新型佐剂：欧盟监管进展

New adjuvants: EU regulatory developments.

作者信息

Sesardic Dorothea, Rijpkema Sjoerd, Patel Brijesh Prakash

机构信息

National Institute for Biological Standards and Control, Division of Bacteriology, Blanche Lane, South Mimms, Potters Bar, Hertfordshire, EN6 3QG, UK.

出版信息

Expert Rev Vaccines. 2007 Oct;6(5):849-61. doi: 10.1586/14760584.6.5.849.

DOI:10.1586/14760584.6.5.849

PMID:17931163

Abstract

This paper discusses EU regulatory texts that are relevant for the introduction of new adjuvants in human vaccines and discusses the EU requirements at the developmental level, during the manufacturing process and at the final product stage. The emphasis is on regulatory expectations regarding safety at preclinical and clinical stages. The article highlights regulatory concerns and existing bottlenecks that have led to a slow approval process for new adjuvants.

摘要

本文讨论了与在人类疫苗中引入新佐剂相关的欧盟监管文本，并探讨了欧盟在研发阶段、生产过程和最终产品阶段的要求。重点是临床前和临床阶段关于安全性的监管期望。本文还强调了导致新佐剂审批过程缓慢的监管问题和现有瓶颈。