MHRA joins global regulators in call to advance alternatives to animal testing

The MHRA has today joined international medicines regulators in a joint statement calling for alternatives to animal testing throughout the lifecycle of human medicines to be advanced and implemented, wherever and as soon as possible.

The statement, from the International Coalition of Medicines Regulatory Authorities (ICMRA), was developed by the European Medicines Agency (EMA), the MHRA, the Irish Health Products Regulatory Authority and Swissmedic, and has been adopted by the ICMRA plenary.

It sets out the long-term goal of replacing animal testing at every stage of a medicine's lifecycle, from initial screening and early development, through non-clinical testing, to licensing and post-authorisation activities.

For new medicines, ICMRA calls on:

• medicines developers globally to use methods that do not involve animals and are acceptable in a regulatory context, while safeguarding scientific quality
• international regulators to support these efforts as far as possible.

Recognising that the greatest reduction in animal use would come from adopting non-animal methods for batch release testing, ICMRA also calls on regulators to:

• encourage the development and use of non-animal tests for batch release, and challenge proposals to use animals
• only approve animal testing for batch release where it is scientifically justified that no equivalent or better non-animal method is available
• review and, where appropriate, amend existing animal testing requirements for batch release.

The MHRA previously released guidance to help medicines developers understand what it requires when assessing applications that rely on non-animal methods, known as New Approach Methodologies (NAMs).

By offering early review of non-animal data and clarifying how it will be assessed, the MHRA aims to give developers more confidence when making marketing applications based on evidence generated without animal testing. Its scientists are also carrying out research into alternatives, including organ-on-a-chip technology, AI-driven predictive models and 3D bioprinted tissues.

Ensuring patients have access to safe and effective medicines remains the MHRA's priority, and its assessment of new medicines will only consider alternative methods once they are established as reliable.

Notes to editors

1. In March 2026 the MHRA announced action to boost drive to phase out animal testing MHRA action boosts drive to phase out animal testing - GOV.UK. This followed the Government publication of Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods - GOV.UK
2. The ICMRA statement on animal testing for human medicines is now live on the ICMRA website.
3. The MHRA is a member of the ICMRA Executive Committee which promotes international cooperation among medicines regulators.
4. The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
5. The MHRA is an executive agency of the Department of Health and Social Care.
6. For media enquiries, please contact the [email protected], or call on 020 3080 7651.