Clinical guidelines
European Union guidelines adopted in Australia
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Please Note:
Where European Union (EU) guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of prescription medicines by the TGA. The Australian legislative requirements applying to prescription medicines are contained in the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990, as well as in various legislative instruments such as Therapeutic Goods Orders, Notices and Determinations, see Legislation <http://www.tga.gov.au/legis/index.htm>
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 Superseded by the Australian Regulatory Guidelines for Prescription Medicines (ARGPM)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 2008 (Vol. 9A) refers to: The Rules Governing Medicinal Products in the European Union - EudraLex - Volume 9A - Pharmacovigilance for Medicinal Products for Human Use (September 2008)
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
Alimentary tract and metabolism
CPMP/EWP/281/96 Rev.1 (pdf,106)
Guideline on Clinical Evaluation of Medicinal Products Used in Weight Control
Replaces: CPMP/EWP/281/96
Published: TGA Internet site
Effective: 26 March 2010
Adopted by the TGA with the following conditions:
"If a sponsor wishes to claim secondary benefits associated with weight loss (such as improved blood lipids, glycaemic control or blood pressure), then the relevant guidelines for these specific benefits should be independently satisfied"
CPMP/EWP/2284/99 Rev 1 (pdf,58kb)
Guideline on the Development of New Medicinal Products for the Treatment of Crohn's Disease
Replaces: CPMP/EWP/2284/99 (Adopted by TGA on 10 January 2002
Published: TGA Internet site
Effective: 25 February 2009
CHMP/EWP/18463/2006 (pdf,112kb)
Guideline on the Development of New Medicinal Products for the Treatment of Ulcerative Colitis
Published: TGA Internet site
Effective: 8 April 2009
EMEA/CHMP/EWP/517497/2007 (pdf,48kb)
Guideline on Clinical Evaluation of Medicinal Products Used in Weight Control (CPMP/EWP/281/96 Rev 1)
Addendum on Weight Control in Children
Published: TGA Internet site
Effective: 25 February 2009
Anti-infective product guidelines
CPMP/BWP/2289/01 (pdf,205kb)
Points to Consider on the Development of Live Attenuated Influenza Vaccines
Published: TGA Internet site
Effective: 17 September 2004
CPMP/EWP/463/97 (pdf,92kb)
Note for Guidance on Clinical Evaluation of New Vaccines
Published: TGA Internet site
Effective: 6 February 2002
Adopted by the TGA with the following notation:
"Sponsors in Australia should provide data on the consistency of full scale manufacturing lots in respect of clinical safety and efficacy (immunogenicity) or justify the absence of such data"
EMEA/CHMP/EWP/30039/2008 (pdf,136kb)
Guideline on the Clinical Evaluation of Direct Acting Antiviral Agents Intended for Treatment of Chronic Hepatitis C
Published: TGA Internet site
Effective: 28 May 2010
EMEA/CPMP/EWP/633/02 Rev 2 (pdf,205kb)
Guideline on the Clinical Development of Medicinal Products for the Treatment of HIV Infection
Replaces: CPMP/EWP/633/02 Rev 1 (Adopted by TGA 15 June 2006), CPMP/EWP/633/02 (Adopted by TGA February 2004, which replaced CPMP/602/95 Rev 3)
Published: TGA Internet site
Effective: 15 July 2009
CPMP/EWP/863/98 (pdf,38kb)
Points To Consider on Wording of Helicobacter Pylori Eradication Therapy in Selected SPC Sections
Published: TGA Internet site
Effective: 15 December 2000
CPMP/EWP/1343/01 (pdf,266kb)
Points to Consider on the Clinical Evaluation of New Agents for Invasive Fungal Infections
Published: TGA Internet site
Effective: 17 September 2008
CPMP/EWP/2655/99 (pdf,86kb)
Points to Consider on Pharmacokinetics and Pharmacodynamics in the Development of Antibacterial Medicinal Products
Published: TGA Internet site
Effective: 19 April 2001
CHMP/EWP/4713/03 (pdf,67kb)
Guideline on Clinical Investigation of Medicinal Products for the Treatment of Sepsis
Published: TGA Internet site
Effective: 29 September 2006
CPMP/EWP/6172/03 (pdf,126kb)
Guideline on the Clinical Evaluation of Medicinal Products intended for Treatment of Hepatitis B
Published: TGA Internet site
Effective: 1 September 2006
EMEA/CHMP/EWP/122355/2007 (pdf,85kb)
Concept Paper on Preparation of an Adendum to the Guideline on Development of Antibacterial Agents to Specifically Address the Clinical Development of New Agents to Treat Tuberculosis
Published TGA Internet site for information only, effective: 10 February 2009
EMEA/CHMP/EWP/435635/2008 (pdf,52kb)
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 for information only, effective: 1 May 2009
EMEA/CHMP/VEG/134716/2004 (pdf,189kb)
Guideline on Adjuvants in Vaccines for Human Use
Published: TGA Internet site
Effective: July 2005
Blood product guidelines
CPMP/BPWG/198/95 Rev 1 (pdf,115kb)
Note for Guidance on the Clinical Investigation of Human Plasma Derived Factor VIII and IX Products
Replaces: CPMP/BPWG/198/95 Rev 1, Note for Guidance to Assess Efficacy and Safety of Human Plasma Derived Factor VIII:C and Factor IX:C Products in Clinical Trials in Haemophiliacs Before and After Authorisation
Published: TGA Internet site
Effective: 17 September 2004
CPMP/BPWG/220/02 (pdf, 139kb)
Guideline on the Clinical Investigation of Human Plasma Derived Von Willebrand Factor Products
Published: TGA Internet site
Effective: 1 June 2006
CPMP/BPWG/283/00 (pdf,182kb)
Note for Guidance on the Clinical Investigation of Human Normal Immunoglobulin for Subcutaneous and Intramuscular Use
Published: TGA Internet site
Effective: 12 March 2003
CPMP/BPWG/388/95 Rev 1 (pdf,48kb)
Note for Guidance on the Clinical Investigation of Human Normal Immunoglobulin for Intravenous Administration (IVIg)
Published: TGA Internet site
Effective: 19 April 2001
CPMP/BPWG/575/99 Rev 1 (pdf,117kb)
Guideline on the Clinical Investigation of Human Anti-D Immunoglobulin for Intravenous and/or Intramuscular Use
Replaces: CPMP/BPWG/575/99 (Adopted by TGA 19 April 2001)
Published: TGA Internet site
Effective: 10 February 2009
CPMP/BPWG/1089/00 (pdf,61kb)
Guideline on the clinical investigation of Plasma derived Fibrin Sealant/Haemostatic Products
Published: TGA Internet Site
Effective: 13 January 2005
CPMP/BPWG/1561/99 (pdf,111kb)
Note for Guidance on the Clinical Investigation of Recombinant Factor VIII and IX Products
Published: TGA Internet site
Effective: 19 April 2001
EMEA/CHMP/BWP/505885/2008 (pdf,51kb)
Concept Paper on the revision of the Guideline on Epidemiological Data on Blood Transmissible Infections (EMEA/CPMP/BWP/125/04)
Published TGA Internet site for information only, effective: 14 April 2009
EMEA/CHMP/BWP/125/04 (pdf,211kb)
Guideline on Epidemiological Data on Blood Transmissible Infections
Published: TGA Internet site
Effective: 19 September 2008
Cardio-vascular system guidelines
pp. 297 - 306 of Rules 1998 (3C) - 3CC21a (pdf,45kb)
Medicinal Products for the Treatment of Arrhythmias
Replaces: CPMP/EWP/237/95 (Adopted by TGA August 1997) & pp. 199 - 207 of Rules 1989
Effective: 12 February 2002
CPMP/EWP/234/95 Rev 1 (pdf,63kb)
Guideline on The Clinical Investigation of Anti-Anginal Medicinal Products in Stable Angina Pectoris
Replaces: pp. 289 - 296 of Rules 1998 (3C) - 3CC20a (Adopted by TGA 12 February 2002)
CPMP/EWP/234/95 (Adopted by TGA August 1997)
and pp. 187 - 190 of Rules 1989
Published: TGA Internet site
Effective: 29 September 2006
CPMP/EWP/235/95 Rev 1 (pdf,63kb)
Note for Guidance on the Clinical Investigation of Medicinal Products in the Treatment of Cardiac Failure
Published: TGA Internet site
Effective: 23 February 2001
CPMP/EWP/238/95 Rev 2 (pdf,100kb)
Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Hypertension
Published: TGA Internet site
Replaces: CPMP/EWP/238/95 Rev 1 (Adopted by the TGA April 2000, which replaced III/5931/94)
Effective: 15 June 2006
EMEA/CHMP/EWP/350495/2009 (pdf,37kb)
Concept Paper on the Need to Update the Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Lipid Disorders (CPMP/EWP/3020/03) and the Note for Guidance on the Clinical Investigation on Medicinal Products in the Treatment of Hypertension (CPMP/EWP/238/95 REV. 2) to Discuss the Need for Outcome Studies Basis on Safety Data at the Time of MAA.
Published TGA Internet site for information only, effective: 26 March 2010
EMEA/CHMP/EWP/356954/2008 (pdf,60kb)
Guideline on the Clinical Investigations of Medicinal Products for the Treatment of Pulmonary Arterial Hypertension
Published: TGA Internet site
Effective: 28 May 2010
EMEA/CHMP/EWP/545456/2008 (pdf,93kb)
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 for information only, effective: 1 May 2009
EMEA/CHMP/EWP/644261/2008 (pdf,47kb)
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 for information only, effective: 1 May 2009
CPMP/EWP/560/98 (pdf,68kb)
Points to Consider on Clinical Investigation of Medicinal Products for the Treatment of Acute Stroke
Published: TGA Internet site
Effective: 4 September 2002
CPMP/EWP/563/98 (pdf,45kb)
Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Venous Thromboembolic Disease
Published: TGA Internet site
Effective: 25 January 2001
CPMP/EWP/570/98 (pdf,65kb)
Points to Consider on the Clinical Investigation of New Medicinal Products in the Treatment of Acute Coronary Syndrome (ACS) Without Persistent ST-Segment Elevation
Published: TGA Internet site
Effective: 19 April 2001
CPMP/EWP/707/98 Rev 1 corr (pdf,65kb)
Guideline on Clinical Investigation of Medicinal Products for Prophylaxis of High Intra- and Post-Operative Venous Thromboembolic Risk
Published: TGA Internet site
Replaces: CPMP/EWP/707/98 (adopted by the TGA 25 January 2008)
Effective: 8 December 2008
CPMP/EWP/714/98 Rev 1 (pdf,180kb)
Note For Guidance on Clinical Investigation of Medicinal Products for the Treatment of Peripheral Arterial Occlusive Disease
Published: TGA Internet site
Effective: 7 May 2003
CPMP/EWP/967/01 (pdf,187kb)
Points to Consider on the Clinical Development of Fibrinolytic Medicinal Products in the Treatment of Patients with St Segment Elevation Acute Myocardial Infarction (Stemi)
Published: TGA Internet site
Effective: 17 September 2004
CPMP/EWP/2986/03 (pdf,210kb)
Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Cardiac Failure. Addendum on CPMP/EWP/235/95 Rev 1
Published: TGA Internet site
Effective: 1 February 2007
CPMP/EWP/6235/04 (pdf,62kb)
Guideline on Clinical Investigation of Medicinal Products for the Prophylaxis of Venous Thromboembolic Risk in Non-Surgical Patients
Published: TGA Internet site
Effective: 29 September 2006
EMEA/CHMP/EWP/311890/2007 (pdf,105kb)
Guideline on the Evaluation of Medicinal Products for Cardiovascular Disease Prevention
Published: TGA Internet site
Effective: 29 June 2009
CHMP/ICH/2/04 (pdf,169kb)
Note for Guidance on Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
Published: TGA Internet site
Effective: 9 February 2006
Adopted by the TGA with the following notation:
QT prolongation would be of regulatory concern if either the estimated QT prolongation was >5ms OR the upper bound of the 95% confidence interval was >10ms
Clinical pharmacology and pharmacokinetics guidelines
pp. 99 - 106 of Rules 1998 (3C) - 3CC3a (pdf,39kb)
Pharmacokinetic Studies in Man
Replaces: pp. 153 - 157 of Rules 1989
Effective: 12 February 2002
CHMP/EWP/225/02 (pdf,214kb)
Note for guidance on the evaluation of the Pharmacokinetics of medicinal products in patients with impaired renal function
Published: TGA Internet site
Effective: 24 November 2004
CHMP/EWP/89249/2004 (pdf,89kb)
Guideline on the Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins
Published: TGA Internet site
Effective: 6 January 2009
CHMP/EWP/185990/06 (pdf,64kb)
Guideline on Reporting the results of Population Pharmacokinetic Analysis
Published: TGA Internet site
Effective: 27 January 2009
CPMP/EWP/280/96 (pdf,90kb)
Note for Guidance on Modified Release Oral and Transdermal Dosage Forms: Section II (Pharmacokinetic and Clinical Evaluation)
Published: TGA Internet site
Effective: 14 March 2001
Replaces: pp. 181 - 192 of Rules 1998 (3C) - 3CC11a
Adopted by TGA with the following conditions:
"For multiple strengths of generic TDDS products, bioequivalence studies should be performed at least on the lowest and highest strengths versus the corresponding innovator products. If an applicant considers that this is unnecessary in a particular case, a justification for not submitting bioequivalence data should be submitted in accordance with Section 4 of Appendix 15 (Biopharmaceutic studies) of the ARGPM."
EMEA/CHMP/EWP/297931/2008 (pdf,32kb)
Concept Paper/Recommendation on the Need for Revision of (CHMP) Note for Guidance on the Investigation of Drug Interactions (CPMP/EWP/560/95)
Published TGA Internet site for information only, effective: 10 February 2009
CPMP/EWP/560/95 (pdf,79kb)
Note for Guidance on the Investigation of Drug Interactions
Published: TGA Internet site
Effective: 19 April 2001
CPMP/EWP/2339/02 (pdf,92kb)
Guideline on the Evaluation of the Pharmacokinetics of Medicinal Products in Patients with Impaired Hepatic Function
Published: TGA Internet site
Effective: 4 January 2006
CHMP/EWP/147013/2004 (pdf,103kb)
Guideline on the role of Pharmacokinetics in the Development of Medicinal Products in the Paediatric Population (corregendum)
Published: TGA Internet site
Effective: 24 August 2009
CPMP/EWP/QWP/1401/98 (pdf,147kb)
Note for Guidance on the Investigation of Bioavailability and Bioequivalence
Replaces: pp. 231 - 244 of Rules 1998 (3C) (Adopted by TGA 12 February 2002)
Published: TGA Internet site
Effective: 10 April 2002
Adopted by TGA with the following notation:
"While this guidance suggests that the design and conduct of the study should follow EU regulations on Good Clinical Practice, sponsors should note that the EU Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) has been adopted in Australia with TGA annotations.
The procedure for abridged applications claiming essential similarity to a reference product (ie, generics), which allows applications to be made to numerous Member States of the EU, based on bioequivalence with a reference product from one Member State, does not apply in Australia. An application for registration of a generic product in Australia should generally include a bioequivalence study versus a leading brand obtained in Australia."
CPMP/ICH/289/95 (pdf,79kb)
Note for Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data
Published: TGA News April 2000
Effective: 1 May 2000
CPMP/ICH/378/95 (pdf,98kb)
Note For Guidance on Dose Response Information to Support Drug Registration
Published: TGA Internet site
Effective: 15 December 2000
CHMP/SWP/28367/2007 (pdf,79kb)
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
Clinical safety guidelines
Appendix 20 - AGRD
Australian Pharmacovigilance Guideline (August 2002)
Published: TGA Internet site
Effective: 1 July 2002 (with a six-month transition period)
*Large file warning: Attempting to open large pdf files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.
pp. 21 - 32 and 139 - 145 of Rules 2001 (Vol. 9) (pdf,762kb)
Periodic Safety Update Reports (PSURs) Sections 1.4 and 3 of Part 1
Published: TGA Internet site
Effective: 2 October 2002
pp 36-55, 96-101 and 202-203 of the Rules 2008 (Vol. 9A) (pdf,288kb)
Requirements for Risk Management Systems
(EMEA/CHMP/96268/2005)
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.
pp. 121 - 125 of Rules 1998 (3C) - 3CC5a (pdf,25kb)
The Extent of Population Exposure to Assess Clinical Safety for Medicines Intended for Long-Term Treatment of Non-Life-Threatening Conditions
Replaces: CPMP/ICH/375/95 (Adopted by TGA as III/5084/94 with conditions)
Effective: 12 February 2002
Adopted by the TGA with the following conditions:
Attention is drawn to:
- Applicability, Section 7, which states that circumstances exist in which the Guidelines may not be applicable. It should be noted that the listing of exceptional circumstances is not exhaustive. Sponsors should give careful attention to whether, in any particular instance, the clinical safety of the product would be adequately supported by the numbers of subjects proposed, and;
- Supplementary data, Section 8 is NOT ADOPTED. To permit decisions within legislated timeframes, the sponsor should include in the initial submission all clinical safety data necessary to support registration.
See also: pp.127 - 132 of Rules 1998 3C - 3CC6a
pp. 127 - 132 of Rules 1998 (3C) - 3CC6a (pdf,27kb)
Clinical Investigation of Medicinal Products for Long-Term Use
Replaces: pp. 163 - 165 of Rules 1989
Effective: 12 February 2002
See also: pp. 121 - 125 of Rules 1998 (3C) - 3CC5a (Adopted by TGA with conditions)
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/377/95
Note For Guidance On Clinical Safety Data Management: Definitions And Standards For Expedited Reporting - Annotated with TGA comments
Published: TGA News October 2000
Effective: 1 August 2000
CPMP/ICH/4679/02 (pdf,160kb)
Clinical Safety Data Management - Periodic Safety Update Reports for Marketed Drugs (Addendum to ICH E2C - CPMP/ICH/288/95)
Published: TGA Internet site
Effective: 7 June 2005
CPMP/ICH/5716/03 (pdf,225kb)
Note for Guidance on Planning Pharmacovigilance Activities
Published: TGA Internet site
Effective: 10 August 2005
EMEA/CHMP/PhVWP/235910/2005 (pdf,110kb)
Guideline on Conduct of Pharmacovigilance for Medicines Used by the Pediatric Population
Published: TGA Internet site
Effective: 16 March 2009
EMEA/CHMP/313666/2005 (pdf,275kb)
Note for Guidance on the Exposure to Medicinal Products during Pregnancy: Need for Post Authorisation Data
Published: TGA Internet site
Effective: 26 February 2009
Endocrinology guidelines
pp. 341 - 346 of Rules 1998 (3C) - 3CC25a (pdf,30kb)
Clinical Investigation of Oral Contraceptives
Replaces: pp. 169 - 171 of Rules 1989
Effective: 12 February 2002
EMEA/CHMP/021/97 Rev 1 (pdf,61kb)
Guideline on Clinical Investigation of Medicinal Products for the Treatment of Hormone Replacement Therapy of Oestrogen Deficiency Symptoms in Postmenopausal Women
Published: TGA Internet site
Replaces: CPMP/EWP/021/97 (Adopted by TGA 15 December 2000)
Effective: 9 February 2006
EMEA/CPMP/EWP/519/98 rev 1 (pdf,59kb)
Note for Guidance on Clinical Investigation of Steroid Contraceptives in Women
Published: TGA Internet site
Replaces: EMEA/CPMP/EWP/519/98 (Adopted by TGA 19 April 2001)
Effective: January 2006
CPMP/EWP/1080/00 (pdf,188kb)
Note for Guidance on Clinical Investigation of Medicinal Products
in the Treatment of Diabetes Mellitus
Published: TGA Internet site
Effective: 23 October 2002
Gene therapy
EMEA/CHMP/GTWP/607698/2008 (pdf,55kb)
ICH Considerations
Oncolytic Viruses
Published: TGA Internet site
Effective: 28 May 2010
General guidelines
pp. 127 - 132 of Rules 1998 (3C) - 3CC6a (pdf,27kb)
Clinical Investigation of Medicinal Products for Long-Term Use
Replaces: pp. 163 - 165 of Rules 1989
Effective: 12 February 2002
See also: pp. 121 - 125 of Rules 1998 (3C) - 3CC5a (Adopted by TGA with conditions)
pp. 193 - 198 of Rules 1998 (3C) - 3CC12a (pdf,30kb)
Clinical Requirements for Locally Applied, Locally Acting Products, Containing Known Constituents
Replaces: CPMP/EWP/239/95 (Adopted by TGA August 1997)
Effective: 12 February 2002
pp. 381 - 391 of Rules 1998 (3C) - 3CC29a (pdf,52kb)
Investigation of Chiral Active Substances
Replaces: III/3501/91 (Adopted by TGA 1 January 1995)
Effective: 12 February 2002
CPMP/EWP/240/95 Rev. 1 (pdf,81kb)
Guideline on Clinical Development of Fixed Combination Medicinal Products
Replaces: pp. 175 - 180 of Rules 1998 (3C) - 3CC10a
Published: TGA Internet site
Effective: 28 May 2010
CPMP/EWP/482/99 (pdf,109kb)
Points to Consider on Switching between Superiority and Non-inferiority
Published: TGA Internet site
Effective: 29 June 2001
Adopted by the TGA with the following notation:
"Please note that there is no requirement in Australia to demonstrate superiority."
CPMP/EWP/908/99 (pdf,210kb)
Points to Consider on Multiplicity Issues in Clinical Trials
Published: TGA Internet site
Effective: 23 June 2005
CPMP/EWP/1119/98 Rev.1 (pdf113kb)
Clinical Evaluation of Diagnostic Agents
Replaces: CPMP/EWP/1119/98
Published: TGA Internet site
Effective: 28 May 2010
EMEA/CHMP/EWP/321180/2008 (pdf,54kb)
Appendix 1 to the Guideline on Clinical Evaluation of Diagnostic Agents (CPMP/EWP/1119/98 Rev. 1) on Imaging Agents
Published: TGA Internet site
Effective: 28 May 2010
CPMP/EWP/1776/99 (pdf,38kb)
Points to Consider on Missing Data
Published: TGA Internet site
Effective: 12 March 2003
EMEA/CPMP/EWP/2158/99 (pdf,116kb)
Guideline on the Choice of the Non-Inferiority Margin
Published: TGA Internet site
Effective: January 2006
CPMP/EWP/2330/99 (pdf,51kb)
Points to Consider on Application with
1. Meta-Analyses;
2. One Pivotal Study
Published: TGA Internet site
Effective: 27 March 2002
Adopted by the TGA with the following notation:
"Sponsors are reminded that they should submit all available new safety data that are relevant to the intended treatment population."
CPMP/EWP/2747/00 (pdf,113kb)
Note for Guidance on Coordinating Investigator Signature of Clinical Study Reports
Published: TGA Internet site
Effective: 12 March 2003
CPMP/EWP/2863/99 (pdf,221kb)
Points to Consider on Adjustment for Baseline Covariates
Published: TGA Internet site
Effective: 20 May 2005
EMEA/CHMP/EWP/5872/03 corr (pdf,74kb)
Guideline on Data Monitoring Committees
Replaces: EMEA/CHMP/EWP/5872/03 (Adopted by TGA January 2006)
Published: TGA Internet site
Effective: 23 March 2006
CHMP/EWP/18504/2006 (pdf,167kb)
Guideline on the Clinical Development of Products for Specific Immunotherapy for the Treatment of Allergic Diseases
Published: TGA Internet site
Effective: 15 July 2009
CHMP/EWP/83561/2005 (pdf,63kb)
Guideline on Clinical Trials in Small Populations
Published: TGA Internet site
Effective: December 2006
EMEA/CHMP/EWP/604040/2009 (pdf,49kb)
Concept Paper on the Need for a Guideline on the Clinical Investigation of Medicinal Products Intended for Treatment of Systematic and Cutaneous Lupus Erythematosus
Published TGA Internet site for information only, effective: 26 March 2010
CPMP/ICH/135/95
Note for Guidance on Good Clinical Practice - Annotated with TGA comments
Published: TGA News October 2000
Effective: 1 August 2000
CPMP/ICH/137/95 (pdf,114kb)
Note for Guidance on Structure and Content of Clinical Study Reports
Published: TGA News April 2000
Effective: 1 May 2000
CPMP/ICH/291/95 (pdf,118kb)
Note for Guidance on General Considerations for Clinical Trials
Published: TGA News September 1999
Effective: 1 October 1999
CPMP/ICH/363/96 (pdf,170kb)
Note for Guidance on Statistical Principles for Clinical Trials
Replaces: III/3630/92 (Adopted by TGA April 1996) and pp. 133 - 158 of Rules 1998 (3C)
Published: TGA News September 1999
Effective: 1 October 1999
CPMP/ICH/364/96 (pdf,229kb)
Note for Guidance on Choice of Control Groups in Clinical Trials
Published: TGA Internet site
Effective: 19 April 2001
CHMP/EWP/263148/06 (pdf,150kb)
Guideline on Clinical Investigation of Immunosuppressants for Solid Organ Transplantation
Published: TGA Internet site
Effective: 8 April 2009
EMEA/CHMP/ICH/437986/2006 (pdf,46kb)
Note for Guidance on Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
Published: TGA Internet site
Effective: 25 February 2009
Genitourinary guidelines
CPMP/EWP/18/01 (pdf,168kb)
Note for Guidance on the Clinical Investigation of Medicinal Products for the Treatment of Urinary Incontinence
Published: TGA Internet site
Effective: 4 February 2004
Haematology/cancer guidelines
CPMP/EWP/197/99 (pdf,44kb)
Points to Consider Concerning Endpoints in Clinical Studies with Haematopoeitic Growth Factors for Mobilisation of Autologous Stem Cells
Published: TGA Internet site
Effective: 19 April 2001
EMEA/EWP/205/95 Rev 3 Corr (pdf,133kb)
Guideline on the Evaluation of Anticancer Medicinal Products in Man
Replaces: CPMP/EWP/205/95 Rev 1 Corr (Adopted by TGA January 2002), CPMP/EWP/205/95 (Adopted by TGA April 2000) pp.117-133 of Rules Addendum, and pp. 315-331of Rules 1998 (3C) - 3CC23a
Replaces: CPMP/EWP/205/95 Rev 2 Corr (Adopted by TGA 15 September 2005)
Published: TGA Internet site
Effective: June 2006
EMEA/CPMP/555/95 Rev 1 (pdf,58kb)
Guideline on Clinical Trials with Haematopoietic Growth Factors for the Prophylaxis of Infection Following Myelosuppressive or Myeloablative Therapy
Replaces: pp. 333 - 340 of Rules 1998 (3C) - 3CC24a (Adopted by TGA 12 February 2002) and CPMP/EWP/555/95 (Adopted by TGA 1 May 2000, with conditions)
Published: TGA Internet site
Effective: 15 July 2009
CPMP/BPWG/2220/99 (pdf,169kb)
Note for Guidance on the Clinical Investigation of Plasma Derived Antithrombin Products
Published: TGA Internet site
Effective: 16 October 2003
Adopted by the TGA with the following notation:
"If a sponsor believes that the patient numbers specified in this guideline are not achievable in Australia, advice should be sought from the TGA."
CPMP/EWP/4937/03 (pdf,109kb)
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/EWP/27994/2008 (pdf,38kb)
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
Medicinal product guidelines
pp. 119 - 128 of Rules 1997 (4) - anx13en (pdf,74kb)
Annex 13 - EudraLex Volume 4
Manufacture of Investigational Medicinal Products (1997)
Replaces: III/3004/91
Effective: 15 September 1999
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/EWP/1875/03 (pdf,147kb)
Points to Consider on the Clinical Requirements of Modified Release Products Submitted as a Line Extension of an Existing Marketing Authorisation
Published: TGA Internet site
Effective: 7 June 2005
CPMP/EWP/3020/03 (pdf,181kb)
Note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders
Published: TGA Internet site
Effective: 20 May 2005
Miscellaneous clinical guidelines
III/3366/91
Procedure for Pharmacovigilance Exchange of Information within the Working Party
Published: AGRD
Effective: 1 January 1993
pp. 347 - 357 of Rules 1998 (3C) - 3CC26a (pdf,53kb)
Clinical Investigation of Corticosteroids Intended for Use on the Skin
Replaces: pp. 181 - 186 of Rules 1989
Effective: 12 February 2002
CPMP/EWP/785/97 (pdf,176kb)
Points to Consider on the Evaluation of Medicinal Products for the Treatment of Irritable Bowel Syndrome
Published: TGA Internet site
Effective: 17 September 2004
CHMP/EWP/2454/02 (pdf,276kb)
Guideline on clinical investigation of medicinal products indicated for the treatment of Psoriasis
Published: TGA Internet site
Effective: 28 July 2005
Adopted by the TGA with the following notation:
Section 5.2.5 on this guideline suggests that regulatory approval requires a comparison with an active comparator (eg cyclosporin, methotrexate etc). Placebo-controlled studies may also be acceptable in Australia.
CPMP/EWP/3020/03 (pdf,181kb)
Note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders
Published: TGA Internet site
Effective: 20 May 2005
Nervous system guidelines
pp. 359 - 370 of Rules 1998 (3C) - 3CC27a (pdf,58kb)
Clinical Investigation of Hypnotic Medicinal Products
Replaces: III/3855/89 (Adopted by TGA July 1994)
Effective: 12 February 2002
CPMP/EWP/49/01 (pdf,151kb)
Appendix to the Note for Guidance on the Clinical Investigation of Medicinal Products in the Treatment of Schizophrenia (CPMP/EWP/559/95) - Methodology of Clinical Trials Concerning the Development of Depot Preparations of Approved Medicinal Products in Schizophrenia
Published: TGA Internet site
Effective: 17 September 2004
CPMP/EWP/252/03 Rev 1 (pdf,105kb)
Guideline on Clinical Medicinal Products Intended for the Treatment of Neuropathic Pain
Replaces: CHMP/EWP/252/03 (Adopted by TGA 1 June 2005)
Published: TGA Internet site
Effective: 14 April 2009
CPMP/EWP/518/97 Rev 1 (pdf,160kb)
Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Depression
Replaces: pp. 307 - 313 of Rules 1998 (3C) - 3CC22a
Published: TGA Internet site
Effective: 7 August 2002
CPMP/EWP/553/95 Rev 1 (pdf,137kb)
Guideline on Medicinal Products for the Treatment of Alzheimer's Disease and Other Dementias
Replaces: CPMP/EWP/553/95 (Adopted by TGA 1 May 2000)
Published: TGA Internet site
Effective: 25 February 2009
CPMP/EWP/559/95 (pdf,67kb)
Note for Guidance on the Clinical Investigation of Medicinal Products in the Treatment of Schizophrenia
Published: TGA News April 2000
Effective: 1 May 2000
CPMP/EWP/561/98 Rev 1 (pdf,145kb)
Guideline on clinical investigation of Medicinal Products for the Treatment of Multiple Sclerosis
Replaces: CPMP/EWP/561/98 (Adopted by TGA 10 January 2002)
Published: TGA Internet site
Effective: 1 December 2008
CPMP/EWP/563/95 Rev 1 (pdf,155kb)
Guideline on Clinical Investigation of Medicinal Products in the Treatment of Parkinson's Disease
Replaces: CPMP/EWP/563/95 (Adopted by TGA 1 May 2000)
Published: TGA Internet site
Effective: 25 February 2009
CPMP/EWP/565/98 (pdf,59kb)
Points to Consider on Clinical Investigation of Medicinal Products for the Treatment of Amyotrophic Lateral Sclerosis (ALS)
Published: TGA Internet site
Effective: 23 February 2001
CPMP/EWP/566/98 Rev 1 (pdf,98kb)
Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Epileptic Disorders
Replaces: pp. 177 - 179 of Rules (Adopted by TGA July 1994), pp. 135 - 146 of Rules Addendum and pp. 277 - 287 of Rules 1998 (3C)
Published: TGA Internet site
Effective: 19 April 2001
CPMP/EWP/567/98 (pdf,79kb)
Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Bipolar Disorder
Published: TGA Internet site
Effective: 30 August 2001
CPMP/EWP/612/00 (pdf,184kb)
Note for Guidance on Clinical Investigation of Medicinal Products for Treatment of Nociceptive Pain
Published: TGA Internet site
Effective: 12 May 2005
CPMP/EWP/788/01 Rev 1 (pdf,63kb)
Guideline on Clinical Investigation of Medicinal Products for the Treatment of Migraine
Replaces: CPMP/EWP/788/01 (Adopted by TGA 19 April 2001)
Published: TGA Internet site
Effective: 10 February 2009
CHMP/EWP/3635/03 (pdf,71kb)
Guideline on Clinical Investigation of Medicinal Products Indicated for the Treatment of Social Anxiety Disorder (SAD)
Published: TGA Internet site
Effective: August 2006
CHMP/EWP/4279/02 (pdf,79kb)
Guideline on Clinical Investigation of Medicinal Products for the Treatment of Obsessive Compulsive Disorder
Published: TGA Internet site
Replaces: pp. 371 - 380 of Rules 1998 (3C) - 3CC28a (Adopted by TGA 12 February 2002)
Effective: July 2005
CHMP/EWP/4280/02 (pdf,89kb)
Guideline on the Clinical Investigation of Medicinal Products Indicated for the Treatment of Panic Disorder
Published: TGA Internet site
Replaces: pp. 371 - 380 of Rules 1998 (3C) - 3CC28a (Adopted by TGA 12 February 2002)
Effective: July 2005
CPMP/EWP/4284/02 (pdf,73kb)
Guideline on the Clinical Investigation of Medicinal Products Indicated for Generalised Anxiety Disorder
Published: TGA Internet site
Replaces: pp. 371 - 380 of Rules 1998 (3C) - 3CC28a (Adopted by TGA 12 February 2002)
Effective: July 2005
EMEA/CHMP/EWP/11877/2009 (pdf,53kb)
Concept Paper on the Need for a Guideline on the Treatment of Premenstrual Dysphoric Disorder (PMDD)
Published TGA Internet site for information only, effective: 14 April 2009
EMEA/CHMP/EWP/358650/2006 Corr 2* (pdf,68kb)
Guideline on the Development of Medicinal Products for the Treatment of Post-Traumatic Stress Disorder (PTSD)
* The correction includes minor wording changes in Sections 1 and 4, an additional sentence at the end of General Recommendations under the heading Clinical Safety Evaluation of Section 4 and the additional sentence 'Alternatively, if different types of patients are included in the same trials then randomization should take place with strata defined by type of onset.' in pages 5 and 6.
Replaces: CHMP/EWP/358650/2006 (Adopted by TGA 8 April 2009)
Published: TGA Internet site
Effective: 23 February 2010
CHMP/EWP/369963/05 (pdf,122kb)
Guideline on the Development of Medicinal Products for theTreatment of Smoking
Published: TGA Internet site
Effective: 5 August 2009
EMEA/CHMP/EWP/484366/2009 (pdf,40kb)
Concept Paper on the Need for Revision of Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Depression with Regard to Treatment Resistant Depression
Published TGA Internet site for information only, effective: 23 February 2010
Paediatric guidelines
EMEA/536810/2008 (pdf,171kb)
Guideline on the Investigation of Medicinal Products in the Term and Preterm Neonate
Published: TGA Internet site
Effective: 28 May 2010
EMEA/CHMP/PEG/194810/2005 (pdf,198kb)
Reflection Paper: Formulations of Choice for the Paediatric Population
Published: TGA Internet site
Effective: 29 June 2009
Pharmacogenomics
EMEA/CHMP/PGxWP/201914/2006 (pdf,48kb)
Reflection Paper on Pharmacogenomic Samples, Testing and Data Handling
Published: TGA Internet site
Effective: 29 June 2009
Respiratory system guidelines
EMEA/CPMP/EWP/504/97 Rev 1 (pdf,94kb)
Guideline On Clinical Investigation of Medicinal Products in the Treatment of Patients with Acute Respiratory Distress Syndrome
Published: TGA Internet site
Effective: 7 October 2008
CPMP/EWP/562/98 (pdf,37kb)
Points to Consider on Clinical Investigation of Medicinal Products in the Treatment of Patients with Chronic Obstructive Pulmonary Disease (COPD)
Published: TGA Internet site
Effective: 19 April 2001
EMEA/CHMP/EWP/8197/2009 (pdf,66kb)
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 for information only, effective: 1 May 2009
CHMP/EWP/2455/02 (pdf,202kb)
Guideline on the clinical development of medicinal products for the treatment of allergic rhino-conjunctivitis
Published: TGA Internet site
Effective: 28 July 2005
CPMP/EWP/2922/01 (pdf,173kb)
Note for Guidance on the Clinical Investigation of Medicinal Products in the Treatment of Asthma
Published: TGA Internet site
Effective: 7 January 2009
CPMP/EWP/4151/00 Rev 1 (pdf,271kb)
Guideline on the Requirements for Clinical Documentation for Orally Inhaled Products (OIP) Including the Requirements for Demonstration of Therapeutic Equivalence Between Two Inhaled Products for Use in the Treatment of Asthma and Chronic Obstructive Pulmonary Disease (COPD) in Adults and for Use in the Treatment of Asthma in Children and Adolescents
Replaces: CPMP/EWP/4151/00 (Adopted by TGA January 2005)
Published: TGA Internet site
Effective: 23 February 2010
Rheumatology guidelines
pp. 257 - 261 of Rules 1998 (3C) - 3CC17a (pdf,25kb)
Medicinal Products (Non-Steroidal Anti-Inflammatory Compounds) for the Treatment of Chronic Disorders
Replaces: pp. 175 - 176 of Rules 1989
Effective: 12 February 2002
CPMP/EWP/552/95 Rev 2 (pdf,61kb)
Guideline on the Evaluation of Medicinal Products in the Treatment of Primary Osteoporosis
Published: TGA Internet site
Effective: 7 August 2008
CPMP/EWP/556/95 Rev 1 (pdf,176kb)
Points to Consider on Clinical Investigation of Medicinal Products other than NSAIDS for Treatment of Rheumatoid Arthritis
Replaces: CPMP/EWP/556/95 (Adopted by TGA February 2001)
Published: TGA Internet site
Effective: 29 January 2007
CPMP/EWP/784/97 (pdf,53kb)
Points To Consider on Clinical Investigation of Medicinal Products Used in the Treatment of Osteoarthritis
Published: TGA Internet site
Effective: 15 December 2000
CPMP/EWP/422/04 (pdf,117kb)
Guideline on Clinical Investigation of Medicinal Products for the Treatment of Juvenile Idiopathic Arthritis
Published: TGA Internet site
Effective: 26 June 2009
EMEA/CHMP/EWP/438/04 (pdf,125kb)
Guideline on Clinical Investigation of Medicinal Products for the Treatment of Psoriatic Arthritis
Published: TGA Internet site
Effective: 5 February 2008
CPMP/EWP/4891/03 (pdf,78kb)
Guideline on Clinical Investigation of Medicinal Products for the Treatment of Ankylosing Spondylitis
Published: TGA Internet site
Effective: 23 February 2010
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/14327/2006 (pdf,160kb)
Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins
Published: TGA Internet site
Effective: 22 June 2009
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/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/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/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
CHMP/BMWP/101695/2006 (pdf,115kb)
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
EMEA/CHMP/BMWP/114720/2009 (pdf,43kb)
Concept Paper on Immunogenicity Assessment of Monoclonal Antibodies Intended for In Vivo Clinical Use
Published TGA Internet site for information only, effective: 15 July 2009
EMEA/CHMP/BMWP/118264/2007 (pdf,63kb)
Guideline on Non-Clinical and Clinical Development of Similar Biological Medicinal Products Containing Low-Molecular-Weight Heparins
Published: TGA Internet site
Effective: 5 August 2009
EMEA/CHMP/BMWP/170734/2008 (pdf,31kb)
Concept Paper on the Revision of the Guidance on Similar Biological Medicinal Products Containing Recombinant Erythropoietins
Published TGA Internet site for information only, effective: 27 January 2009
Note: EMEA/CHMP/BHWP/94526/2005 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
EMEA/CHMP/BMWP/632613/2009 (pdf,52kb)
Concept Paper on Development of a Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies
Published TGA Internet site for information only, effective: 26 March 2010
Special populations guidelines
pp. 169 - 174 of Rules 1998 (3C) - 3CC9a (pdf,34kb)
Clinical Investigation of Medicinal Products in Geriatrics
Replaces: CPMP/ICH/379/95 (Adopted as III/3388/93 by TGA 1/1/1995) and pp. 147 - 152 of Rules 1989
Effective: 12 February 2002
CPMP/ICH/2711/99 (pdf,119kb)
Note for Guidance on Clinical Investigation of Medicinal Products in the Paediatric Population
Published: TGA Internet site
Effective: 19 April 2001
Vaccines
CHMP/VWP/164653/2005 (pdf,103kb)
Guideline on Clinical Evaluation of New Vaccines
Published: TGA Internet site
Effective: 6 January 2009
CHMP/VWP/263499/2006(pdf,195kb)
Guideline on Influenza Vaccines Prepared from Viruses with the Potential to cause a Pandemic and Intended for Use Outside of the Core Dossier Context
Published: TGA Internet site
Effective: 23 October 2008
EMEA/359381/2009 Rev 1.1 (pdf,144kb)
CHMP Recommendations for the Pharmacovigilance Plan as Part of the Risk Management Plan to be Submitted with the Marketing Authorisation Application for a Pandemic Influenza Vaccine
Published: TGA Internet site
Effective: 26 March 2010
The European Agency for the Evaluation of Medicinal Products (EMEA)