Schutte Katrin, Szczepanska Anna, Halder Marlies, Cussler Klaus, Sauer Ursula G, Stirling Catrina, Uhlrich Sylvie, Wilk-Zasadna Iwona, John David, Bopst Martin, Garbe Joerg, Glansbeek Harrie L, Levis Robin, Serreyn Pieter-Jan, Smith Dean, Stickings Paul
EU Commission, Directorate General for the Environment, Avenue Beaulieu 9, B-1160 Brussels, Belgium.
European Federation of Pharmaceutical Industries and Associations (EFPIA), Rue du Trône 108, B-1050 Brussels, Belgium.
Biologicals. 2017 Jul;48:55-65. doi: 10.1016/j.biologicals.2017.05.006. Epub 2017 Jun 7.
This article summarizes the outcome of an international workshop organized by the European Partnership for Alternative Approaches to Animal Testing (EPAA) on Modern science for better quality control of medicinal products: Towards global harmonization of 3Rs in biologicals. As regards the safety testing of biologicals, the workshop participants agreed to actively encourage the deletion of abnormal toxicity tests and target animal batch safety tests from all relevant legal requirements and guidance documents (country-specific guidelines, pharmacopoeia monographs, WHO recommendations). To facilitate the global regulatory acceptance of non-animal methods for the potency testing of, e.g., human diphtheria and tetanus vaccines and veterinary swine erysipelas vaccines, international convergence on the scientific principles of the use of appropriately validated in vitro assays for replacing in vivo methods was identified as an overarching goal. The establishment of scientific requirements for new assays was recognized as a further means to unify regulatory approaches in different jurisdictions. It was recommended to include key regulators and manufacturers early in the corresponding discussions. Manufacturers and responsible expert groups, e.g. at the European Directorate for the Quality of Medicines and Health Care of the Council of Europe or the European Medicines Agency, were invited to consider leadership for international collaboration.
本文总结了由欧洲替代动物试验方法合作组织（EPAA）举办的一场国际研讨会的成果，该研讨会主题为“用于提高药品质量控制的现代科学：实现生物制品3R原则的全球协调统一”。关于生物制品的安全性检测，研讨会参与者一致同意积极推动从所有相关法律要求和指导文件（各国特定指南、药典专论、世界卫生组织建议）中删除异常毒性试验和目标动物批次安全性试验。为促进全球监管机构接受非动物方法用于例如人用白喉和破伤风疫苗以及兽用猪丹毒疫苗的效力检测，确定了一个总体目标，即就使用经过适当验证的体外试验替代体内方法的科学原则达成国际共识。认识到为新试验制定科学要求是统一不同司法管辖区监管方法的又一途径。建议在相应讨论中尽早纳入主要监管机构和生产商。邀请生产商和负责的专家组，如欧洲药品质量管理局或欧洲药品管理局，考虑在国际合作中发挥引领作用。
