Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report.

加速全球删除疫苗和生物制品的异常毒性测试。规划共同的后续步骤。工作坊报告。

• 影响指数: 1.76
• 发表时间: Jul 2022
• 来源期刊: Biologicals
• DOI: 10.1016/j.biologicals.2022.06.003
• PMID: 35840492
• 文章类型: Journal Article
• 中科院分区: Q4
• 方向: 生物
• 作者列表: Viviani L,Reid K,Gastineau T,Milne C,Smith D,Levis R,Lei D,van Ooij M,Gilbert PA,Vandeputte J,Xie J,Madhuri L,Shaid S,Kubiak V,Suri R,Mizukami T,Shirasaki Y,Li X,Zhou YY,Trapkova A,Goel S,Prakash J,Subagio AA,Suwarni E,Jung KJ,Sanyal G,Das P,Coppens E,Wright D,Peng Z,Northeved H,Jungbäck C,Kirpitchenok T,Del Pace L,Seo B,Poojary B,Ottoni A

关键词: Abnormal toxicity test; Batch release testing; Batch safety test; Public health; Vaccines

Mesh: Drug Industry; Humans; Reference Standards; Toxicity Tests; Vaccines / adverse effects

Abstract

This online workshop Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps was organized on October 14th, 2021, by the Animal Free Safety Assessment Collaboration (AFSA), the Humane Society International (HSI), the European Federation of Pharmaceutical Industries and Associations (EFPIA), in collaboration with the International Alliance of Biological Standardization (IABS). The workshop saw a participation of over a hundred representatives from international organizations, pharmaceutical industries and associations, and regulatory authorities of 28 countries. Participants reported on country- and region-specific regulatory requirements and, where present, on the perspectives on the waiving and elimination of the Abnormal Toxicity Test. With AFSA, HSI, EFPIA and IABS representatives as facilitators, the participants also discussed specific country/global actions to further secure the deletion of ATT from all regulatory requirements worldwide.

摘要

该在线研讨会加速全球删除疫苗和生物制品的异常毒性测试。10月14日组织了共同的下一步计划，2021年，由动物自由安全评估合作组织（AFSA）国际人道协会(HSI)欧洲制药工业协会联合会（EFPIA），与国际生物标准化联盟（IABS）合作。来自国际组织的一百多名代表参加了讲习班，制药行业和协会，和28个国家的监管机构。与会者报告了具体国家和区域的监管要求，存在的地方，关于放弃和消除异常毒性试验的观点。有了AFSA,HSI,EFPIA和IABS代表作为主持人，与会者还讨论了具体的国家/全球行动，以进一步确保从全球所有监管要求中删除ATT。