Non-clinical guidelines
European Union guidelines adopted in Australia
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AGRD refers to: Australian Guidelines for the Registration of Drugs, Volume I, second edition, July 1994 (Australian Government Publishing Service). Superseded by the Australian Regulatory Guidelines for Prescription Medicines (ARGPM)
ARGPM refers to: Australian Regulatory Guidelines for Prescription Medicines, June 2004. Published on the Therapeutic Goods Administration (TGA) Internet site
Rules 2001 (Vol. 9) refers to: EU Pharmacovigilance Rules for Human and Veterinary Medicinal Products - EudraLex Volume 9 - December 2001
Rules 1989 refers to: The Rules Governing Medicinal Products in the European Community Volume III 1989 - Guidelines on the quality safety and efficacy of medicinal products for human use
Rules Addendum refers to: The Rules Governing Medicinal Products in the European Community Volume III Addendum July 1990 - Guidelines on the quality safety and efficacy of medicinal products for human use
Rules 1998 (3A) refers to: The Rules Governing Medicinal Products in the European Union - EudraLex - Medicinal products for human use, 1998 Edition: Volume 3A - Quality and Biotechnology
Rules 1998 (3B) refers to: The Rules Governing Medicinal Products in the European Union - EudraLex - Medicinal products for human use, 1998 Edition: Volume 3B - Safety and the Environment
Rules 1998 (3C) refers to: The Rules Governing Medicinal Products in the European Union - EudraLex - Medicinal products for human use, 1998 Edition: Volume 3C - Efficacy and information on the medicinal product
Rules 1997 (4) refers to: The Rules Governing Medicinal Products in the European Union - EudraLex - Medicinal products for human and veterinary use, 1997 Edition: Volume 4 - Pharmaceutical Legislation - Good Manufacturing Practices
General guidelines
CPMP/BWP/3088/99 (pdf,128kb)
Note for Guidance on the Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products
Published: TGA Internet Site
Effective: 7 May 2003
Adopted by the TGA with the following notation:
Sponsors are advised that consultation with the Office of the Gene Technology Regulator (OGTR) is required for applications covered by this guideline, as is described in Section 30C of the Therapeutic Goods Act.
CPMP/ICH/302/95 (pdf,85kb)
Note for Guidance on Preclinical Safety Evaluation of Biotechnology Derived Pharmaceuticals
Published: TGA News September 1999
Effective: 1 October 1999
CPMP/SWP/465/95 (pdf,46kb)
Note for Guidance on Pre-Clinical Pharmacological and Toxicological Testing of Vaccines
Published: TGA News April 2000
Effective: 1 May 2000
CPMP/SWP/799/95 (pdf,39kb)
Guideline on the Non-Clinical Documentation for Mixed Marketing Authorisation Applications
Published: TGA Internet site
Effective: April 2006
CPMP/SWP/997/96 (pdf,36kb)
Note for Guidance on the Pre-clinical Evaluation of Anticancer Medicinal Products
Published: TGA News April 2000
Effective: 1 May 2000
CPMP/SWP/1094/04 (pdf,35kb)
Guideline on the Evaluation of Control Samples in Nonclinical Safety Studies: Checking for Contamination with the Test Substance
Published: TGA Internet site
Effective: 1 September 2005
CPMP/SWP/2599/02, rev 1 (pdf,193kb)
Position Paper on Non-Clinical Safety Studies to Support Clinical Trials with a Single Microdose
Published: TGA Internet site
Effective: 2 May 2005
Adopted by the TGA with the following notation:
It is strongly recommended that Sponsors discuss the appropriateness of their non-clinical safety program (supporting single microdose clinical trials) with TGA prior to submission in order to clarify data expectations.
EMEA/CHMP/SWP/258498/2005 (pdf,44kb)
Guideline on the Non-Clinical Development of Fixed Combinations of Medicinal Products
Published: TGA Internet site
Effective: 23 October 2008
EMEA/CPMP/3097/02 (pdf,230kb)
Guideline on Comparability of Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues
Published: TGA Internet site
Effective: 12 May 2005
Adopted by the TGA with the following notation:
Sponsors should seek pre-submission meetings in order to clarify the information required by the TGA in this regard.
Similar biological medicinal products
CHMP/437/04 (pdf,109kb)
Guideline on Similar Biological Medicinal Products
Published: TGA Internet site
Effective: 15 June 2006
EMEA/CHMP/BMWP/42832/2005 (pdf,105kb)
Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substances: Non-Clinical and Clinical Issues
Published: TGA Internet site
Effective: 29 September 2006
EMEA/CHMP/BMWP/94526/2005 corr (pdf,46kb)
Annex Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues - Guidance on Biosimilar Medicinal Products Containing Recombinant Erythropoietins
Published: TGA Internet site
Effective: 29 September 2006
EMEA/CHMP/32775/2005 (pdf,98kb)
Annex Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues. Guidance on Similar Medicinal Products Containing Recombinant Human Insulin
Published: TGA Internet site
Effective: 12 September 2006
EMEA/CHMP/BMWP/31329/2005 (pdf,92kb)
Annex Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues - Guidance on Biosimilar Medicinal Products Containing Recombinant Granulocyte-Colony Stimulating Factor
Published: TGA Internet site
Effective: 29 September 2006
EMEA/CHMP/BMWP/94528/2005 (pdf,75kb)
Annex Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance:Non-Clinical and Clinical Issues. Guidance on Similar Medicinal Products Containing Somatropin
Published: TGA Internet site
Effective: 29 September 2006
Pharmacokinetics guidelines
pp. 21 - 24 of Rules 1998 (3B) - 3BS3a (pdf,17kb)
Repeated Dose Tissue Distribution Studies
Replaces: CPMP/ICH/385/95 (Adopted by TGA as III/5082/94 April 1996)
Effective: 12 February 2002
pp. 89 - 101 of Rules 1998 (3B) - 3BS10a (pdf,49kb)
The Assessment of Systemic Exposure in Toxicity Studies
Replaces: CPMP/ICH/384/95 (Adopted by TGA as III/5081/94 April 1996)
Effective: 12 February 2002
pp. 103 - 106 of Rules 1998 (3B) - 3BS11a (pdf,17kb)
Pharmacokinetics and Metabolic Studies in the Safety Evaluation of New Medicinal Products in Animals
Replaces: pp. 113 - 114 of Rules 1989
Effective: 12 February 2002
Pharmacology guidelines
CHMP/ICH/423/02 (pdf,96kb)
Note for guidance on the Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT interval prolongation) by Human Pharmaceuticals
Published: TGA Internet site
Effective: 4 January 2006
CPMP/ICH/539/00 (pdf,81kb)
Note for Guidance on Safety Pharmacology Studies for Human Pharmaceuticals
Published: TGA Internet site
Effective: 10 January 2002
Toxicology guidelines
pp. 3 - 8 of Rules 1998 (3B) - 3BS1a (pdf,18kb)
Single Dose Toxicity
Replaces: pp. 89 - 90 of Rules 1989
Effective: 12 February 2002
pp. 25 - 44 of Rules 1998 (3B) - 3BS4a (pdf,71kb)
Detection of Toxicity to Reproduction for Medicinal Products including Toxicity to Male Fertility
Replaces: CPMP/ICH/386/95 (Adopted as III/3387/93 by TGA 1/1/1995), CPMP/ICH/136/95 Mod (Adopted by TGA 19 April 2001) and pp. 99 - 101 of Rules 1989
Effective: 12 February 2002
pp. 45 - 50 of Rules 1998 (3B) - 3BS5a (pdf,23kb)
Testing of Medicinal Products for Their Mutagenic Potential
Replaces: pp. 103 - 105 of Rules 1989
Effective: 12 February 2002
See also: CPMP/ICH/174/95 (Adopted by TGA December 1998) and pp. 51 - 62 of Rules 1998 (3B) - 3BS6a
pp. 51 - 62 of Rules 1998 (3B) - 3BS6a (pdf,49kb)
Genotoxicity: Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals
Replaces: CPMP/ICH/141/95 (Adopted by TGA 1 October 1999)
Effective: 12 February 2002
pp. 73 - 78 of Rules 1998 (3B) - 3BS8a (pdf,27kb)
The Need for Carcinogenicity Studies of Pharmaceuticals
Replaces: CPMP/ICH/140/95 (Adopted by TGA December 1998)
Effective: 7 April 2003
CHMP/ICH/383/1995 (pdf,94kb)
Note for Guidance on Dose Selection for Carcinogenicity Studies of Pharmaceuticals
Published: TGA Internet site
Effective 23 October 2008
CPMP/ICH/174/95 (pdf,74kb)
Note for Guidance on Genotoxicity: a Standard Battery for Genotoxicity Testing of Pharmaceuticals
Published: TGA News December 1998
Effective: December 1998
CPMP/ICH/286/95 Mod (pdf,70kb)
Note for Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals
Published: TGA Internet site
Effective: 19 April 2001
CPMP/ICH/299/95 (pdf,68kb)
Note for Guidance on Carcinogenicity: Testing for Carcinogenicity of Pharmaceuticals
Published: TGA News April 2000
Effective: 1 May 2000
CPMP/ICH/300/95 (pdf,210kb)
Note for Guidance on Duration of Chronic Toxicity Testing in Animals (Rodent and Non-rodent Toxicity Testing)
Published: TGA Internet site with amendment
Effective: 30 August 2001
See also: CPMP/SWP/1042/99 (Adopted by TGA 23 February 2001)
Adopted by the TGA with the following notation:
It should be noted that while the ICH guidance recommends 9-month chronic toxicity studies in non-rodents, the TGA considers 9-month studies in non-rodents acceptable for most drug development programs, shorter studies may be equally acceptable in some circumstances and longer studies may be more appropriate in others, as follows:
- Six-month studies may be acceptable for indications of chronic conditions associated with short-term, intermittent drug exposure, such as bacterial infections, migraine, erectile dysfunction, and herpes.
- Six-month studies may be acceptable for drugs intended for indications for life-threatening diseases for which substantial long-term human clinical data are available, such as cancer chemotherapy in advanced disease or in adjuvant use.
- Twelve-month studies may be more appropriate for chronically used drugs to be approved on the basis of short-term clinical trials employing efficacy surrogate markers where safety data from humans are limited to short-term exposure, such as some acquired immunodeficiency syndrome (AIDS) therapies.
- Twelve-month studies may be more appropriate for new molecular entities acting at new molecular targets where post-marketing experience is not available for the pharmacological class. Thus, the therapeutic is the first in a pharmacological class for which there is limited human or animal experience on its long-term toxic potential.
CPMP/SWP/372/01 (pdf,158kb)
Points to Consider on the Non-Clinical Assessment of the Carcinogenic Potential of Insulin Analogues
Published: TGA Internet site
Effective: 4 September 2002
CPMP/SWP/398/01 (pdf,195kb)
Note for Guidance on Photosafety Testing
Published: TGA Internet site
Effective: 17 September 2004
CPMP/SWP/1042/99 (pdf,87kb)
Note for Guidance on Repeated Dose Toxicity
Published: TGA Internet Site
Effective: 23 February 2001
See also: CPMP/ICH/300/95 (Adopted by TGA 30 August 2001 - with amendment)
CPMP/SWP/2145/00 (pdf,295kb)
Note for Guidance on Non-Clinical Local Tolerance Testing of Medicinal Products
Replaces:III/3979/88 (Adopted by TGA July 1994) and pp. 107-116 of rules 1998 (3B) - 3BS12a
Published: TGA Internet site
Effective: 10 January 2002
Adopted by the TGA with the following notation:
"Ocular tolerance testing using the Draize method is not permitted in some states of Australia. The use of alternative methods should be discussed with the TGA."
CPMP/SWP/2600/01 (pdf,154kb)
Points to Consider on the Need for Assessment of Reproductive Toxicity of Human Insulin Analogues
Published: TGA Internet site
Effective: 5 March 2003
CPMP/SWP/2877/00 (pdf,158kb)
Note for Guidance on Carcinogenic Potential
Published: TGA Internet site
Effective: 5 March 2003
CPMP/SWP/5199/02 (pdf, 54kb)
Guideline on the Limits of Genotoxic Impurities
Published: TGA Internet site
Effective: November 2006
EMEA/CHMP/167235/2004 (pdf,96kb)
Note for Guidance on Immunotoxicity Studies for Human Pharmaceuticals
Published: TGA Internet site
Effective: April 2006
The European Agency for the Evaluation of Medicinal Products (EMEA)