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Clinical trials in animals

A clinical trial is a study usually conducted in client-owned animals, that aims to confirm under field conditions the safety and/or efficacy of a veterinary medicine under normal conditions of animal husbandry or as part of routine veterinary practice.

You need an Animal Test Certificate (ATC) to carry out a clinical trial of a veterinary medicine in animals in GB and/or NI. You must submit your application for an ATC to the VMD.

Veterinary medicines investigated in clinical trials

Definition of a veterinary medicine

The Veterinary Medicines Regulations 2013 (VMR), as amended, define a veterinary medicine as:

• any substance or combination of substances presented as having properties for treating or preventing disease in animals;
• any substance or combination of substances which may be used in or administered to animals with a view either to restoring, correcting, or modifying physiological functions by exerting a pharmacological, immunological, or metabolic action, or to making a medical diagnosis; or
• any substance or combination of substances that may be used for the purpose of euthanising an animal.

Products investigated in a clinical trial can be prescription or non-prescription, authorised or unauthorised, veterinary or human products. They may also be veterinary or human medicines under development.

Importantly, products investigated in a clinical trial may fall under the definition of a veterinary medicine based solely on the reason why they might be prescribed by a veterinary surgeon in relation to the clinical condition being investigated.

ATCs in the UK

An ATC is normally required if the design of a clinical trial in any way prevents participating vets from using their full professional judgement during clinical decision?making concerning the prescription of veterinary medicines. This may occur if animals are randomised, or vets are blinded, to treatment groups or when the medicines used during a clinical trial will not be labelled in accordance with the VMR, as might be necessary to facilitate blinding of study participants.

In this context, even if the same veterinary medicine is used in each study group, but aspects of its administration during a clinical trial are randomised between groups and/or blinded, an ATC is normally required. For example, the study protocol may dictate randomisation/blinding of the route of administration, the administration technique, and/or the dosage regimen; dose, frequency of administration, and duration of treatment course.

An ATC permits:

• the use of a medicine during a clinical trial, including the use of a medicine outside the terms of its marketing authorisation
• the procurement and supply of that medicine
• the import of any medicine specified in the certificate in accordance with the conditions of that certificate
• the produce from treated animals to enter the food chain, if appropriate
• the use of randomisation and/or blinding within the study protocol
• the administration of a placebo product, where specified

There are three different types of application that can be used to obtain an ATC; type?A, type?B, and type?S. The type of ATC application required is dependent on several factors as set out below.

When an ATC is not required

In certain situations, an ATC is not required.

A clinical trial involving a non?medicinal therapy, that does not meet the definition of a veterinary medicine, does not require an ATC. For example, an ATC is not required for a clinical trial of a purely surgical intervention, where no aspect of the administration of a veterinary medicine is under investigation. Additionally, an ATC is not required for a clinical trial investigating an animal feed additive, such as a nutritional supplement, provided the feed additive(s) to be tested does not fall within the definition of a veterinary medicine, when used in accordance with the study protocol.

The retrospective analysis of clinical observations is not a clinical trial, and therefore does not require an ATC.

Depending on the study design, a clinical trial carried out by a vet who will administer a veterinary medicine in accordance with the provisions of the prescribing cascade, or a clinical trial involving a veterinary medicine used fully in accordance with its Summary of Product Characteristics (SPC) may not require an ATC.

You can find more information on The Cascade: Prescribing unauthorised medicines.

Studies licensed in full by the Home Office under the Animals (Scientific Procedures) Act 1986 (ASPA), including laboratory studies, do not require an ATC if they are conducted in non-food animals or animals, including their products, declared never to enter the food chain.

Furthermore, for those studies in food?producing animals that have been licensed in full under the ASPA, an ATC is not required provided the veterinary medicine to be used has a marketing authorisation (MA) in GB, NI, or the EEA and is to be administered in accordance with this MA.

Additionally, the authorised dosing regimen for the species and route of administration must be used, or a lower dose, and the withdrawal periods set out in the SPC must be observed.

For Home Office licensed studies conducted in food-producing animals where these criteria are not met, then a type-B ATC application should be submitted to determine or justify an appropriate withdrawal period.

Further information on how the Home Office regulates the use of animals in research can be obtained from the Home Office Animals (Scientific Procedures) Inspectorate and associated online guidance.

Contact us at postmaster@vmd.gov.uk if you are still unsure whether your proposed study design requires an ATC.

Types of ATC application

Commercial clinical trials

Commercial clinical trials are usually conducted by the pharmaceutical industry to generate the confirmatory data required to support a marketing authorisation (MA) application. This may be a new MA application for a veterinary medicinal product under development, or a change to an existing MA for an authorised product. To obtain an ATC for a commercial clinical trial you will need to submit a type?A or type?B ATC application.

Non-commercial clinical trials

Practising vets or researchers may wish to carry out a non-commercial and typically small-scale clinical trial of a medicine. Such a study may be conducted to inform clinical practice or be undertaken for academic purposes. To obtain an ATC for these types of non?commercial clinical trial you will need to submit a type?S ATC application. However, where the criteria for a type?S ATC application cannot be met, a type?B ATC application is usually required.

Further details regarding the types of ATC application are provided below.

Type-A

You should submit a type?A ATC application if you wish to conduct a commercial clinical trial of a medicinal product that is already authorised (has an existing MA) for veterinary or human use in the UK/GB/NI or an EEA member country, and one of the following applies:

1. The product is a biological veterinary medicine, inclusive of immunological products and exclusive of human medicines, and the clinical trial is to be conducted in animals of the target species included in the existing MA, using a dosing regimen authorised for that species (or a lower dose) and the authorised route of administration.
2. The product is a non?biological veterinary medicine, the clinical trial is to be conducted in animals from a food-producing species, and the dosing regimen to be tested; dose, frequency of administration, and duration of a treatment course, is the same as/lower than, the dosing regimen authorised for use in that species via the same route of administration.
3. The product is a non?biological veterinary medicine or human medicine and the clinical trial is to be conducted in a companion animal species.

Where the criteria for a type?A ATC application cannot be met, a type?B ATC application is usually required.

Type?S

You should submit a type?S ATC application if you are a practising vet or researcher wishing to carry out a small-scale non-commercial clinical trial of a veterinary medicine or a human medicine and one of the following applies:

1. Biological veterinary medicine: The medicinal product is a biological veterinary medicine, inclusive of immunological products and exclusive of human medicines, with an existing MA granted in GB, NI, or an EEA member country and the clinical trial is to be conducted in animals of the target species included in the existing MA, using a dosing regimen authorised for that species (or lower) and the authorised route of administration.
2. Non-biological product studied in non?food animals: The medicinal product is a non?biological veterinary medicine or a human medicine and has an existing MA granted in the UK/GB
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