Regulatory issues regarding manufacture and control of vaccine adjuvants. The EU situation.

Last updated on 23-8-2019 by Anonymous (niet gecontroleerd)

Scientific poster, presentation or proceeding




Adjuvants are a specific group of vaccine/medicinal product compounds, since they are not classified as active substance but have more than just a stabilising activity. According to the EMA guideline EMEA/CHMP/QWP/39695½006 (Guideline on excipients in the dossier for marketing authorization of a medicinal product), adjuvants, being no active substance, are categorised as excipients like antioxidants, preservatives, stabilisers, and many other. In the EMA guideline EMEA/CHMP/VEG/134716/2004 (Guideline on adjuvants in vaccines for human use) adjuvants are described as components that potent…

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