European Union guidelines
EU guidelines
- EU guidelines - ADOPTED in Australia
- EU guidelines - NOT adopted in Australia
- EU guidelines - REPLACED or SUPERSEDED (previously published as adopted)
Related information
EU guidelines - newly published
The following guidelines have been published in the last 4 months.
Guidelines adopted in the last 4 months
- EMEA/CHMP/PEG/194810/2005
Reflection Paper: Formulations of Choice for the Paediatric Population
Published: TGA Internet site
Effective: 29 June 2009 - EMEA/CHMP/EWP/311890/2007
Guideline on the Evaluation of Medicinal Products for Cardiovascular Disease Prevention
Published: TGA Internet site
Effective: 29 June 2009 - EMEA/CHMP/BWP/398498/2005
Guideline on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products
Published: TGA Internet site
Effective: 29 June 2009 - EMEA/CHMP/BWP/304831/2007
Guideline on Allergen Products: Production and Quality Issues
Published: TGA Internet site
Effective: 29 June 2009 - EMEA/CHMP/BWP/271475/2006
Guideline on Potency Testing of Cell Based Immunotherapy Medicinal Products for the Treatment of Cancer
Published: TGA Internet site
Effective: 29 June 2009 - EMEA/CHMP/PGxWP/201914/2006
Reflection Paper on Pharmacogenomic Samples, Testing and Data Handling
Published: TGA Internet site
Effective: 29 June 2009 - CPMP/QWP/1719/00 Rev 1
Guideline on Medicinal Gases: Pharmaceutical Documentation (Including Recommendation on Non-Clinical Safety Requirements for Well Established Medicinal Gases)
Published: TGA Internet site
Effective: 26 June 2009 - CPMP/EWP/422/04
Guideline on Clinical Investigation of Medicinal Products for the Treatment of Juvenile Idiopathic Arthritis
Published: TGA Internet site
Effective: 26 June 2009 - CHMP/SWP/28367/2007
Guideline on Strategies to Identify and Mitigate Risks for First-In-Human Clinical Trials with Investigational Medicinal Products
Published: TGA Internet site
Effective: 26 June 2009 - EMEA/CHMP/BWP/481473/2008
Concept Paper on the Need to Update the Current Annex Guideline on Cell Culture Inactivated Influenza Vaccines With Respect to the Derivation of Cell-Isolated Influenza Vaccine Viruses
Published: TGA Internet site
Effective: 26 June 2009 - EMEA/CHMP/BMWP/14327/2006
Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins
Published: TGA Internet site
Effective: 22 June 2009 - EMEA/CHMP/203927/2005
Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: From Data to Labelling
Published: TGA Internet site
Effective: 22 June 2009 - EMEA/CHMP/QWP/306970/2007
Guideline for Radiopharmaceuticals
Published: TGA Internet site
Effective: 22 June 2009 - EMEA/CHMP/EWP/435635/2008
Concept Paper on the Need for Revision of the Note for Guidance on Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections (CPMP/EWP/558/95 Rev 1)
Published: TGA Internet site
Effective: 1 May 2009 - EMEA/CHMP/EWP/8197/2009
Concept Paper on the Need for Revision of the Points to Consider on Clinical Investigation of Medicinal Products in the Chronic Treatment of Patients with Chronic Obstructive Pulmonary Disease (COPD) (CPMP/EWP/562/98)
Published: TGA Internet site
Effective: 1 May 2009 - EMEA/CHMP/SWP/4446/2000
Guideline on the Specification Limits for Residues of Metal Catalysts or Metal Reagents
Published: TGA Internet site
Effective: 1 May 2009 - EMEA/CHMP/EWP/644261/2008
Concept Paper on the Need for the Development of a Paediatric Addendum to the CHMP Guideline on the Clinical Investigations of Medicinal Products for the Treatment of Pulmonary Arterial Hypertension
Published: TGA Internet site
Effective: 1 May 2009 - EMEA/CHMP/EWP/545456/2008
Concept Paper on the Need for the Development of a Paediatric Addendum to the Note for Guidance on the Clinical Investigation on Medicinal Products in the Treatment of Hypertension
Published: TGA Internet site
Effective: 1 May 2009 - EMEA/273974/2005
Guideline on Non-Clinical Testing for Inadvertent Germline Transmission of Gene Transfer Vectors
Published: TGA Internet site
Effective: 1 May 2009 - CPMP/ICH/283/95
Note for Guidance on Impurities: Residual Solvents (CPMP/ICH/283/95)
Status: See also CPMP/QWP/450/03
Published: TGA Internet site
Effective: 1 May 2009 - CPMP/ICH/2738/99
Note for Guidance on Impurities in New Drug Products
Published: TGA Internet site
Effective: 1 May 2009 - EMEA/CHMP/BWP/505885/2008
Concept Paper on the revision of the Guideline on Epidemiological Data on Blood Transmissible Infections (EMEA/CPMP/BWP/125/04)
Published: TGA Internet site
Effective: 14 April 2009 - EMEA/CHMP/EWP/11877/2009
Concept Paper on the Need for a Guideline on the Treatment of Premenstrual Dysphoric Disorder (PMDD)
Published: TGA Internet site
Effective: 14 April 2009 - CPMP/EWP/252/03 Rev 1
Guideline on Clinical Medicinal Products Intended for the Treatment of Neuropathic Pain
Published: TGA Internet site
Effective: 14 April 2009 - CPMP/ICH/381/95
Note for Guidance on Validation of Analytical Procedures: Text and Methodology (CPMP/ICH/381/95) Rev 1
Published: TGA Internet site
Effective: 8 April 2009 - CHMP/EWP/358650/2006
Guideline on the Development of Medicinal Products for the Treatment of Post-Traumatic Stress Disorder (PTSD)
Published: TGA Internet site
Effective: 8 April 2009 - CHMP/EWP/18463/2006
Guideline on the Development of New Medicinal Products for the Treatment of Ulcerative Colitis
Published: TGA Internet site
Effective: 8 April 2009 - CHMP/EWP/263148/06
Guideline on Clinical Investigation of Immunosuppressants for Solid Organ Transplantation
Published: TGA Internet site
Effective: 8 April 2009 - CHMP/BMWP/101695/2006
Guideline on Comparability of Biotechnology-Derived Medicinal Products after a change in the Manufacturing Process – Non-Clinical and Clinical Issues
Published: TGA Internet site
Effective: 8 April 2009 - CHMP/GTWP/125459/2006
Guideline on the Non-Clinical Studies required before First Clinical Use of Gene Therapy Medicinal Products
Published: TGA Internet site
Effective: 8 April 2009 - EMEA/CHMP/SWP/194898/2006
Guideline on Carcinogenicity Evaluation of Medicinal Products for the Treatment of HIV Infection
Published: TGA Internet site
Effective: 6 April 2009 - pp 36-55, 96-101 and 202-203 of the Rules 2008 (Vol. 9A)
Requirements for Risk Management Systems
Published: TGA Internet site, 14 November 2008
Effective: 1 April 2009
Note: This guideline becomes effective on 1 April 2009. Prior to this date sponsors are encouraged to include a Risk Management Plan in submissions to the Office of Prescription Medicines - EMEA/CHMP/QWP/569959/2008
Concept Paper on the Revision of the Guideline on Parametric Release
Published: TGA Internet site
Effective: 23 March 2009 - EMEA/CHMP/EWP/27994/2008
APPENDIX 1 to the Guideline on the Evaluation of Anticancer Medicinal Products in Man (CHMP/EWP/205/95 REV. 3) - Methodological Considerations for Using Progression - Free Survival (PFS) as Primary Endpoint in Confirmatory Trials for Registration
Published: TGA Internet site
Effective: 16 March 2009 - CPMP/EWP/4937/03
Guideline on Non-Clinical and Clinical Development of Medical Products for the Prevention of Nausea and Vomiting Associated with Cancer Chemotherapy
Published: TGA Internet site
Effective: 16 March 2009 - EMEA/CHMP/PhVWP/235910/2005
Guideline on Conduct of Pharmacovigilance for Medicines Used by the Pediatric Population
Published: TGA Internet site
Effective: 16 March 2009 - Full list of EU guidelines ADOPTED in Australia
Guidelines replaced/superseded in the last 4 months
- pp. 373 - 380 of Rules 1998 (3A) - 3AB15a
Allergen Products
Replaces: III/9271/90 (Adopted by TGA August 1997) and is the same as CPMP/BWP/243/96
Published: TGA Internet site 12 February 2002
Status: Replaced by EMEA/CHMP/BWP/304831/2007 (Adopted by TGA 29 June 2009) - CPMP/QWP/1719/00
Note for Guidance on Medicinal Gases: Pharmaceutical Documentation
Published: TGA Internet Site
Effective: 12 March 2003
Status: Replaced by CPMP/QWP/1719/00 Rev 1 (Adopted by TGA 26 June 2009) - pp. 175 - 184 of Rules 1998 (3A) - 3AQ20a
Radiopharmaceuticals
Replaces: III/3936/89 (Adopted by TGA July 1994)
Published: TGA Internet site 12 February 2002
Status: Replaced by EMEA/CHMP/QWP/306970/2007 (Adopted by TGA 22 June 2009) - CPMP/ICH/1940/00 Corr
Maintenance of Note for Guidance on Impurities: Residual Solvents (CPMP/ICH/283/95) - Permissible Daily Exposure (PDE) for Tetrahydrofuran and N. Methylpyyrolidone
Published: TGA Internet Site 7 May 2003
Status: Replaced by CPMP/ICH/283/95 (Adopted by TGA 1 May 2009) - CPMP/ICH/1507/02
Maintenance Document for Note for Guidance on Impurities: Residual Solvents
Correction to CPMP/ICH/283/95 (Adopted TGA 29 November 2000)
Published: TGA Internet site 24 August 2004
Status: Replaced by CPMP/ICH/283/95 (Adopted by TGA 1 May 2009) - CPMP/ICH/283/95
Note For Guidance On Impurities: Residual Solvents
Published: TGA Internet Site 29 November 2000
Status: See also maintenance document CPMP/ICH/1507/02 (Adopted by TGA 24 August 2004)
Replaced: by CPMP/ICH/283/95 (Adopted by TGA 1 May 2009) - CPMP/ICH/2738/99
Note for Guidance on Impurities in New Drug Products
Published: TGA Internet site 16 August 2004
Status: Replaced by CPMP/ICH/2738/99 (Adopted by TGA 1 May 2009) - CHMP/EWP/252/03
Guideline on clinical investigation of medicinal products intended for the treatment of neuropathic pain
Published: TGA Internet site 1 June 2005
Status: Replaced by CPMP/EWP/252/03/Rev 1 (Adopted by TGA 14 April 2009) - pp. 107 - 117 of Rules 1998 (3A) - 3AQ13a
Validation of Analytical Procedures: Methodology
Replaces: CPMP/ICH/281/95 (Adopted by TGA 23 February 2001 - with comments) and pp. 1 - 16 of Rules Addendum
Published: TGA Internet site 12 February 2002
Status: Replaced by CPMP/ICH/381/95 (Adopted by TGA 8 April 2009) - pp. 119 - 125 of Rules 1998 (3A) - 3AQ14a
Validation of Analytical Procedures: Definitions and Terminology
Replaces: CPMP/ICH/381/95 (Adopted by TGA as III/5626/94 April 1996)
Published: TGA Internet site 12 February 2002
Status: Replaced by CPMP/ICH/381/95 (Adopted by TGA 8 April 2009) - EMEA/CPMP/3097/02
Guideline on Comparability of Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues
Published: TGA Internet site 12 May 2005
Status: Replaced by CHMP/BMWP/101695/2006 (Adopted by TGA 8 April 2009) - Full list of EU guidelines REPLACED or SUPERSEDED
Guidelines NOT adopted in the last 4 months
- EMEA/106464/2006 Rev 1
Guideline on the use of Statistical Signal Detection Methods in the Eudravigilance Data Analysis System
Published: TGA Internet site 25 March 2009 - CHMP/GTWP/125491/2006
Guideline on Scientific Requirements for the Environmental Risk Assessment of Gene Therapy Medicinal Products
Published: TGA Internet site 25 March 2009 - Full list of EU guidelines NOT adopted in Australia