基于菌体的兽医产品:调整监管框架和市场整合的发展挑战
Céline Antoine1, David Mackay2, Paul Midtlyng3
1Laboratory of Veterinary Bacteriology, Department of Infectious and Parasitic Diseases, FARAH Research Center, Faculty of Veterinary Medicine, University of Liège, 4000, Liège, Belgium.
概括
菌体在兽医中为抗生素提供了一个有希望的替代品,原因是抗菌素耐药性日益增加. 然而,必须克服监管和商业障碍,将菌体治疗纳入常规兽医实践.
科学领域:
- 兽医医学 兽医医学 兽医医学
- 微生物学 微生物学
- 生物技术是生物技术.
背景情况:
- 抗菌素耐药性 (AMR) 需要在兽医中使用替代治疗方法.
- 菌体 (菌体) 是感染细菌的病毒,正在被重新考虑作为抗生素的补充疗法.
研究的目的:
- 讨论开发和销售用于兽医用途的菌体产品所面临的科学,监管和商业挑战.
- 确定法规协调和菌体治疗的市场准入的途径.
主要方法:
- 内容基于IABS研讨会"避免抗菌素耐药性:用于预防,治疗和控制细菌感染的菌体的兽医使用"的讨论.
- 考虑了专家意见和当前的监管格局.
主要成果:
- 基于菌体的产品因其生物性质而面临独特的挑战,需要创新的产品开发和监管方法.
- 目前的监管途径 (兽医药品,主管制剂,食品添加剂,生物杀菌剂) 对于菌体来说并不理想.
- 最近的指导方针提供了一些灵活性,但制造成本和监管可行性仍然令人担忧.
结论:
- 监管协调至关重要,以促进基于菌体的兽医产品进入市场.
- 克服监管和财务障碍对于将菌体治疗纳入兽医学以控制细菌感染至关重要.
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