New adjuvants: EU regulatory developments.
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.
Sesardic
Dorothea
D
National Institute for Biological Standards and Control, Division of Bacteriology, Blanche Lane, South Mimms, Potters Bar, Hertfordshire, EN6 3QG, UK. dsesardic@nibsc.ac.uk
Rijpkema
Sjoerd
S
Patel
Brijesh Prakash
BP
D000276:Adjuvants, Immunologic; D000277:Adjuvants, Pharmaceutic; D000818:Animals; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000379:methods; D005062:European Union; D006801:Humans
D000276:Adjuvants, Immunologic; D000277:Adjuvants, Pharmaceutic