New adjuvants: EU regulatory developments

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.

Keywords::

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

Acknowledgements

The content of this article reflects the personal views and conclusions of the authors and should not be interpreted as representing the position of the MHRA, EMEA , CHMP or NIBSC.

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.