西班牙药监局加入全球监管联盟声明，推动以替代方法减少药物试验用动物
西班牙药品与医疗器械局（AEMPS）10月2日发布消息称，国际药品监管机构联盟（ICMRA）发表联合声明，敦促药物研发企业、生产商、监管机构和国家药品检验实验室加快开发和采用动物实验的替代方法，用于人用药品。该机构是这一全球监管联盟的成员。
声明的长期目标是，在保证质量、安全和有效性的前提下，在药品全生命周期的所有阶段取代动物实验。声明特别提出，要推动批次放行环节采用无动物试验方法，只有当不存在等效或更优的无动物方法、且有科学依据时，才应批准使用体内（动物）批次放行试验，并对现行的相关要求进行审查和修订。
这份声明由欧洲药品管理局（EMA）牵头，联合英国 MHRA、爱尔兰 HPRA 和瑞士 Swissmedic 共同起草，并经 ICMRA 全体成员通过。声明的原则与「3R」理念一致，即替代、减少和优化动物使用，同时照顾各国和地区推进节奏不同的现实。
据声明引述的数据，2015年至2023年间，每年用于药品监管目的的动物数量已大约减少一半。AEMPS 表示，将与联盟成员一道推动替代方法的验证与监管接受，让动物实验的减少不以牺牲患者安全为代价。
（来源：西班牙药品与医疗器械局）
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)
来源：西班牙药品与医疗器械局
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图片来源：图：APHIS-Moore Air Base in Texas-Plant Protection and Quarantine Science and Technology Insect Management and Molecular Diagnostics Laboratory (20230621-CDP-APHIS-0489).jpg。Public domain | USDAgov，Wikimedia Commons。 / Photo: APHIS-Moore Air Base in Texas-Plant Protection and Quarantine Science and Technology Insect Management and Molecular Diagnostics Laboratory (20230621-CDP-APHIS-0489).jpg. Public domain | USDAgov, via Wikimedia Commons.
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