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 Superseded by the Australian Regulatory Guidelines for Prescription Medicines (ARGPM)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
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"
CPMP/EWP/633/02 Rev 1 (pdf,100kb)
Guideline on the Clinical Development of Medicinal Products for the Treatment of HIV Infection
Published: TGA Internet site
Replaces: CPMP/EWP/633/02 (Adopted by TGA February 2004, which replaced CPMP/602/95 Rev 3)
Effective: 15 June 2006
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/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/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 (pdf,39kb)
Note for Guidance on the Clinical Investigation of Human Anti-D Immunoglobulin for Intravenous and / or Intramuscular Use
Published: TGA Internet site
Effective: 19 April 2001
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
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
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 (pdf,42kb)
Points To Consider on Clinical Investigation of Medicinal Products for Prophylaxis of Intra- and Post-Operative Venous Thromboembolic Risk
Published: TGA Internet site
Effective: 25 January 2001
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
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
Central 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
CHMP/EWP/252/03 (pdf,216kb)
Guideline on clinical investigation of medicinal products intended for the treatment of neuropathic pain
Published: TGA Internet site
Effective: 1 June 2005
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 (pdf,70kb)
Note for Guidance on Medicinal Products in the Treatment of Alzheimer's Disease
Published: TGA News April 2000
Effective: 1 May 2000
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 (pdf,100kb)
Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Multiple Sclerosis
Published: TGA Internet site
Effective: 10 January 2002
CPMP/EWP/563/95 (pdf,68kb)
Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Parkinson's Disease
Published: TGA News April 2000
Effective: 1 May 2000
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 (pdf,191kb)
Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Migraine
Published: TGA Internet site
Effective: 20 May 2005
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 (Published as effective 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 (Published as effective 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 (Published as effective 12 February 2002)
Effective: July 2005
Clinical pharmacology 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
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."
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
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 in Australia 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
Clinical safety guidelines
Appendix 20 - AGRM
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. 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,133kb)
Note for Guidance on Planning Pharmacovigilance Activities
Published: TGA Internet site
Effective: 10 August 2005
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
CPMP/EWP/281/96 (pdf,52kb)
Note for Guidance on Clinical Drugs Used in Weight Control
Published: TGA News October 2000
Effective: 1 August 2000
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 (published as effective 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
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. 175 - 180 of Rules 1998 (3C) - 3CC10a (pdf,31kb)
Fixed-Combination Medicinal Products
Replaces: pp. 167 - 168 of Rules 1989 and
CPMP/EWP/240/95 (Adopted by TGA December 1998)
Effective: 12 February 2002
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/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 (pdf,82kb)
Points To Consider on the Evaluation of Diagnostic Agents
Published: TGA Internet site
Effective: 27 March 2002
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/83561/2005 (pdf,63kb)
Guideline on Clinical Trials in Small Populations
Published: TGA Internet site
Effective: December 2006
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
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
pp. 333 - 340 of Rules 1998 (3C) - 3CC24a (pdf,37kb)
Clinical trials with Haematopoietic Growth Factors for the Prophylaxis of Infection following Myelosuppressive or Myeloablative Therapy
Replaces: CPMP/EWP/555/95 (Adopted by TGA 1 May 2000, with conditions)
Effective: 12 February 2002
Adopted by TGA with the following notation:
Flexibility will be used in:
- the nature of the patient population in a Phase I trial
- analysing different types of infections in neutropenic patients and
- the sample size - this may be determined by the expected incidence of neutropenic fever rather than culture-proven infections.
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
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."
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.
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.
CPMP/EWP/788/01 (pdf,191kb)
Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Migraine
Published: TGA Internet site
Effective: 20 May 2005
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
CPMP/EWP/4151/00 (pdf,160kb)
Points to consider on the requirements for clinical documentation for orally inhaled products (OIP)
Published: TGA Internet site
Effective: 13 January 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
CPMP/EWP/2284/99 (pdf,45kb)
Points to Consider on Clinical Investigation of Medicinal Products used for the Management of Crohn's Disease
Published: TGA Internet site
Effective: 10 January 2002
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
Respiratory system guidelines
CPMP/EWP/504/97 (pdf,42kb)
Points to Consider On Clinical Investigations of Medicinal Products in the Treatment of Patients with Acute Respiratory Distress Syndrome
Published: TGA Internet site
Effective: 19 April 2001
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
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
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
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
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/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
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
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
EMEA/CHMP/EWP/147013/2004 (pdf,110kb)
Guideline on the Role of Pharmacokinetics in the Development of Medicinal Products in the Paediatric Population
Published: TGA Internet site
Effective: November 2006
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
The European Agency for the Evaluation of Medicinal Products (EMEA)