European Union guidelines replaced or superseded (previously published as adopted in Australia)
For current adopted guidelines see: EU guidelines ADOPTED in Australia
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 Superseded by the Australian Regulatory Guidelines for Prescription Medicines (ARGPM)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
pp. 3 - 10 of Rules 1989
Development Pharmaceutics and Process Validation
Published: AGRD, effective: July 1994
Status: Replaced by pp. 3 - 10 of Rules 1998 (3A) - 3AQ1a
pp. 11 - 20 of Rules 1989
Chemistry of Active Ingredients
Published: AGRD July 1994
Status: Replaced by pp. 31 - 38 of Rules 1998 (3A) - 3AQ5a
pp. 21 - 30 of Rules 1989
Stability Tests on Active Ingredients and Finished Products
Published: AGRD effective: July 1994
Status: Replaced by pp. 143 - 151 of Rules 1998 (3A) - 3AQ16a
pp. 31 - 37 of Rules 1989
Quality of Herbal Remedies
Published: AGRD July 1994
Status: Replaced by pp. 195 - 202 of Rules 1998 (3A) - 3AQ22a
pp. 39 - 52 of Rules 1989
Production and Quality Control of Medicinal
Products Derived by Recombinant DNA Technology
Published: AGRD 1994, Replaced by III/3477/92 (Revision 1994) in April 1996
Status: Replaced by pp. 205 - 216 of Rules 1998 (3A) - 3AB1a
pp. 73 - 88 of Rules 1989
Pre-clinical Biological Safety Testing of Medicinal Products Derived from Biotechnology
Published: AGRD July 1994
Status: Replaced by CPMP/ICH/302/95 (Adopted by TGA September 1999)
pp. 89 - 90 of Rules 1989
Single-dose Toxicity
Published: AGRD, effective: July 1994
Status: Replaced by pp. 3 - 8 of Rules 1998 (3B) - 3BS1a
pp. 91 - 98 of Rules 1989
Repeated Dose Toxicity
Published: AGRD July 1994
Status: Replaced by CPMP/SWP/1042/99 (Adopted by TGA 23 February 2001) and
CPMP/ICH/300/95 (Adopted by TGA 30 August 2001 - with amendment)
pp. 99 - 101 of Rules 1989
Reproduction Studies
Published: AGRD July 1994, replaced by III/3387/93 in AGRD, effective 1/1/1995
Status: Replaced by pp. 25 - 44 of Rules 1998 (3B) - 3BS4a and CPMP/ICH/136/95 Mod (Adopted by TGA 19 April 2001)
pp. 103 - 105 of Rules 1989
Testing of Medicinal Products for Their Mutagenic Potential
Published: AGRD, effective: July 1994
Status: Replaced by pp. 47 - 50 of Rules 1998 (3B) - 3BS5a and pp. 51 - 62 of Rules 1998 (3B) - 3BS6a also CPMP/ICH/174/95 (Adopted by TGA December 1998)
pp. 107 - 112 of Rules 1989
Carcinogenic Potential
Published: AGRD July 1994
Status: Replaced by pp. 63 - 72 of Rules 1998 (3B) - 3BS7a and pp. 79 - 88 of Rules 1998 (3B) - 3BS9a (previously known as CPMP/ICH/383/95) and CPMP/ICH/299/95 (Adopted by TGA April 2000) and CPMP/ICH/140/95 (Adopted by TGA December 1998) and CPMP/ICH/366/96 (Adopted by TGA Jan 2000) (Addendum to CPMP/ICH/383/95)
pp. 113 - 114 of Rules 1989
Pharmacokinetics and Metabolic Studies in the Safety Evaluation of New Drugs in Animals
Published: AGRD July 1994
Status: Replaced by pp. 103 - 106 of Rules 1998 (3B) - 3BS11a
pp. 115 - 132 of Rules 1989
Recommended Basis for the Conduct of Clinical Trials of Medicinal Products in the European Community
Published: AGRD, later incorporated into pp. 57 - 98 Rules Addendum - July 1990
Status: Replaced by CPMP/ICH/135/95 (Adopted by the TGA (with comments) in August 2000)
pp. 133 - 145 of Rules 1989
Clinical Investigation of Medicinal Products in Children
Published: AGRD effective: July 1994
Status: Replaced by CPMP/ICH/2711/99 (Adopted by the TGA 19 April 2001)
pp. 147 - 152 of Rules 1989
Clinical Investigation of Medicinal Products in the Elderly
Published: AGRD July 1994, Replaced by III/3388/93, published in AGRD 1 January 1995
Status: Replaced by pp. 169 - 174 of Rules 1998 (3C) - 3CC9a
pp. 153 - 157 of Rules 1989
Pharmacokinetic Studies in Man
Published: AGRD, effective: July 1994
Status: Replaced by pp. 99 - 106 of Rules 1998 (3C) - 3CC3a
pp. 159 - 161 of Rules 1989
Investigation of Bioavailability
Published: AGRD 1994, replaced by III/54/89 in Rules Add. No 2 pp. 149 -168, May 1992 and pp. 231 - 244 of Rules 1998 (3C) - 3CC15a
Status: Replaced by CPMP/EWP/QWP/1401/98 (Adopted with notation by TGA 12 February 2002)
pp. 163 - 165 of Rules 1989
Clinical Testing Requirements for Drugs for Long-term Use
Published: AGRD, effective: July 1994
Status: Replaced by pp. 127 - 132 of Rules 1998 (3C) - 3CC6a
Refers also to pp. 121 - 125 of Rules 1998 (3C) - 3CC5a (Adopted by TGA with conditions)
pp. 167 - 168 of Rules 1989
Fixed Combination Products
Published: AGRD 1994, then replaced by CPMP/EWP/240/95 in December 1998
Status: Replaced by pp. 175 - 180 of Rules 1998 (3C) - 3CC10a
pp. 169 - 171 of Rules 1989
Clinical Investigation of Oral Contraceptives
Published: AGRD, effective: July 1994
Status: Replaced by pp. 341 - 346 of Rules 1998 (3C) - 3CC25a
pp. 173 - 174 of Rules 1989
Clinical Investigation of Drugs for the Treatment of Chronic Peripheral Arterial Diseases
Published: AGRD 1994, Replaced by CPMP/EWP/233/95 in August 1997
Status: Replaced by pp. 247 - 256 of Rules 1998 (3C) - 3CC16a
pp. 175 - 176 of Rules 1989
Non-steroidal Anti-inflammatory Compounds for the Treatment of Chronic Disorders
Published: AGRD, effective: July 1994
Status: Replaced by pp. 257 - 261 of Rules 1998 (3C) - 3CC17a
pp. 177 - 179 of Rules 1989
Anti-epileptic/Anti-convulsant Drugs
Published: AGRD 1994, Replaced by pp. 135 - 146 of Rules Addendum
Status: Replaced by CPMP/EWP/566/98 Rev 1 (Adopted by TGA 19 April 2001)
pp. 181 - 186 of Rules 1989
Corticosteroids Intended for Use on the Skin
Published: AGRD, effective: July 1994
Status: Replaced by pp. 347 - 357 of Rules 1998 (3C) - 3CC26a
pp. 187 - 190 of Rules 1989
Anti-anginal Drugs
Published: AGRD 1994, Replaced by CPMP/EWP/234/95 in August 1997
Status: Replaced by pp. 289 - 296 of Rules 1998 (3C) - 3CC20a
pp. 191 - 198 of Rules 1989
Medicinal Products in the Treatment of Cardiac Failure
Published: AGRD 1994, Replaced by CPMP/EWP/235/95 in August 1997
Status: Replaced by CPMP/EWP/235/95 Rev 1 (Adopted by TGA 23 February 2001)
pp. 199 - 207 of Rules 1989
Antiarrhythmic Medicinal Products
Published: AGRD 1994, Replaced by CPMP/EWP/237/95 in August 1997
Status: Replaced by pp. 297 - 306 of Rules 1998 (3C) - 3CC21a
pp. 209 -217 of Rules 1989
Antidepressant Medicinal Products
Published: AGRD, effective: July 1994
Status: Replaced by pp. 307 - 313 of Rules 1998 (3C) - 3CC22a
pp. 1 - 16 of Rules Addendum
Analytical Validation
Published: AGRD 1994, Replaced by III/5626/94 in April 1996
Status: Replaced by pp. 107 - 117 of Rules 1998 (3A) - 3AQ13a and pp. 119 - 125 of Rules 1998 (3A) - 3AQ14a
pp. 17 - 22 of Rules Addendum
European Drug Master File for Active Ingredients
Published: AGRD July 1994
Status: Replaced by pp. 47 - 56 of Rules 1998 (3A) - 3AQ7a
pp. 23 - 40 of Rules Addendum
Production and Quality Control of Cytokine Products Derived by Biotechnological Processes
Published: AGRD July 1994
Status: Replaced by pp. 223 - 235 of Rules 1998 (3A) - 3AB3a
pp. 41 - 55 of Rules Addendum
Production and Quality Control of Human Monoclonal Antibodies
Published: AGRD 1994, Replaced by III/5271/94 in April 1996
Status: Replaced by pp. 237 - 261 of Rules 1998 (3A) - 3AB4a
pp. 57 - 98 of Rules Addendum
Good Clinical Practice for Trials on Medicinal Products in the European Community
Published: AGRD, effective: July 1994
Status: Replaced by CPMP/ICH/135/95 (Adopted by TGA (with comments) August 2000).
pp. 99 - 115 of Rules Addendum
Clinical Testing of Prolonged Action Forms with Special Reference to Extended Release Forms
Published: AGRD, effective: July 1994
Status: Replaced by pp.181 - 192 of Rules 1998 (3C) - 3CC11a
pp. 117 - 133 of Rules Addendum
Evaluation of Anticancer Medicinal Products in Man
Published: AGRD, effective: July 1994
Status: Replaced by CPMP/EWP/205/95 Rev 1 Corr (Adopted by TGA 10 January 2002)
pp. 135 - 146 of Rules Addendum
Medicinal Products for the Treatment of Epileptic Disorders (Revision)
Published: AGRD, effective: July 1994
Status: Replaced by CPMP/EWP/566/98 Rev 1 (Adopted by TGA 19 April 2001)
pp. 3 - 10 of Rules 1998 (3A) - 3AQ1a
Development Pharmaceutics and Process Validation
Replaces: pp. 3 - 10 of Rules 1989
Status: Replaced by CPMP/QWP/155/96 (Adopted by TGA 1 May 2000) and CPMP/QWP/848/96 (Adopted by TGA 27 March 2002)
pp. 19 - 22 of Rules 1998 (3A) - 3AQ3a
Limitations to the Use of Ethylene Oxide in the Manufacture of Medicinal Products
Replaces: III/9261/90 (Adopted by TGA 1 January 1995)
Status: Replaced by CPMP/QWP/159/01 (Adopted by TGA 22 May 2002)
pp. 31 - 38 of Rules 1998 (3A) - 3AQ5a
Chemistry of Active Substances
Replaces: pp. 11 - 20 of Rules 1989
Status: Replaced by CPMP/QWP/130/96, Rev 1 (Adopted by TGA 24 August 2004)
pp. 39 - 45 of Rules 1998 (3A) - 3AQ6a
Requirements in Relation to Active Substances
Published: TGA Internet Site, effective 12 February 2002, replacing: III/8315/89 (Adopted by TGA July 1994)
Status: Replaced by CPMP/QWP/297/97 (Published as effective 13 February 2003)
pp. 47 - 56 of Rules 1998 (3A) - 3AQ7a
European Drug Master File Procedure for Active Substances
Published: Replaced pp.17 - 22 of Rules Addendum (effective 12 February 2002)
Status: This guideline has been replaced in Europe by CPMP/QWP/227/02 which has been Not Adopted by the TGA. The TGA requirements and procedures for Drug Master Files are set out in Appendix 11 of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM).
pp. 57-66 of Rules 1998 (3A) - 3AQ8a
Impurities in New Active Substances
Status: Replaced by CPMP/ICH/2737/99 (Effective 12 March 2003)
pp.75-82 of Rules 1998 (3A) - 3AQ10a
Plastic Primary Packaging Materials
Published: Replaced III/9090/90 (Adopted by TGA 1 January 1995)
Status: Replaced by CPMP/QWP/4359/03 (Adopted by TGA, effective 1 December 2005)
pp. 83 - 94 of Rules 1998 (3A) - 3AQ11a
Specifications and Control Tests on the Finished Product
Replaces: III/3324/89 (Adopted by TGA July 1994)
Status: Replaced by CPMP/ICH/367/96 corr (Adopted by TGA 29 June 2001)
pp. 95 - 105 of Rules 1998 (3A) - 3AQ12a
Impurities in New Medicinal Products
Published: TGA website, effective 12 February 2002
Status: Replaced by CPMP/ICH/2738/99 (Effective 16 August 2004)
pp. 127 - 141 of Rules 1998 (3A) - 3AQ15a
Stability Testing of New Active Substances and Medicinal Products
Status: Replaced by CPMP/ICH/2736/99 (Adopted by TGA 19 April 2001)
pp. 143 - 151 of Rules 1998 (3A) - 3AQ16a
Stability Testing on Active Ingredients and Finished Products
Replaces: pp. 21 - 30 of Rules 1989
Status: Replaced by CPMP/QWP/556/96 (Adopted by TGA 1 May 2000)
pp. 167 - 174 of Rules 1998 (3A) - 3AQ19a
Quality of Prolonged Release Oral Solid Dosage Forms
Status: Replaced by CPMP/QWP/604/96 (Adopted by TGA 19 April 2001)
pp. 195 - 202 of Rules 1998 (3A) - 3AQ22a
Quality of Herbal Remedies
Published: with effect from 12 February 2002, Replaces: pp. 31 - 37 of Rules 1989
Status: "For information on the requirements for Listed and Registered complementary medicines sponsors should refer to Complementary Medicines on the TGA website. For additional information contact the TGA's Office of Complementary Medicines (OCM)."
Published: 12 February 2003
pp. 107 - 116 of Rules 1998 (3B) - 3BS12a
Non-Clinical Local Tolerance Testing of Medicinal Products
Status: Replaced by CPMP/SWP/2145/00 (Adopted by TGA 10 January 2002 - with conditions)
pp. 231 - 244 of Rules 1998 (3C) - 3CC15a
Investigation of Bioavailability and Bioequivalence
Replaces: III/54/89 (Adopted by TGA July 1994), pp. 149 - 168 of Rules Add. No 2 and pp. 159 - 161 of Rules 1989
Status: Replaced by CPMP/EWP/QWP/1401/98 (Adopted with notation by TGA 12 February 2002)
pp. 181 - 192 of Rules 1998 (3C) - 3CC11a
Clinical Testing of Prolonged Action Forms with Special Reference to Extended Release Forms
Replaces: pp. 99 - 115 of Rules Addendum
Status: Replaced by CPMP/EWP/280/96 (Adopted by TGA 14 March 2001)
pp. 247 - 256 of Rules 1998 (3C) - 3CC16a
Medicinal Products in the Treatment of Chronic Peripheral Arterial Occlusive Disease
Published: with effect from 12 February 2002
Replaces: pp. 173 - 174 of Rules 1989 and CPMP/EWP/233/95 (Adopted by TGA August 1997)
Status: Replaced by CPMP/EWP/714/98 Rev 1 (Adopted by TGA 7 May 2003)
pp. 289 - 296 of Rules 1998 (3C) - 3CC20a
Clinical Investigation of Anti-Anginal Medicinal Products in Stable Angina Pectoris
Published: TGA Internet site, effective: 12 February 2002
Status: Replaced by CPMP/EWP/234/95 Rev 1 (Adopted by TGA 29 September 2006)
pp. 307 - 313 of Rules 1998 (3C) - 3CC22a
Medicinal Products for the Treatment of Depression
Published: TGA Internet site, effective: 12 February 2002
Status: Replaced by CPMP/EWP/518/97 Rev 1 - Published as effective 7 August 2002
pp. 315 - 331 of Rules 1998 (3C) - 3CC23a
Evaluation of Anticancer Medicinal Products in Man
Status: Replaced by CPMP/EWP/205/95 Rev 1 Corr (Adopted by TGA 10 January 2002)
pp. 371 - 380 of Rules 1998 (3C) - 3CC28a
Clinical Investigation of Medical Products in the Treatment of Generalised Anxiety Disorder, Panic Disorder and Obsessive-Compulsive Disorder
Replaced: III/3673/92 (Adopted by TGA April 1996, with conditions)
Published: 12 February 2002
Adopted by TGA with the following conditions:
Sponsors of drugs for this purpose in Australia are asked to take into account Australian clinical practice in this area, particularly with regard to the:
- Duration of studies, given that panic disorder and obsessive-compulsive disorder are long-term illnesses;
- Sample size of clinical trials; and
- Measurement scales used to assess efficacy; objective outcome measures should be considered wherever available.
Status: Replaced by CHMP/EWP/4279/02, CHMP/EWP/4280/02, and CPMP/EWP/4284/02 (Published as effective July 2005)
Volume 2B - Presentation and Content of the Dossier Notice to Applicants of the Rules Governing Medicinal Products in the European Community
Published: TGA Internet site
Effective: 19 April 2001
Adopted by the TGA with the following notation:
"Note that the administrative details in these rules do not apply in Australia"
Status: Replaced by the Common Technical Document (CTD) Format (Adopted by TGA October 2002)
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 on TGA Internet site 19 April 2001
Status: Replaced by CPMP/BPWG/198/95 Rev 1, Note for Guidance on the Clinical Investigation of Human Plasma Derived Factor VIII and IX Products
CPMP/BWP/243/96
Revised Note for Guidance on Allergen Products
Published: TGA News (Replaces III/9271/90)
Content: This guideline is the same as pp. 373 - 380 of Rules 1998 (3A) - 3AB15a
Effective: August 1997
CPMP/BWP/268/95
Note for Guidance on Virus Validation Studies: The Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses
Published: TGA News August 1997, effective: August 1997
Status: Replaced by pp. 295 - 309 of Rules 1998 (3A) - 3AB8a
CPMP/BWP/269/95 Rev 1
Note for Guidance on Plasma Derived Medicinal Products
Published: TGA News August 1997
Status: Replaced by CPMP/BWP/269/95 Rev 2 18 April 2001 and CPMP/BWP/269/95 Rev 3 on 30 August 2001
CPMP/BWP/1230/98 Revision
Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products
Published: TGA News April 2000, with effect from 1 May 2000
Status: Replaced by EMEA/410/01 Rev 1 (Adopted by TGA 20 December 2002)
EMEA/CPMP/BWP/3207/00
Note for Guidance on Comparability of Medicinal Products containing Biotechnology-Derived Proteins as Drug Substance
Published: TGA Internet site, effective: 23 October 2002
Status: Replaced by EMEA/CPMP/BWP/3207/00, rev 1 (Adopted by TGA 2 May 2005)
CPMP/EWP/021/97
Points To Consider on Hormone Replacement Therapy
Published: TGA Internet site 15 December 2000
Status: Replaced by EMEA/CHMP/021/97 Rev 1 (Adopted by TGA 9 February 2006)
CPMP/EWP/504/97
Points to Consider On Clinical Investigations of Medicinal Products in the Treatment of Patients with Acute Respiratory Distress Syndrome
Published: TGA Internet site 19 April 2001
Status: Replaced by EMEA/CPMP/EWP/504/97 Rev 1 (Adopted by TGA 7 October 2008
CPMP/EWP/205/95 Rev 1 Corr
Note for Guidance on Evaluation of Anticancer Medicinal Products in Man
Published: TGA Internet site, effective: 10 January 2002
Status: Replaced by CPMP/EWP/205/95 Rev 2 corr (Adopted by TGA 15 September 2005)
Status: Replaced by EMEA/EWP/205/95 Rev 3 corr (Adopted by TGA June 2006)
CPMP/EWP/233/95
Note for Guidance on the Clinical Investigation of Medicinal Products in the Treatment of Chronic Peripheral Arterial Occlusive Disease
Published: TGA News August 1997, effective: August 1997
Status: Replaced by pp. 247 - 256 of Rules 1998 (3C) - 3CC16a
CPMP/EWP/234/95
Note for Guidance on the Clinical Investigation of Anti-Anginal Medicinal Products in Stable Angina Pectoris
Published: TGA News August 1997, effective: August 1997
Status: Replaced by pp. 289 - 296 of Rules 1998 (3C) - 3CC20a
CPMP/EWP/235/95
Note for Guidance on the Clinical Investigation of Medicinal Products in the Treatment of Cardiac Failure
Published: TGA News August 1997
Status: Replaced by CPMP/EWP/235/95 Rev 1 - Published TGA Internet site 23 February 2001
CPMP/EWP/237/95
Note for Guidance on Antiarrhythmics
Published: TGA News August 1997, effective: August 1997
Status: Replaced by pp. 297 - 306 of Rules 1998 (3C) - 3CC21a
CPMP/EWP/238/95 Rev 1
Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Hypertension
Published: TGA Internet site, effective: March 2004
Status: Replaced by CPMP/EWP/238/95 Rev 2 (Adopted by TGA 15 June 2006)
CPMP/EWP/239/95
Note for Guidance on the Clinical Requirements for Locally Applied, Locally Acting Products containing Known Constituents
Published: TGA News August 1997, effective: August 1997
Status: Replaced by pp. 193 - 198 of Rules 1998 (3C) - 3CC12a
CPMP/EWP/240/95
Note for Guidance on Fixed Combination Medicinal Products
Published: TGA News, effective: December 1998
Status: Replaced by pp. 175 - 180 of Rules 1998 (3C) - 3CC10a
CPMP/EWP/462/95
Note for Guidance on Clinical Investigation of Medicinal Products in Children
Published: TGA Internet Site
Status: Replaced by CPMP/ICH/2711/99 15 December 2000
CPMP/EWP/519/98
Note for Guidance on Clinical Investigation of Steroid Contraceptives in Women
Published: TGA Internet site April 2001
Status: Replaced by EMEA/CPMP/EWP/519/98 rev 1 (Published as effective January 2006)
CPMP/EWP/552/95 Rev 1
Note for Guidance on Postmenopausal Osteoporosis in Women
Published: TGA Internet site 30 August 2001
Status: Replaced by CPMP/EWP/552/95 Rev 2 (Published as effective 7 August 2008)
CPMP/EWP/555/95
Note for Guidance on Clinical trials with Haematopoietic Growth factors for the Prophylaxis of Infection following Myelosuppressive or Myeloablative Therapy
Published: TGA News April 2000 (with conditions), effective: 1 May 2000
Status: Replaced by pp. 333 - 340 of Rules 1998 (3C) - 3CC24a
Comments: This Note for Guidance is generally acceptable but flexibility will be used in:
(i) the nature of the patient population in a Phase I trial
(ii) analysing different types of infections in neutropenic patients and
(iii) the sample size - this may be determined by the expected incidence of neutropenic fever rather than culture-proven infections.
CPMP/EWP/556/95
Points to Consider on Clinical Investigation of Slow-acting Anti-Rheumatic Medicinal Products in Rheumatoid Arthritis
Published: TGA Internet site 23 February 2001
Status: Replaced by CPMP/EWP/556/95 Rev 1 (Adopted by the TGA January 2007)
CPMP/EWP/602/95
Points to Consider in the Assessment of Anti-HIV Medicinal Products
Published: TGA News August 1997
Status: Replaced by CPMP/EWP/602/95 Rev.1 Published TGA Internet site 13/02/2001 and then by CPMP/602/95 Rev 3 (EWP) (Adopted by TGA 27 March 2002)
CPMP/EWP/602/95 Rev 1
Points to Consider in the Assessment of Anti-HIV Medicinal Products
Published: TGA Internet Site, effective: 13 February 2001
Amendment: "This amendment principally concerns surrogate markers used for approval under Exceptional circumstances (Article 13(2) of Council Regulation No 2309/93). There are no legislated "exceptional circumstances" provisions in Australia. Therefore, only the scientific principles for assessment in the revised guideline are adopted."
Status: Replaced by CPMP/602/95 Rev 3 (EWP) (Adopted with amendment by the TGA 27 March 2002)
EMEA/CHMP/EWP/5872/03
Guideline on Data Monitoring Committees
Published: TGA Internet site
Effective: January 2006
Status: Replaced by EMEA/CHMP/EWP/5872/03 corr (Adopted by the TGA 23 March 2006)
CPMP/602/95 Rev 3
Points to Consider on the Assessment of Anti-HIV Medicinal Products
Published: with effect from 27 March 2002
Replaces: CPMP/EWP/602/95 Rev 1
Adopted by the TGA with the following notation:
"It should be noted that while this guideline refers to approval under Exceptional circumstances (Article 13(2) of Council Regulation No 2309/93), there are no legislated "exceptional circumstances" provisions in Australia."
Status: Replaced by CPMP/EWP/633/02 (Adopted with amendment by the TGA 25 February 2004)
CPMP/EWP/633/02
Note for Guidance on the Clinical Development of Medicinal Products for the Treatment of HIV Infection
Published: TGA Internet site, effective: March 2004
Replaced by: CPMP/EWP/633/02 Rev 1 (Adopted by TGA 15 June 2006)
CPMP/ICH/136/95
Note for Guidance on Reproductive Toxicology: Toxicity on Male Fertility
Published: TGA News December 1998
Status: Replaced by CPMP/ICH/136/95 Mod (Adopted by TGA 19 April 2001)
CPMP/ICH/136/95 Mod
Note for Guidance on Reproductive Toxicology: Toxicity on Male Fertility (Addendum to CPMP/ICH/386/95 Note for Guidance on Reproductive Technology: Detection of Toxicity to reproduction for Medicinal Products)
Addendum to: CPMP/ICH/386/95 (Adopted by TGA as III/3387/93 1/1/95)
Effective: 19 April 2001
Status: Replaced by pp. 25 - 44 of Rules 1998 (3B) - 3BS4a
CPMP/ICH/138/95
Note for Guidance on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
Published: TGA News April 2000, effective: 1 May 2000
Status: Replaced by pp. 263 - 273 of Rules 1998 (3A) - 3AB5a
CPMP/ICH/139/95
Note for Guidance on Quality of Biotechnological Products: Analysis of the Expression Construct in Cell Lines used for Production of r-DNA Derived Protein Products
Published: TGA News April 2000, effective: 1 May 2000
Status: Replaced by pp. 217 - 222 of Rules 1998 (3A) - 3AB2a
CPMP/ICH/140/95
Note for Guidance on the Need for Carcinogenicity Studies of Pharmaceuticals
Published: TGA News effective December 1998
Status: Replaced by pp. 73 - 78 of Rules 1998 (3B) - 3BS8a
CPMP/ICH/141/95
Note for Guidance on Genotoxicity: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals
Published: TGA News September 1999, effective: 1 October 1999
Status: Replaced by pp. 51 - 62 of Rules 1998 (3B) - 3BS6a
CPMP/ICH/142/95
Note for Guidance on Impurities Testing: Impurities in New Drug Substances
Published: TGA News August 1997
Status: Replaced by pp. 57 - 66 of Rules 1998 (3A) - 3AQ8a
CPMP/ICH/279/95
Note for Guidance on the Photostability Testing of New Active Substances and Medicinal Products
Published: TGA News September 1999, effective: 1 October 1999
Status: Replaced by pp. 157 - 166 of Rules 1998 (3A) - 3AQ18a
CPMP/ICH/280/95
Note for Guidance on Stability Testing: Requirements for New Dosage Forms
Published: TGA News September 1999, effective: 1 October 1999
Status: Replaced by pp.153 - 155 of Rules 1998 (3A) - 3AQ17a and refers also to pp.143 - 151 of Rules 1998 (3A) - 3AQ16a
CPMP/ICH/281/95
Note for Guidance on Validation of Analytical Procedures: Methodology
Published: TGA Internet Site,
effective: 23 February 2001
Status: Replaced by pp. 107 - 117 of Rules 1998 (3A) - 3AQ13a
CPMP/ICH/282/95
Note for Guidance on Impurities in New Medicinal Products
Published: TGA Internet Site 13 February 2001
Status: Replaced by CPMP/ICH/2736/99
CPMP/ICH/375/95
Note for Guidance on Population Exposure: The Extent of Population Exposure to Assess Clinical Safety
Published: TGA News April 1996 as III/5084/94 (with conditions), effective: April 1996
Status: Replaced by pp. 121 - 125 of Rules 1998 (3C) - 3CC5a - Adopted by TGA with the following conditions: (also refers to pp.127 - 132 of Rules 1998 3C - 3CC6a)
Conditions: While the DSEB has supported the adoption of this Guideline, 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.
CPMP/ICH/379/95
Note for Guidance on Studies in Support of Special Populations: Geriatrics
Published: AGRD as III/3388/93, effective: 1 January 1995
Status: Replaced by pp. 169 - 174 of Rules 1998 (3C) - 3CC9a
CPMP/ICH/380/95
Note for Guidance on Stability Testing: Stability Testing of New Drug Substances and Products
Published: AGRD as III/3335/92, effective: 1 January 1998
Status: Replaced by CPMP/ICH/2736/99 (Adopted by TGA 19 April 2001)
CPMP/ICH/386/95
Note for Guidance on Reproductive Toxicology: Detection of Toxicity to Reproduction for Medicinal Products
Published: AGRD as III/3387/93, effective: 1 January 1995
Status: Replaced by pp. 25 - 44 of Rules 1998 (3B) - 3BS4a and CPMP/ICH/136/95 Mod (Adopted by TGA 19 April 2001)
CPMP/ICH/381/95
Note for Guidance on Validation of Analytical Methods: Definitions and Terminology
Published: TGA News April 1996 as III/5626/94, effective: April 1996
Status: Replaced by pp. 119 - 125 of Rules 1998 (3A) - 3AQ14a
CPMP/ICH/384/95
Note for Guidance on Toxicokinetics: A Guidance for Assessing Systemic Exposure in Toxicology Studies
Published: TGA News April 1996 as III/5081/94
Status: Replaced by pp. 89 - 101 of Rules 1998 (3B) - 3BS10a
CPMP/ICH/385/95
Note for Guidance on Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies
Published: TGA News April 1996 as III/5082/94, effective: April 1996
Status: Replaced by pp. 21 - 24 of Rules 1998 (3B) - 3BS3a
CPMP/ICH/2736/99
Note for Guidance on Stability Testing of New Drug Substances and Products (Revision of CPMP/ICH/380/95)
Replaces: pp. 127 - 141 of Rules 1998 (3A) - 3AQ15a and CPMP/ICH/380/95 (Adopted by TGA as III/3335/92)
Published: TGA Internet site,
effective: 19 April 2001
Status: Replaced by CPMP/ICH/2736/99 Revision 2 (Q1A)
CPMP/QWP/157/96
Reduced Stability Testing Plan - Bracketing and Matrixing: Annex to Note for Guidance on Stability Testing of New Drug Substances and Products (CPMP/ICH/380/95)
Published: TGA News, effective 1 May 2000
Status: Replaced by CPMP/ICH/4104/00 (Adopted by TGA 7 May 2003)
CPMP/QWP/297/97
Note for Guidance on Summary of Requirements for Active Substances in PART II of the Dossier
Replaces: pp. 39 - 45 of Rules 1998 (3A) - 3AQ6a (published as effective 12 February 2002)
Previously published: as NOT Adopted 15 December 2000
Published: 12 February 2003
Status: Replaced by CHMP/QWP/297/97 Rev 1 corr (published as effective January 2006)
CPMP/QWP/486/95
Note for Guidance on the Manufacture of the Finished Dosage Form
Published: TGA News April 2000, effective: 1 May 2000
Status: Replaced by pp. 11 - 18 of Rules 1998 (3A) - 3AQ2a
CPMP/QWP/556/96
Note for Guidance on Stability Testing of Existing Active Substances & Related Finished Products
Published: TGA News April 2000
Previously published as Rules 1998 (3AQ12a)
Status: Replaced by CPMP/QWP/122/02, rev 1 (Adopted by TGA 16 June 2004)
CPMP/SWP/2599/02
Position Paper on Non-Clinical Safety Studies to Support Clinical Trials with a Single Microdose
Published: TGA Internet site, effective: 17 September 2004
Status: Replaced by CPMP/SWP/2599/02, rev 1 (Adopted by TGA 2 May 2005)
EMEA/410/01 Rev 1
Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products
Published: TGA Internet site, effective: 20 December 2002
Status: Replaced by EMEA/410/01 Rev 2 (Adopted by TGA 20 September 2005)
III/54/89
Investigation of Bioavailability and Bioequivalence
Published: AGRD, July 1994, replaced by pp. 231 - 244 of Rules 1998 (3C) - 3CC15a
Status: Replaced by CPMP/EWP/QWP/1401/98 (Adopted with notation by TGA 12 February 2002)
III/3008/93
Note For Guidance: Control Authority Batch Release of Coagulation Factor Concentrates
Published: TGA Internet Site, with effect from 15 December 2000
Status: Replaced by EDQM OCABR # 02 - 2001 (Adopted by TGA 6 November 2002)
III/3009/93
Control Authority Batch Release of Albumin
Published: TGA Internet Site, with effect from 15 December 2000
Status: Replaced by EDQM OCABR # 03 - 2001 (Adopted by TGA 6 November 2002)
III/3010/93
Control Authority Batch Release of Human Normal Immunoglobulin
Published: TGA Internet Site, with effect from 15 December 2000
Status: Replaced by EDQM OCABR # 04 - 2001 (Adopted by TGA 6 November 2002)
III/3036/91
Definition of a New Active Substance
Published: AGRD
Effective: 1 January 1993
Adopted by the TGA with the following notation:
"Sponsors should consider all references to 'the European Community' to be replaced by 'Australia'."
Status: Replaced by the definition of "New Chemical Entity" in Schedule 9 of the Therapeutic Goods Regulations 1990
III/3085/93
Control Authority Batch Release of: Rubella Vaccine; Mumps Vaccine; Combined Measles, Mumps and Rubella Vaccine;
Published: AGRD, effective: 1 January 1995
Status: Replaced by EDQM OCABR guideline #30 - Mumps Vaccine (Published as Not Adopted 22 May 2002) and EDQM OCABR guidelines # 35 - Rubella Vaccine and #27 - Combined MMR Vaccines (Published as effective 7 February 2003)
III/3004/91
Manufacture of Investigational Medicinal Products
Published: TGA Internet Site
Status: Replaced by Annex 13 of Volume 4 of the Eudralex Guidelines - Adopted in Australia with effect from 15 September 1999
III/3172/91
Quality of Prolonged Release Oral Solid Dosage Forms
Published: AGRD, effective: 1 January 1995
Status: Replaced by CPMP/QWP/604/96 (Adopted by TGA 19 April 2001)
III/3188/91
Harmonization of Requirements for Influenza Vaccines
Published: AGRD, effective: July 1994
Status: Replaced by pp. 355 - 372 of Rules 1998 (3A) - 3AB14a
III/3193/91 Rev 2
Control Authority Batch Release of Measles Vaccines
Published: TGA Internet Site, effective: 10 January 2002
Status: Replaced by EDQM OCABR guideline #28 - Measles Vaccine (Published as effective 7 February 2003)
III/3196/91
Excipients in the Dossier for Application for Marketing Authorization of a Medicinal Product
Published: AGRD with effect 1 January 1995
Status: Replaced by pp. 67 - 74 of Rules 1998 (3A)- 3AQ9a
III/3298/91
Minimizing the Risk of Transmitting Agents Causing Spongiform Encephalopathy Via Medicinal Products
Published: AGRD
Status: Replaced by CPMP/BWP/1230/98 Rev. Published TGA News April 2000
III/3324/89
Specifications and Control Tests on the Finished Product
Published: AGRD with effect July 1994
Status: Replaced by pp. 83 - 94 of Rules 1998 (3A) - 3AQ11a
III/3335/92
Stability Testing of New Drug Substances and Products
Published: AGRD, effective: 1 January 1998
Status: Replaced by CPMP/ICH/2736/99 (Adopted by TGA 19 April 2001)
III/3387/93
Detection of Toxicity to Reproduction for Medicinal Products
Published: AGRD, effective: 1 January 1995
Status: Replaced by pp. 25 - 44 of Rules 1998 (3B) - 3BS4a and CPMP/ICH/136/95 Mod (Adopted by TGA 19 April 2001)
III/3388/93 aka CPMP/ICH/379/95
Studies in Support of Special Populations: Geriatrics
Published: AGRD, effective: 1 January 1995
Status: Replaced by pp. 169 - 174 of Rules 1998 (3C) - 3CC9a
III/3477/92 (Revision 1994)
Production and Quality Control of Medicinal Products Derived by Recombinant DNA Technology
Published: TGA News April 1996, effective: April 1996
Status: Replaced by pp. 205 - 216 of Rules 1998 (3A) - 3AB1a
III/3487/89
Radiopharmaceuticals Based on Monoclonal Antibodies
Published: AGRD July 1994
Status: Replaced by pp. 185 - 194 of Rules 1998 (3A) - 3AQ21a
III/3501/91
Investigation of Chiral Active Substances
Published: AGRD, effective: 1 January 1995
Status: Replaced by pp. 381 - 391 of Rules 1998 (3C) - 3CC29a
III/3561/91
Adaptation of Pharmaceutical Export Report to Radiopharmaceuticals
Published: AGRD with effect from 1 January 1995
Status: As this guideline refers specifically to a format which is not consistent with the Common Technical Document (CTD) format, it is no longer considered relevant in Australia.
Published: 17 September 2002
III/3612/93
Use of Transgenic Animals in the Manufacture of Biological Medicinal Products for Human Use
Published: TGA News April 1996, effective: April 1996
Status: Replaced by pp. 287 - 294 of Rules 1998 (3A) - 3AB7a
III/3630/92
Biostatistical Methodology in Clinical Trials in Applications for Marketing Authorisations for Medicinal Products
Published: TGA News April 1996, effective: April 1996
Status: Replaced by CPMP/ICH/363/96 (Adopted by TGA, effective 1 October 1999)
III/3673/92
Clinical Investigation of Medicinal Products in the Treatment of Anxiety Disorders
Published: TGA News April 1996 (with conditions), effective: April 1996
Status: Replaced by pp. 371 - 380 of Rules 1998 (3C) - 3CC28a
Conditions: This Guideline is to be adopted. However, intending Sponsors for drugs for this purpose in Australia are asked to take into account Australian clinical practice in this area, particularly with regard to the:
(i) Duration of studies, given that panic disorder and obsessive-compulsive disorder are long-term illnesses;
(ii) Sample size of clinical trials; and
(iii) Measurement scales used to assess efficacy; objective outcome measures should be considered wherever available.
III/3855/89
Clinical Investigation of Hypnotic Medicinal Products
Published: AGRD, effective: July 1994
Status: Replaced by pp. 359 - 370 of Rules 1998 (3C) - 3CC27a
III/3936/89
Radiopharmaceuticals
Published: AGRD July 1994
Status: Replaced by pp. 175 - 184 of Rules 1998 (3A) - 3AQ20a
III/3979/88
Non-clinical Local Tolerance Testing of Medicinal Products
Published: AGRD, effective: July 1994
Status: Replaced by CPMP/SWP/2145/00 (Adopted by TGA 10 January 2002 - with conditions)
III/5081/94
Toxicokinetics: A Guidance for Assessing Systemic Exposure in Toxicology Studies
Published: TGA News April 1996
Status: Replaced by pp. 89 - 101 of Rules 1998 (3B) - 3BS10a
III/5082/94
Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies
Published: TGA News April 1996 (aka CPMP/ICH/385/95)
Status: Replaced by pp. 21 - 24 of Rules 1998 (3B) - 3BS3a
III/5083/94
Dose Selection for Carcinogenicity Studies of Pharmaceuticals
Published: TGA News April 1996
Status: Replaced by pp. 79 - 88 of Rules 1998 (3B) - 3BS9a
III/5084/94
The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-term Treatment of Non-life Threatening Conditions
Published: TGA News April 1996 (with conditions), effective: April 1996
Status: Replaced by pp. 121 - 125 of Rules 1998 (3C) - 3CC5a - Adopted by TGA with the following same conditions: (also refers to pp.127 - 132 of Rules 1998 3C - 3CC6a )
Conditions: While the DSEB has supported the adoption of this Guideline, 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.
III/5193/94
Note For Guidance on Plasma Pool Testing
Published: TGA Internet Site, effective: 15 December 2000
Status: Replaced by pp. 351 - 353 of Rules 1998 (3A) - 3AB13a and CPMP/BWP/269/95 Rev 3 (Adopted by TGA 30 August 2001)
III/5271/94
Production and Quality Control of Monoclonal Antibodies
Published: TGA News April 1996, effective: April 1996
Status: Replaced by pp. 237 - 261 of Rules 1998 (3A) - 3AB4a
III/5378/93
Replacement of Chlorofluorocarbons (CFCs) in Metered Dose Inhalation Products
Published: AGRD, effective: 1 January 1995
Status: Replaced by pp. 153 - 163 of Rules 1998 (3B) - 3BR3a
III/5543/94
Validation of Virus Removal/Inactivation Procedure: Choice of Viruses
Published: TGA Internet Site, effective: 15 December 2000
Status: Replaced by pp. 311 - 313 of Rules 1998 (3A) - 3AB9a
III/5626/94
Validation of Analytical Methods: Definitions and Terminology
Published: TGA News April 1996, effective: April 1996
Status: Replaced by pp. 119 - 125 of Rules 1998 (3A) - 3AQ14a
III/5830/93
Blood Products and Non-Enveloped Viruses
Published: TGA Internet Site 15 December 2000
Status: Replaced by CPMP/BWP/269/95 Rev 3 (Adopted by TGA 30 August 2001)
III/5863/93
Gene Therapy Products -- Quality Aspects in the Production of Vectors and Genetically Modified Somatic Cells
Published: TGA News April 1996, effective: April 1996
Status: Replaced by pp. 275 - 286 of Rules 1998 (3A) - 3AB6a
III/8115/89
Validation of Virus Removal and Inactivation Procedures
Published: AGRD 1994, Replaced by CPMP/BWP/268/95 Adopted by TGA August 1997
Status: Replaced by pp. 295 - 313 of Rules 1998 (3A) - 3AB8a and 3AB9a
III/8315/89
Requirements in Relation to Active Substances
Published: AGRD July 1994
Status: Replaced by pp. 39 - 45 of Rules 1998 (3A) - 3AQ6a
III/8379/89
Medicinal Products Derived from Human Blood and Plasma
Published: AGRD
Status: Replaced by CPMP/BWP/269/95 in August 1997 and CPMP/BWP/269/95 Rev 3 30 August 2001
III/9090/90
Plastic Primary Packaging Materials
Published: AGRD with effect 1 January 1995
Status: Replaced by pp. 75 - 82 of Rules 1998 (3A) - 3AQ10a
III/9109/90
The Use of Ionizing Radiation in the Manufacture of Medicinal Products
Published: AGRD July 1994
Status: Replaced by pp. 23 - 30 of Rules 1998 (3A) - 3AQ4a
III/9261/90
Limitations to the Use of Ethylene Oxide in the Manufacture of Medicinal Products
Published: AGRD, effective: 1 January 1995
Status: Replaced by pp. 19 - 30 of Rules 1998 (3A) - 3AQ3a
III/9271/90
Allergen Products
Published: AGRD
Status: Replaced by CPMP/BWP/243/96 in August 1997 (same as pp. 373 - 380 Rules 1998 (3A) - 3AB15a)
The European Agency for the Evaluation of Medicinal Products (EMEA)