EMA 支持 ICMRA 联合声明，呼吁在药品生命周期推进动物试验替代方法

EMA has endorsed a joint statement from the International Coalition of Medicines Regulatory Authorities (ICMRA) calling on medicine developers, manufacturers, regulators and national control laboratories to continue to advance and implement alternative methods or approaches to animal testing throughout the lifecycle of human medicines, wherever, and as soon as possible.

EMA has a longstanding commitment to the 3Rs principles – to replace, reduce and refine the use of animals in medicines development and regulation. Because medicines are developed and regulated in a global environment, meaningful progress in reducing animal use depends on the worldwide development and regulatory acceptance of scientifically valid, 3Rs-compliant approaches. Promoting international alignment and harmonisation of regulatory approaches through ICMRA are central to this effort.

The development of the joint statement was led by EMA, the UK Medicines and Healthcare products Regulatory Agency (MHRA), the Irish Health Products Regulatory Authority (HPRA) and Swissmedic, the Swiss Agency for Therapeutic products. Adopted by the ICMRA plenary, the statement sets out the long-term goal of replacing animal testing throughout all stages of a medicine’s lifecycle: from initial candidate screening and early development, through pre-clinical and non-clinical testing to licensing and post-authorisation activities. Achieving this will require a cautious and stepwise transition to non-animal methods that are scientifically valid and acceptable for regulatory authorities, supported by robust evidence and open global interaction between regulators, medicine developers and innovators of alternative approaches.

For new medicines, from development to authorisation, ICMRA calls on:

• medicine developers globally to employ methods that do not involve the use of animals and that are acceptable in a regulatory context while safeguarding scientific quality;
• international medicines regulators to support and facilitate these efforts insofar as possible.

Recognising that the greatest impact in reducing the use of animals to meet regulatory requirements would be achieved by the adoption of non-animal methods for batch release testing, ICMRA also calls on international regulators to:

• encourage the development and adoption of non-animal tests for batch release purposes, and to challenge instances where animal use for batch release testing is proposed;
• only approve in vivo batch release testing when scientifically justified that there is no equivalent or superior non-animal methodology available;
• review and amend as appropriate existing in vivo testing requirements for batch release. 

The ICMRA statement acknowledges that different regions and countries will move at different paces to accept a transition towards drug development, licensing and batch release without testing in animals. ICMRA encourages medicines manufacturers, developers and regulators to work together to enable this progressive paradigm shift, and to support harmonised implementation as much as possible.

At the EU level, a clear direction has been set to progress towards innovative non-animal methods. In June, the European Commission presented a roadmap towards phasing out animal testing for chemical safety assessments, which lays out tangible steps to ensure this transition. In addition, much progress has already been achieved to reduce the use of animals in the context of batch release testing. From 2015 to 2023, overall, the number of animal uses per year for regulatory purposes for pharmaceuticals approximately halved.