Non-clinical local tolerance testing of medicinal products - Scientific guideline
This document provides guidance on the non-clinical local tolerance testing of medicinal products for human use. It addresses the development and evaluation of medicinal products that will, or have the potential to, come into contact with different sites of the human body following normal clinical use, as well as after unintentional administration.
Keywords: Non-clinical, local tolerance testing, toxicity studies, sensitising potential, oral, ocular, cutaneous, transdermal, parenteral, rectal, vaginal
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Guideline on non-clinical local tolerance testing of medicinal products (PDF/128.18 KB)
Adopted
First published: 27/11/2015
Last updated: 27/11/2015
EMA/CHMP/SWP/2145/2000 Rev. 1 Corr. -
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Overview of comments received on 'Draft guideline on non-clinical local tolerance testing of medicinal products’ (PDF/341.33 KB)
First published: 27/11/2015
Last updated: 27/11/2015
EMA/699381/2000 -
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Draft guideline on non-clinical local tolerance testing of medicinal products (PDF/295.75 KB)
Draft: consultation closed
First published: 30/04/2014
Last updated: 30/04/2014
Consultation dates: 30/04/2014 to 31/07/2014
EMA/CHMP/SWP/2145/2000 Rev. 1 -
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Concept paper on the need for revision of the guideline on non-clinical local tolerance testing of medicinal products (PDF/73.91 KB)
Draft: consultation closed
First published: 26/07/2011
Last updated: 26/07/2011
Consultation dates: 21/07/2011 to 30/10/2011
EMA/CHMP/SWP/708666/2010