Non-clinical: Toxicology

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This page lists the European Medicines Agency's scientific guidelines in the area of non-clinical toxicology. 

If you have comments on a document which is open for consultation, please use the Form for submission of comments on scientific guidelines.

Table of contents

Single-Dose Toxicity

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Questions & answers on the withdrawal of the “Note for guidance on single dose toxicity”Questions and answersEMA/CHMP/SWP/81714/2010Jul 201024 Jun 2010 

Repeat-Dose Toxicity

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Repeated dose toxicity

Overview of comments

Adopted guideline

Draft guideline

CPMP/SWP/1042/99 Rev. 1 Corr.Mar 20101 Sep 2010Correction Nov 2010
Repeated dose toxicityAdopted guidelineCPMP/SWP/1042/99Jul 2000Oct 2000 
Duration of chronic toxicity testing in animals (rodent and non-rodent toxicity testing) (ICHS4A)Adopted guidelineCPMP/ICH/300/95Nov 1998May 1999 

Genotoxicity

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use (ICH S 2 (R1))Adopted guideline
Draft guideline
CHMP/ICH/126642/08Dec 2011June 2012 
Limits of genotoxic impuritiesAdopted guidelineCPMP/SWP/5199/02
CHMP/QWP/251344/2006
Jun 2006Jan 2007Questions and Answers on the guideline
Reflection Paper on the assessment of the Genotoxic Potential of Antisense OligodeoxynucleotidesAdopted guidelineCHMP/SWP/199726/04Jan 2005  
Position Paper on the genotoxic and carcinogenic potential of phenolphthaleinAdopted guidelineCPMP/818/97Dec 1997  
Genotoxicity: a standard battery for genotoxicity testing of pharmaceuticals (ICHS2B)Adopted guidelineCPMP/ICH/174/95Sep 1997Mar 1998 
Specific aspects of regulatory genotoxicity tests for pharmaceuticals (ICHS2A)Adopted guidelineCPMP/ICH/141/95Sep 1995Apr 1996 

Carcinogenicity

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Carcinogenicity Evaluation of Medicinal Products for the Treatment of HIV Infection

Overview of comments

Adopted guideline

Draft guideline

EMEA/194898/2006Dec 2007Jul 2008 
CHMP SWP Conclusions and recommendations on the use of genetically modified animal models for carcinogenicity assessmentAdopted guidelineCPMP/SWP/2592/02 Rev 1Jun 2004  
Carcinogenic potentialAdopted guidelineCPMP/SWP/2877/00Jul 2002Jan 2003 
Points to consider on the Non-clinical assessment of the carcinogenic potential of human insulin analoguesAdopted guidelineCPMP/SWP/372/01Nov 2001  
Carcinogenicity: testing for carcinogenicity of pharmaceuticals (ICH SIB)Adopted guidelineCPMP/ICH/299/95Sep 1997Mar 1998 
Need for carcinogenicity studies of pharmaceuticals (ICH SIA)Adopted guidelineCPMP/ICH/140/95Dec 1995Jul 1996 
Regulatory notice on changes to core guideline on rodent carcinogenicity testing of pharmaceuticals (ICH S1)Adopted guidelineCHMP/ICH/752486/2012Sept 2013Sept 2013 
Dose selection for carcinogenicity studies of pharmaceuticals (ICH S1 C (R2))Adopted guidelineCPMP/ICH/383/95Apr 2008Oct 2008 

Reproductive and Developmental Toxicity

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Risk Assessment of Medicinal Products on Human Reproduction and Lactation: From Data to Labelling

Adopted guideline

Draft guideline

EMEA/CHMP/203927/05Jul 2008Jan 2009 
Need for Non-Clinical Testing in Juvenile Animals on Human Pharmaceuticals for Paediatric Indications

Overview of comments

Adopted guideline

Draft guideline

CHMP/SWP/169215/05Jan 2008Aug 2008 
Points to consider on the Need for assessment of reproduction toxicity of human insulin analoguesAdopted guidelineCPMP/SWP/2600/01Mar 2002Mar 2002 
Reproductive toxicology: Detection of toxicity to reproduction for medicinal products including toxicity to male fertility (ICH S5A)Adopted guidelineCPMP/ICH/386/95 (ICH S5A)Sep 1993Mar 1994 

Local Tolerance

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues

Draft guideline

Concept paper

CHMP/SWP/187944/2014Released for consultation Apr 2014 Deadline for comments 31 Jul 2014
Non-clinical local tolerance testing of medicinal productsAdopted guidelineCPMP/SWP/2145/00Feb 2001Feb 2001 

Other Toxicity

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Questions and answers on the withdrawal of the guideline on pharmacokinetics and metabolic studies in the safety evaluation of new medicinal products in animals (3BS11A)

Adopted Q&A

 

EMEA/CHMP/SWP/1991104/2014May 2014 April 2014 
Guidance on photosafety evaluation of pharmaceuticals (ICH S10)

Adopted guideline

Draft guideline

CHMP/ICH/752211/2012January 2014 June 2014 
Non-clinical guideline on drug-induced hepatotoxicity

Adopted guideline

Draft guideline

CHMP/SWP/150115/06Jul 2010 24 Jun 2010 
Non-Clinical Investigation of the Dependence Potential of Medicinal ProductsAdopted guidelineCHMP/SWP/94227/04Mar 2006Sep 2006 
Immunotoxicity studies for Human Pharmaceuticals (ICH S8)Adopted guidelineCHMP/ICH/167235/04Oct 2005May 2006 
Need for revision of the Note for Guidance on photosafety testing

Adopted guideline

Concept paper

CPMP/SWP/398/01Release for consultation Jan 2008 Deadline for comments May 2008
Question & answers on the note for guidance on photosafety testing

Overview of comments

Adopted Q&A

Draft Q&A

EMA/CHMP/SWP/336670/2010Apr 201117 Mar 2011 
Background to the CPMP Position Paper on possible pre-clinical studies to investigate addiction and dependence/withdrawal related to the use of selective serotonin uptake inhibitors (SSRIs)Adopted guidelineCPMP/2278/00Dec 2000  
Background to the CPMP Position Paper on selective serotonin uptake inhibitors (SSRIs) and dependency/withdrawal reactionsAdopted guidelineEMEA/CPMP/2775/99Apr 2000  
Need for revision of the position on the replacement of animal studies by in vitro modelsConcept paperEMA/CHMP/SWP/169839/2011Release for consultation Mar 2011 Deadline for comments 17 June 2011
Replacement of animal studies by in vitro modelsAdopted guidelineCPMP/SWP/728/95Feb 1997  
In Vitro investigation of mitochondrial toxicity of anti-hiv nucleoside reverse transcriptase inhibitors

Draft guideline

Concept paper

CHMP/SWP/8212/07Release for consultation Dec 2007 Deadline for comments Jul 2008