New adjuvants: EU regulatory developments

作者：Sesordic Dorothea^*; Rijpkemo Sjoerd; Patel Brijesh Prokosh

来源：Expert Review of Vaccines, 2007, 6(5): 849-861.

DOI：10.1586/14760584.6.5.849

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

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.

• 出版日期2007-10