><p> </p><p>The Minister of State for Science,
Research and Innovation (the hon. Member for Arundel and South Downs, Andrew Griffith)
recently announced that the Government will publish a plan to accelerate the development,
validation and uptake of technologies and methods to reduce reliance on the use of
animals in science, which will be published in the summer. He also requested that
we double our investment in research to achieve these approaches next year to £20
million across the system in 2024/25.</p><p> </p><p>LD50 testing is not required for
preclinical development of novel medicines. Some authorised medicines in the UK include
(LD50) quality control tests which require the use of animals, conducted to ensure
the quality, safety and efficacy of specific medicines. UK regulators follow the principles
of the 3Rs. Significant progress has been made on validating alternative methods which
do not use animals, including the possibility of replacing mice by in vitro suitable
cell cultures in LD50-type testing methods, and the relevant regulatory quality standards
and testing requirements have been revised accordingly for these specific medicines.</p>
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