SciethiQ, under contract with Humane Society International, Basel, Switzerland.
Paul-Ehrlich-Institut, Langen, Germany; European Medicines Agency (EMA), Brussels, Belgium.
Biologicals. 2023 Aug;83:101695. doi: 10.1016/j.biologicals.2023.101695. Epub 2023 Jul 27.
Regulatory authorities require veterinary batch-release testing to confirm vaccine potency and safety, but these tests have traditionally relied on large numbers of laboratory animals. Advances in vaccine research and development offer increasing opportunities to replace in vivo testing, and some stakeholders have made significant progress in incorporating 3Rs elements in quality control strategies. A three-part event series entitled "3Rs Implementation in Veterinary Vaccine Batch-Release Testing: Current state-of-the-art and future opportunities" was jointly organized by the Animal-Free Safety Assessment Collaboration, HealthforAnimals, and the International Alliance of Biological Standardization. Two webinars and a workshop aimed to outline the state-of-the-art non-animal approaches for veterinary batch-release testing. The events included information on the state of the deletion of obsolete safety testing and the current initiatives implemented by European, North American, and Asian-Pacific stakeholders on 3Rs implementation and regulatory acceptance. The events contributed to a better understanding of the barriers to 3Rs implementation. Participants highlighted the need for open communication, continued collaboration between stakeholders, and international harmonization of regulatory requirements to help accelerate acceptance. Despite the challenges, the countries represented at this three-part event have shared their commitments to advancing the acceptance of alternative methods.
监管机构要求进行兽医批次放行测试以确认疫苗效力和安全性,但这些测试传统上依赖大量的实验动物。疫苗研究和开发方面的进展为替代体内测试提供了越来越多的机会,一些利益相关者在将 3R 要素纳入质量控制策略方面取得了重大进展。题为“在兽医疫苗批次放行测试中实施 3R:现状和未来机会”的三部分系列活动由无动物安全评估合作组织、动物健康联盟和国际生物标准化联盟联合组织。两次网络研讨会和一次研讨会旨在概述兽医批次放行测试的非动物方法的最新进展。活动包括有关淘汰过时安全测试的现状以及欧洲、北美和亚太地区利益相关者在 3R 实施和监管接受方面开展的当前举措的信息。这些活动有助于更好地了解实施 3R 的障碍。与会者强调需要进行开放的沟通,利益相关者之间继续合作,以及对监管要求进行国际协调,以帮助加速接受。尽管存在挑战,但参加这三次活动的国家都表示致力于推进替代方法的接受。