New adjuvants: EU regulatory developments

被引：17

作者：

Sesordic, Dorothea

Rijpkemo, Sjoerd

Patel, Brijesh Prokosh

机构：

[1] Natl Inst Biol Stand & Controls, Div Bacteriol Blanche Lane, Potters Bar EN6 3QG, Herts, England

[2] Med & Healthcare Prod Regulatory Agcy, Biol Biotechnol Unit, London SW8 5NQ, England

来源：

EXPERT REVIEW OF VACCINES | 2007年 / 6卷 / 05期

关键词：

adjuvant; clinical evaluation; human vaccine; nonclinical safety evaluation; quality/pharmaceutical evaluation; regulatory development; regulatory requirements;

D O I：

10.1586/14760584.6.5.849

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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.

引用

页码：849 / 861

页数：13

共 40 条

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