Assessment of genotoxicity of herbal substances/preparations - Scientific guideline
Table of contents
This document addresses the selection of materials for genotoxicity testing in support of applications for traditional herbal medicinal products/ herbal medicinal products.
Keywords: Herbal medicinal products, traditional herbal medicinal products, herbal substances, herbal preparations, extracts, genotoxicity testing
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Guideline on the assessment of genotoxicity of herbal substances/preparations (PDF/127.85 KB)
Adopted
First published: 21/05/2008
Last updated: 21/05/2008
Legal effective date: 01/12/2008
EMEA/HMPC/107079/2007 -
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Concept paper on the revision of the guideline on the assessment of genotoxicity of herbal substances/preparations (EMEA/HMPC/107079/2007) (PDF/190.94 KB)
Draft: consultation open
First published: 31/10/2022
Consultation dates: 31/10/2022 to 31/01/2023
EMA/HMPC/41456/2022
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Guideline on the assessment of genotoxicity of herbal substances/preparations (PDF/127.85 KB)
Adopted
First published: 21/05/2008
Last updated: 21/05/2008
Legal effective date: 01/12/2008
EMEA/HMPC/107079/2007 -
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Overview of comments received on draft guideline on the assessment of genotoxic constituents in herbal substances/ preparations (EMEA/HMPC/107079/2007) (PDF/169.13 KB)
First published: 21/05/2008
Last updated: 21/05/2008
EMEA/HMPC/232888/2008 -
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Draft guideline on the assessment of genotoxic constituents in herbal substances/preparations (PDF/140.42 KB)
Draft: consultation closed
First published: 31/10/2007
Last updated: 31/10/2007
EMEA/HMPC/107079/2007 -
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Concept paper on the development of a guideline on the assessment of genotoxic constituents in herbal substances/preparations (PDF/44.67 KB)
Draft: consultation closed
First published: 26/10/2006
Last updated: 26/10/2006
EMEA/HMPC/413271/2006