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Clinical trials in animals

The Veterinary Medicines Regulations 2013 (VMR) 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.

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

The types of medicinal product falling under the definition of a veterinary medicine and tested during a clinical trial might include:

• a veterinary medicine under development
• an authorised veterinary medicine
• a human medicine

ATCs in the UK

An Animal Test Certificate (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

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; these are set out below.

Types of ATC application

Commercial clinical trials

Commercial clinical trials are usually conducted by the pharmaceutical industry to generate the 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 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 (or 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, Australia, Canada, an EEA member country, Japan, New Zealand, and/or the USA and the clinical trial is to be conducted in non?food animals (companion animals or other animals, including their products, declared to never enter the food chain).
3. Non-biological product studied in food?producing animals: The medicinal product is a non?biological veterinary medicine or a human medicine with an existing MA granted in the UK and/or an EEA member country and the trial is to be conducted in food-producing animals, and one of the following applies:

a) The clinical trial is to be conducted in a species included in the existing MA, the dosing regimen to be tested (dose, frequency of administration, and duration of treatment course) is the same as (or lower than) the dosing regimen authorised for use in that species via the same route of administration, and the associated withdrawal periods set out in the SPC will be observed.

b) The medicinal product contains only substances that are listed in Table 1 of the Annex to Commission Regulation 37/2010 (for NI) or the GB MRL list (for GB) and an appropriate withdrawal period has been set. For a type?S ATC application withdrawal periods may be determined by reference to the principles set out in VMD guidance concerning the setting of withdrawal periods under the prescribing cascade.

c) The clinical trial is to be conducted in Horses, the active substance(s) tested are listed as essential for the treatment of equidae or are substances bringing added clinical benefit according to regulation (EC) 122/2013, and a 6 month withdrawal period will be applied.

Where the criteria for a type?S ATCapplication cannot be met, a type?B ATC application is usually required. Should the criteria set out above not apply, it is recommended that you contact us at postmaster@vmd.gov.uk before submitting an ATC application.

Sample size

Small-scale non-commercial clinical trials will usually involve no more than 25animals treated with the test product. However, where it is necessary to permit meaningful statistical analyses, larger sample sizes may be accepted, where adequate justification has been provided.

Design

To ensure robust study design and appropriate consideration of how to reduce, refine and replace the use of animals, the work should be conducted to recognised quality standards for published research, such as the Defra Joint Code of Practice for Research (JCoPR). In addition, the VMD expects that the work will be the subject of an ethical review.

Before initiating your trial, you should inform the MA holder of the authorised product under investigation. On completion of the trial we expect that the results will be reported in compliance with the principles set out in the Animal Research: Reporting In Vivo Experiments (ARRIVE) Guidelines.

Type?B

You should submit a type?B ATC application where the nature of a clinical trial or the medicinal product(s) under investigation do not meet the criteria set out above for either a type?A (commercial clinical trial) or a type?S (small?scale non?commercial clinical trial) ATC application.

How to determine type of ATC application required

Contact us at postmaster@vmd.gov.uk if after using these tables you are still unsure which type of application to apply for.

Commercial clinical trials

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