Abstract:
Humane Society International India (HSI India) organized and facilitated a workshop on the \'Future of Target Animal Batch Safety Test (TABST) and Laboratory Animal Batch Safety Test (LABST) in the Indian Pharmacopoeia (IP) Monographs\'. The workshop hosted key Indian regulators from the Indian Pharmacopoeia Commission (IPC) and the Central Drugs Standard Control Organization (CDSCO), industry representatives from the Indian Federation of Animal Health Companies (INFAH), Asian Animal Health Association (AAHA), and international experts representing the European Directorate for the Quality of Medicines (EDQM), the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), and multinational veterinary products manufacturers. The workshop was organized to encourage a bidirectional flow of information and to discuss the deletion of TABST and LABST from the veterinary vaccine monographs in the IP. This workshop was built from the symposium held by Humane Society International on the \'Global Harmonization of Vaccine Testing Requirements\' held in 2019. This report details the outcomes of the workshop with proposed activities to be taken up as part of the next steps for the elimination or waiving of these tests.
摘要:
国际印度人道协会(HSIIndia)组织并推动了“印度药典(IP)专著中目标动物批次安全性测试(TABST)和实验动物批次安全性测试(LABST)的未来”研讨会。研讨会接待了印度药典委员会(IPC)和中央药物标准控制组织(CDSCO)的主要印度监管机构,印度动物保健公司联合会(INFAH)的行业代表,亚洲动物健康协会(AAHA)以及代表欧洲药品质量局(EDQM)的国际专家,关于协调兽药注册技术要求的国际合作(VICH),和跨国兽医产品制造商。举办研讨会是为了鼓励信息的双向流动,并讨论从知识产权中的兽医疫苗专著中删除TABST和LABST。该研讨会是由国际人道协会于2019年举行的“全球疫苗测试要求协调”研讨会建立的。本报告详细介绍了研讨会的成果,并提议开展活动,作为消除或放弃这些测试的后续步骤的一部分。