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

Current effective version

Guideline on non-clinical local tolerance testing of medicinal products

Adopted Reference Number: EMA/CHMP/SWP/2145/2000 Rev. 1 Corr. Summary:

This document provides guidance for 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.

Document history - Revision 1 (current)

Guideline on non-clinical local tolerance testing of medicinal products

Adopted Reference Number: EMA/CHMP/SWP/2145/2000 Rev. 1 Corr. Summary:

This document provides guidance for 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.

Overview of comments received on 'Draft guideline on non-clinical local tolerance testing of medicinal products’

Reference Number: EMA/699381/2000

Draft guideline on non-clinical local tolerance testing of medicinal products

Draft: consultation closed Consultation dates: 30/04/2014 to 31/07/2014 Reference Number: EMA/CHMP/SWP/2145/2000 Rev. 1 Summary:

Local tolerance testing is intended to support human exposure to a medicinal product (both active substance and excipient) at contact sites of the body following clinical use.

Concept paper on the need for revision of the guideline on non-clinical local tolerance testing of medicinal products

Draft: consultation closed Consultation dates: 21/07/2011 to 30/10/2011 Reference Number: EMA/CHMP/SWP/708666/2010 Summary:

Over the past years, newer routes of administration, e.g. transdermal systems, are being used more frequently and a shift has been observed towards the regulatory acceptance of scientifically valid in vitro methods as well as formally validated in vitro methods as part of an integrated testing strategy.

Document history - First version

Note for guidance on non-clinical local tolerance testing of medicinal products

Adopted Reference Number: CPMP/SWP/2145/00 Legal effective date: 01/02/2001