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Table of contents
Single-Dose Toxicity
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| Topic | Documents | Reference number | Publication date | Effective date | Remarks |
|---|
| Questions & answers on the withdrawal of the “Note for guidance on single dose toxicity” | Questions and answers | EMA/CHMP/SWP/81714/2010 | Jul 2010 | 24 Jun 2010 | |
Repeat-Dose Toxicity
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Genotoxicity
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| Topic | Documents | Reference number | Publication date | Effective date | Remarks |
|---|
| Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals intended for Human use (ICH S 2 (R1)) | Draft guideline | CHMP/ICH/126642/08 | Release for consultation Mar 2008 | | Deadline for comments May 2008 |
| Limits of genotoxic impurities | Adopted guideline | CPMP/SWP/5199/02
CHMP/QWP/251344/2006 | Jun 2006 | Jan 2007 | Questions and Answers on the guideline |
| Reflection Paper on the assessment of the Genotoxic Potential of Antisense Oligodeoxynucleotides | Adopted guideline | CHMP/SWP/199726/04 | Jan 2005 | | |
| Position Paper on the genotoxic and carcinogenic potential of phenolphthalein | Adopted guideline | CPMP/818/97 | Dec 1997 | | |
| Genotoxicity: a standard battery for genotoxicity testing of pharmaceuticals (ICHS2B) | Adopted guideline | CPMP/ICH/174/95 | Sep 1997 | Mar 1998 | |
| Specific aspects of regulatory genotoxicity tests for pharmaceuticals (ICHS2A) | Adopted guideline | CPMP/ICH/141/95 | Sep 1995 | Apr 1996 | |
Carcinogenicity
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| Topic | Documents | Reference number | Publication date | Effective date | Remarks |
|---|
| Carcinogenicity Evaluation of Medicinal Products for the Treatment of HIV Infection | Overview of comments Adopted guideline Draft guideline | EMEA/194898/2006 | Dec 2007 | Jul 2008 | |
| CHMP SWP Conclusions and recommendations on the use of genetically modified animal models for carcinogenicity assessment | Adopted guideline | CPMP/SWP/2592/02 Rev 1 | Jun 2004 | | |
| Carcinogenic potential | Adopted guideline | CPMP/SWP/2877/00 | Jul 2002 | Jan 2003 | |
| Points to consider on the Non-clinical assessment of the carcinogenic potential of human insulin analogues | Adopted guideline | CPMP/SWP/372/01 | Nov 2001 | | |
| Carcinogenicity: testing for carcinogenicity of pharmaceuticals (ICH SIB) | Adopted guideline | CPMP/ICH/299/95 | Sep 1997 | Mar 1998 | |
| Need for carcinogenicity studies of pharmaceuticals (ICH SIA) | Adopted guideline | CPMP/ICH/140/95 | Dec 1995 | Jul 1996 | |
| Dose selection for carcinogenicity studies of pharmaceuticals (ICH S1 C (R2)) | Adopted guideline | CPMP/ICH/383/95 | Apr 2008 | Oct 2008 | |
Reproductive and Developmental Toxicity
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| Topic | Documents | Reference number | Publication date | Effective date | Remarks |
|---|
| Risk Assessment of Medicinal Products on Human Reproduction and Lactation: From Data to Labelling | Adopted guideline Draft guideline | EMEA/CHMP/203927/05 | Jul 2008 | Jan 2009 | |
| Need for Non-Clinical Testing in Juvenile Animals on Human Pharmaceuticals for Paediatric Indications | Overview of comments Adopted guideline Draft guideline | CHMP/SWP/169215/05 | Jan 2008 | Aug 2008 | |
| Points to consider on the Need for assessment of reproduction toxicity of human insulin analogues | Adopted guideline | CPMP/SWP/2600/01 | Mar 2002 | Mar 2002 | |
| Reproductive toxicology: Detection of toxicity to reproduction for medicinal products including toxicity to male fertility (ICH S5A) | Adopted guideline | CPMP/ICH/386/95 (ICH S5A) | Sep 1993 | Mar 1994 | |
Local Tolerance
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| Topic | Documents | Reference number | Publication date | Effective date | Remarks |
|---|
| Need for revision of the guideline non-clinical local tolerance testing of medicinal products | Concept paper | EMA/CHMP/SWP/708666/2010 | Released for consultation Jul 2011 | | Deadline for comments 30 Oct 2011 |
| Non-clinical local tolerance testing of medicinal products | Adopted guideline | CPMP/SWP/2145/00 | Feb 2001 | Feb 2001 | |
Other Toxicity
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| Topic | Documents | Reference number | Publication date | Effective date | Remarks |
|---|
| Non-clinical guideline on drug-induced hepatotoxicity | Adopted guideline Draft guideline | CHMP/SWP/150115/06 | Jul 2010 | 24 Jun 2010 | |
| Non-Clinical Investigation of the Dependence Potential of Medicinal Products | Adopted guideline | CHMP/SWP/94227/04 | Mar 2006 | Sep 2006 | |
| Immunotoxicity studies for Human Pharmaceuticals (ICH S8) | Adopted guideline | CHMP/ICH/167235/04 | Oct 2005 | May 2006 | |
| Need for revision of the Note for Guidance on photosafety testing | Adopted guideline Concept paper | CPMP/SWP/398/01 | Release 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/336670/2010 | Apr 2011 | 17 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 guideline | CPMP/2278/00 | Dec 2000 | | |
| Background to the CPMP Position Paper on selective serotonin uptake inhibitors (SSRIs) and dependency/withdrawal reactions | Adopted guideline | EMEA/CPMP/2775/99 | Apr 2000 | | |
| Need for revision of the position on the replacement of animal studies by in vitro models | Concept paper | EMA/CHMP/SWP/169839/2011 | Release for consultation Mar 2011 | | Deadline for comments 17 June 2011 |
| Replacement of animal studies by in vitro models | Adopted guideline | CPMP/SWP/728/95 | Feb 1997 | | |
| In Vitro investigation of mitochondrial toxicity of anti-hiv nucleoside reverse transcriptase inhibitors | Draft guideline Concept paper | CHMP/SWP/8212/07 | Release for consultation Dec 2007 | | Deadline for comments Jul 2008 |
