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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>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>For veterinary medicines significant
progress in non-animal testing has been made in recent years, including the possibility
of replacing animals 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. Many Marketing Authorisation Holders for
these specific medicines have already, and more recently, introduced these changes
to their authorised medicines, which will reduce the number of animals used. Implementation
of new tests for existing products can be a complicated process, requiring extensive
validation and it is not always possible to replace all of the existing animal tests
with in vitro non-animal replacements for each existing authorised product. The relevant
UK Competent Authority for regulation of these medicines will continue to monitor
the use of animals in these tests and to recommend use of non-animal tests where possible.</p><p><em>
</em></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>LD50
testing is not required for preclinical development of novel medicines. Quality control
testing of some authorised medicines relies on LD50 testing to ensure each batch meets
expected quality standards<em>.</em> 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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