Spain's Medicines Agency Joins Global Regulators' Push to Replace Animal Testing in Human Medicines
The Spanish Agency of Medicines and Medical Devices (AEMPS) reported on October 2 that the International Coalition of Medicines Regulatory Authorities (ICMRA), of which it is a member, has published a joint statement urging drug developers, manufacturers, regulators and national control laboratories to accelerate the development and adoption of alternatives to animal testing for human medicines, wherever scientifically possible.
The long-term goal of the statement is to replace the use of animals in all phases of a medicine's life cycle, while maintaining guarantees of quality, safety and efficacy. It places particular emphasis on promoting animal-free methods for batch release testing, arguing that in vivo batch release tests should only be approved where no equivalent or superior animal-free methodology exists and their use is scientifically justified, and that existing requirements should be reviewed and amended.
The statement was led by the European Medicines Agency (EMA) together with the UK's MHRA, Ireland's HPRA and Swissmedic, and was adopted by the ICMRA plenary. It follows the '3R' principles of replacement, reduction and refinement, while recognising that different regions and countries will move towards animal-free development, authorisation and batch release at different speeds.
According to figures cited in the statement, the number of animals used each year for pharmaceutical regulatory purposes fell by roughly half between 2015 and 2023. AEMPS said it will work with coalition partners to validate alternative methods and secure their regulatory acceptance, so that reducing animal testing never comes at the cost of patient safety.
(Source: Spanish Agency of Medicines and Medical Devices)
Source: Spanish Agency of Medicines and Medical Devices
Published by GSM · USA (original Chinese edition)
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