Adjuvants in vaccines for human use - Scientific guideline
Table of contents
This document addresses the quality issues arising from the use of new or established adjuvants in vaccines. The applicability of this guideline to established adjuvants will vary on case-by-case basis. Adjuvants that are given separately and/or at a different time point from the vaccine antigens are not considered to be adjuvants and are called immunomodulators. Read together with the
Explanatory note on immunomodulators
EMA will not update this guideline as its clinical and non-clinical sections have been superseded by the:
Applicants can still use the quality section of this guideline, as it remains valid. |
Keywords: Immunomodulators, adjuvants, vaccines
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Guideline on adjuvants in vaccines for human use (see also explanatory note) (PDF/384.82 KB)
Adopted
First published: 20/01/2005
Last updated: 16/02/2023
Legal effective date: 31/07/2005
EMEA/CHMP/VEG/134716/2004 -
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Concept paper on the development of a committee for proprietary medicinal products (CPMP) note for guidance on requirements for the evaluation of new adjuvants in vaccines (PDF/122.19 KB)
First published: 25/04/2002
Last updated: 25/04/2002
CPMP/BWP/6622/02 -
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Draft guideline on adjuvants in vaccines (PDF/205.95 KB)
First published: 25/03/2004
Last updated: 25/03/2004
Legal effective date: 25/03/2004
EMEA/CPMP/VEG/17/03/2004v 5/Consultation
- Biologicals: active substance
- Multidisciplinary: vaccines
Explanatory note on immunomodulators- Clinical evaluation of new vaccines - Scientific guideline
- ICH Q5A (R1) Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
- ICH Q5B Analysis of the expression construct in cell lines used for production of rDNA-derived protein products
- ICH Q5D Derivation and characterisation of cell substrates used for production of biotechnological/biological products
- ICH M3 (R2) Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals
- ICH S2 (R1) Genotoxicity testing and data interpretation for pharmaceuticals intended for human use
- ICH S5 (R2) Reproductive toxicology: detection of toxicity to reproduction for medicinal products including toxicity to male fertility
- ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals
- Pharmaceutical and biological aspects of combined vaccines
- Quality, preclinical and clinical aspects of gene therapy medicinal products