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Quality guidelines

European Union guidelines adopted in Australia

27 February 2014

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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.

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 Superseded by the Australian Regulatory Guidelines for Prescription Medicines (ARGPM)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

Active substances

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pp. 157 - 166 of Rules 1998 (3A) - 3AQ18a (pdf,51kb)
Photostability Testing of New Active Substances and Medicinal Products
Replaces: CPMP/ICH/279/95 (Adopted by TGA 1 October 1999)
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/QWP/227/02 Rev 1 (pdf,191kb)
Guideline on active substance master file procedure
Published: TGA Internet site
Effective: 1 June 2013
Adopted by TGA with the following notation:

"EU-specific procedural requirements stated in this Guideline do not apply in Australia."

CHMP/QWP/297/97 Rev 1 corr (pdf,235kb)
Guideline on summary of requirements for Active Substances in the quality part of the dossier
Replaces: CHMP/QWP/297/97 (Published as effective 12 February 2003) which previously replaced pp. 39 - 45 of Rules 1998 (3A) - 3AQ6a (published as effective 12 February 2002)
Published: TGA Internet site
Effective: 4 January 2006
Adopted by the TGA with the following notation:

"The pharmacopoeias of EU member states, other than the British and European Pharmacopoeias (BP and Ph Eur), have no standing in Australia. The official standards in Australia are the British Pharmacopoeia (BP), the European Pharmacopoeia (Ph Eur) and the United States Pharmacopeia-National Formulary (USP).

Additional TGA requirements for active substances, Drug Master Files and Certificates of Suitability are set out in the Australian Regulatory Guidelines for Prescription Medicines (ARGPM)."

CPMP/ICH/283/95 (pdf,246kb)
Note for Guidance on Impurities: Residual Solvents (CPMP/ICH/283/95)
Published: TGA Internet site
Effective: 1 May 2009
Status: See also CPMP/QWP/450/03

EMA/CHMP/ICH/82260/2006 (pdf,247kb)
Impurities: guideline for residual solvents ICHQ3C(R5)
Published: TGA Internet site
Effective: 1 June 2013

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CPMP/ICH/367/96 Corr (pdf,228kb)
Note for Guidance on Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
Published: TGA Internet site
Effective: 29 June 2001

CPMP/ICH/421/02 (pdf,155kb)
Note for Guidance on Stability Data Package for Registration in Climatic Zones III and IV
Published: TGA Internet site
Effective: 17 September 2004
Adopted in Australia, with annotation:

"This guideline has been adopted by the TGA because a significant portion of Australia lies in climatic zones III and IV. The guideline requires at least 12 months stability testing at 30°C/65% rh, 6 months testing at 40°C/75% rh, 3 months testing at 50°C (in certain circumstances) and 3 months testing at 25°C/80% rh (for solid dosage forms in water-vapour permeable packaging). However, the TGA allows some alternatives to these requirements, as follows:

  1. Testing at 50°C is not required.
  2. Testing at 25°C/80% rh is not required if the product shows satisfactory stability during long term testing at 30°C/65% rh.
  3. If a product does not show satisfactory stability for at least 3 months at 40°C/75% rh, there are several acceptable options:
    • argue that, as the container is designed to provide a barrier to water vapour, further investigation of stability under conditions of high humidity is not necessary; or
    • demonstrate, by testing at least 3 batches, that the product is stable for 3-6 months at 30°C/75% rh; or
    • package the product in a container/closure system that is less permeable to water vapour; or
    • label the product "Store below 25°C".
  4. If a product is labelled "Store below 25°C", the TGA will accept:
    • long term stability testing at 25°C/60% rh in place of 30°C/65% rh; and
    • 6 months testing at 25°C/80% rh or 30°C/65% rh (at least 3 batches) in place of 40°C/75% rh. Nevertheless, initial testing of the product should be conducted in accordance with the guideline, ie, at 30°C/65% rh and 40°C/75% rh. If stability is inadequate under these conditions (and, if tested, the alternative condition of 30°C/75% rh) the use of more protective packaging should be considered before the option of labelling the product "Store below 25°C".

Generally, if a product shows satisfactory stability for at least 3 months at a high humidity test condition (40°C/75% rh, 30°C/75% rh, 30°C/65% rh or 25°C/80% rh, as appropriate), then the TGA will consider a shelf life of up to 2 years, subject to satisfactory long term stability data. If a product is stable for 6 months under these conditions then a shelf life in excess of 2 years will be considered. [Any of these four storage conditions would be acceptable for high humidity testing of a product labelled "Store below 25°C", but only 40°C/75% rh or 30°C/75% rh would be acceptable for a product labelled "Store below 30°C".]"

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CPMP/ICH/2737/99 (pdf,187kb)
Note for Guidance on Impurities Testing: Impurities in New Drug Substances (Revision of CPMP/ICH/142/95)
Published: TGA Internet Site
Effective: 12 March 2003

CPMP/ICH/4104/00 (pdf,182kb)
Note for Guidance on Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products
Published: TGA Internet Site
Effective: 7 May 2003

CPMP/QWP/122/02, rev 1 (pdf,222kb)
Guideline on Stability Testing: Stability Testing of Existing Active Substances and Related Finished Products
Replaces: CPMP/QWP/122/02 corr and CPMP/QWP/122/02, which replaced CPMP/QWP/556/96
Published: TGA Internet Site
Effective: 16 June 2004

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CPMP/QWP/130/96 Rev 1 (pdf,206kb)
Guideline on the Chemistry of New Active Substances
Replaces: pp. 31 - 38 of Rules 1998 (3A) - 3AQ5a (published as effective 12 February 2002)
Published: TGA Internet Site
Effective: 24 August 2004

CPMP/QWP/450/03 (pdf,150kb)
Annex 1: Specifications for Class 1 and Class 2 Residual Solvents in active substances
Annex 2: Residues of solvents used in the manufacture of finished products

Published: TGA Internet Site
Effective: 13 January 2005

CPMP/QWP/1529/04 (pdf,150kb)
Guideline on Control of Impurities of Pharmacopoeial Substances: Compliance with the European Pharmacopoeia General Monograph "Substances for Pharmaceutical Use" and General Chapter "Control of Impurities in Substances for Pharmaceutical Use"
Published: TGA Internet site
Effective: 7 October 2004

CPMP/QWP/8567/99 (pdf,23kb)
Operation of Two-Year Transition Period for Application of Note for Guidance on Residual Solvents to Marketed Products
Published: TGA Internet Site (Included in BP 2000)
Effective: 1 December 2000

ICH Q7A
ICH Harmonised Tripartite Guideline - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Published: TGA Internet site
Effective: 29 May 2002
Adopted by the TGA with the following notation:

"This guideline has been adopted as a Manufacturing principle in Australia (MP1/2002). Sponsors should refer to the Determination and the associated notation located on the GMP page of the website."

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Excipients

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EMEA/CHMP/QWP/396951/2006 (pdf,127kb)
Guideline on Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product
Replaces: pp. 67 - 74 of Rules 1998 (3A) - 3AQ9a and CPMP/CVMP/QWP/115/95
Published: TGA Internet site
Effective: 28 May 2010

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General guidelines

III/8113/89
Assessment Reports on Medicinal Products
Published: AGRD
Effective: 1 January 1993

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CPMP/BWP/3354/99 (pdf,209kb)
Note for Guidance on the Production and Quality Control of Animal Immunoglobulins and Immunosera for Human Use
Published: TGA Internet site
Effective: 7 September 2004

CPMP/EWP/QWP/1401/98 Rev 1 (pdf,237kb)
Guideline on the Investigation of Bioequivalence
Replaces: pp. 231 - 244 of Rules 1998 (3C) (Adopted by TGA 12 February 2002)
Replaces: CPMP/QWP/EWP/1401/98 (Adopted by TGA 10 April 2002)
Published: TGA Internet site
Effective: 16 June 2011
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 (i.e., 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."

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CPMP/ICH/420/02 (pdf,265kb)
Note for Guidance on Evaluation of Stability Data
Published: TGA Internet Site
Effective: 24 August 2004

CPMP/QWP/054/98 Corr (pdf,43kb)
Decision Trees for the Selection of Sterilisation Methods (Annex to CPMP/QWP/155/96)
Published: TGA Internet Site
Effective: 15 December 2000

CPMP/QWP/155/96 (pdf,51kb)
Note for Guidance on Development Pharmaceutics
Replaces: pp. 3 - 10 of Rules 1998 (3A) - 3AQ1a
Published: TGA News April 2000
Effective: 1 May 2000

CPMP/QWP/158/01 Revision (pdf,137kb)
Note for Guidance on Quality of Water for Pharmaceutical Use
Published: TGA Internet site
Effective: 30 October 2002
Adopted by the TGA with the following notation:

"In conformity with the Note for Guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients - CPMP/ICH/4106/00 (which was adopted by the TGA as a Manufacturing Principle (MP1/2002) with effect from 29th May 2002), the TGA recommends that for the purposes of compliance with this guideline on water quality, potable water should comply with the latest WHO guidelines for drinking water quality (currently, Guidelines for Drinking-water Quality, 2nd ed., Vol. 2 Health criteria and other supporting information, 1996 (pp. 940-949) and Addendum to Vol. 2, 1998 (pp. 281-283): Geneva, World Health Organization)."

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CPMP/QWP/3309/01 - EMEA/CVMP/961/01 (pdf,191kb)
Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data to be Forwarded in Part II of the Dossier for a Marketing Authorisation
Published: TGA Internet site
Effective: 15 November 2004
Adopted by the TGA with the following notation:

"This Guideline provides useful guidance on the scientific principles and practical use of Near-Infrared (NIR) spectroscopy, and it supplements the technical information provided in the European Pharmacopoeia monograph on NIR spectrophotometry."

EMEA/410/01 Rev 2 (pdf,242kb)
Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products
Published: TGA Internet site
Replaces: EMEA 410/01 Rev 1 (Adopted by TGA 20 December 2002)
Effective: 20 September 2005
Adopted by the TGA with the following notations:

"This EU Guideline replaces EMEA/410/01 Rev 1 (adopted by the TGA 20 December 2002)."

"This EU Guideline should be interpreted in the context of the TGA Policy Document - Supplementary Requirements for Therapeutic Goods for Minimising the Risk of Transmitting Transmissible Spongiform Encephalopathies (TSE's)."

EMEA/CHMP/167068/2004 (pdf,57kb)
Note for Guidance on Pharmaceutical Development
Published: TGA Internet site
Effective: 15 June 2006

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Medicinal products

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pp. 11 - 18 of Rules 1998 (3A) - 3AQ2a (pdf,40kb)
Manufacture of the Finished Dosage Form
Replaces: CPMP/QWP/486/95 (Adopted by TGA 1 May 2000)
Effective: 12 February 2002

pp. 23 - 30 of Rules 1998 (3A) - 3AQ4a (pdf,35kb)
The Use of Ionizing Radiation in the Manufacture of Medicinal Products
Replaces: III/9109/90 (Adopted by TGA July 1994)
Effective: 12 February 2002

pp. 153 - 155 of Rules 1998 (3A) - 3AQ17a (pdf,15kb)
Stability Testing: Requirements for New Dosage Forms
Replaces: CPMP/ICH/280/95 (Adopted by TGA 1 October 1999)
Effective: 12 February 2002

pp. 157 - 166 of Rules 1998 (3A) - 3AQ18a (pdf,51kb)
Photostability Testing of New Active Substances and Medicinal Products
Replaces: CPMP/ICH/279/95 (Adopted by TGA 1 October 1999)
Effective: 12 February 2002

pp. 153 - 163 of Rules 1998 (3B) - 3BR3a (pdf,43kb)
Replacement of Chlorofluorocarbons (CFC) in Metered Dose Inhalation Products
Replaces: III/5378/93 (Adopted by TGA 1 January 1995)
Effective: 12 February 2002

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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/BWP/1793/02 (pdf,191kb)
Note for Guidance on the Use of Bovine Serum in the Manufacture of Human Biological Medicinal Products
Published: TGA Internet site
Effective: 7 September 2004

CPMP/BWP/2517/00 (pdf,39kb)
Points to Consider on the Reduction, Elimination or Substitution of Thiomersal in Vaccines
Published: TGA Internet site
Effective: 10 January 2002

CPMP/BWP/3354/99 (pdf,209kb)
Note for Guidance on the Production and Quality Control of Animal Immunoglobulins and Immunosera for Human Use
Published: TGA Internet site
Effective: 7 September 2004

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EMEA/CPMP/BWP/3794/03 (pdf,659kb)*
Guideline on the Scientific Data Requirements for a Plasma Master File (PMF)
Published: TGA Internet Site
Effective: 18 February 2005

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/4151/00 Rev 1 (pdf,177kb)
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

CPMP/ICH/367/96 Corr (pdf,228kb)
Note for Guidance on Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
Replaces: pp. 83 - 94 of Rules 1998 (3A) - 3AQ11a (published as effective 12 February 2002)
Published: TGA Internet site
Effective: 29 June 2001

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CPMP/ICH/421/02 (pdf,155kb)
Note for Guidance on Stability Data Package for Registration in Climatic Zones III and IV
Published: TGA Internet site
Effective: 17 September 2004
Adopted in Australia, with annotation:

"This guideline has been adopted by the TGA because a significant portion of Australia lies in climatic zones III and IV. The guideline requires at least 12 months stability testing at 30°C/65% rh, 6 months testing at 40°C/75% rh, 3 months testing at 50°C (in certain circumstances) and 3 months testing at 25°C/80% rh (for solid dosage forms in water-vapour permeable packaging). However, the TGA allows some alternatives to these requirements, as follows:

  1. Testing at 50°C is not required.
  2. Testing at 25°C/80% rh is not required if the product shows satisfactory stability during long term testing at 30°C/65% rh.
  3. If a product does not show satisfactory stability for at least 3 months at 40°C/75% rh, there are several acceptable options:
    • argue that, as the container is designed to provide a barrier to water vapour, further investigation of stability under conditions of high humidity is not necessary; or
    • demonstrate, by testing at least 3 batches, that the product is stable for 3-6 months at 30°C/75% rh; or
    • package the product in a container/closure system that is less permeable to water vapour; or
    • label the product "Store below 25°C".
  4. If a product is labelled "Store below 25°C", the TGA will accept:
    • long term stability testing at 25°C/60% rh in place of 30°C/65% rh; and
    • 6 months testing at 25°C/80% rh or 30°C/65% rh (at least 3 batches) in place of 40°C/75% rh. Nevertheless, initial testing of the product should be conducted in accordance with the guideline, ie, at 30°C/65% rh and 40°C/75% rh. If stability is inadequate under these conditions (and, if tested, the alternative condition of 30°C/75% rh) the use of more protective packaging should be considered before the option of labelling the product "Store below 25°C".

Generally, if a product shows satisfactory stability for at least 3 months at a high humidity test condition (40°C/75% rh, 30°C/75% rh, 30°C/65% rh or 25°C/80% rh, as appropriate), then the TGA will consider a shelf life of up to 2 years, subject to satisfactory long term stability data. If a product is stable for 6 months under these conditions then a shelf life in excess of 2 years will be considered. [Any of these four storage conditions would be acceptable for high humidity testing of a product labelled "Store below 25°C", but only 40°C/75% rh or 30°C/75% rh would be acceptable for a product labelled "Store below 30°C".]"

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CPMP/ICH/2736/99 Revision 2 (Q1A) (pdf,259kb)
Stability Testing Guidelines: Stability Testing of New Drug Substances and Products (Revision 2)
Published: TGA Internet Site
Effective: 24 August 2004
Status: Replaces CPMP/ICH/2736/99

CPMP/ICH/2738/99 (pdf,150kb)
Note for Guidance on Impurities in New Drug Products
Published: TGA Internet site
Effective: 1 May 2009
Status: Replaces CPMP/ICH/2736/99-ICH Q3B(R) Adopted by TGA 16 August 2004

CPMP/ICH/4104/00 (pdf,182kb)
Note for Guidance on Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products
Published: TGA Internet Site
Effective: 7 May 2003

CPMP/QWP/072/96 (pdf,21kb)
Note for Guidance on Start of Shelf-life of the Finished Dosage Form (Appendix to NFG on Manufacture of the Finished Dosage Form CPMP/QWP/486/95)
Published: TGA Internet site
Effective: 27 March 2002

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CPMP/QWP/159/01 (pdf,24kb)
Note for Guidance on Limitations to the Use of Ethylene Oxide in the Manufacture of Medicinal Products
Replaces: pp. 19 - 22 of Rules 1998 (3A) - 3AQ3a
Published: TGA Internet Site
Effective: 22 May 2002
Adopted by the TGA with the following notation:

Sponsors should note that the British Pharmacopoeia (BP2001 - pp841) dictates that "the use of ethylene oxide for the decontamination of herbal products is prohibited."

CPMP/QWP/159/96 Corr (pdf,246kb)
Note for Guidance on Maximum Shelf Life for Sterile Products After First Opening or Following Reconstitution (Annex to the Note for Guidance on Stability Testing of New Active substances & Medicinal Products (CPMP/ICH/380/95))
Published: TGA Internet Site
Effective: 23 February 2001
Adopted by the TGA with the following notation:

The allowance ".....unless reconstitution/dilution (etc) has taken place in controlled and validated aseptic conditions" detailed in the section: 'Unpreserved Sterile Products - Specific Text for Preparations for Infusion or Injection.' will only be permitted for products prepared in TGA licensed compounding facilities and in those hospital pharmacies that have been formally audited to the NCCTG standard and SHPA guidelines and have demonstrated that they can provide the appropriate level of sterility assurance.

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CPMP/QWP/450/03 (pdf,150kb)
Annex 1: Specifications for Class 1 and Class 2 Residual Solvents in active substances
Annex 2: Residues of solvents used in the manufacture of finished products

Published: TGA Internet Site
Effective: 13 January 2005

CPMP/QWP/604/96 (pdf,84kb)
Note for Guidance on Quality of Modified Release Products - Section 1 (Quality)
A: Oral Dosage Forms
B: Transdermal Dosage Forms

Replaces: pp. 167 - 174 of Rules 1998 (3A) - 3AQ19a and III/3172/91 (Adopted by TGA 1 January 1995)
Published: TGA Internet site
Effective: 19 April 2001

CPMP/QWP/848/96 (pdf,64kb)
Note for Guidance on Process Validation
Replaces: pp. 3 - 10 of Rules 1998 (3A) - 3AQ1a
Published: TGA Internet site
Effective: 27 March 2002
Adopted by the TGA with the following notation:

"Although the guideline refers (in Section 6: Change Control) to Type I and II Variations and EC Regulations 541/95/EC and 542/95/EC, it should be noted that these legislative requirements are not applicable in Australia. Australian sponsors should therefore refer to Appendix 12 of the ARGPM."

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CPMP/QWP/1529/04 (pdf,150kb)
Guideline on Control of Impurities of Pharmacopoeial Substances: Compliance with the European Pharmacopoeia General Monograph "Substances for Pharmaceutical Use" and General Chapter "Control of Impurities in Substances for Pharmaceutical Use"
Published: TGA Internet site
Effective: 7 October 2004

CPMP/QWP/1719/00 Rev 1 (pdf,102kb)
Guideline on Medicinal Gases: Pharmaceutical Documentation (Including Recommendation on Non-Clinical Safety Requirements for Well Established Medicinal Gases)
Replaces: CPMP/QWP/1719/00 (Adopted by TGA 12 March 2003)
Published: TGA Internet site
Effective: 26 June 2009

CPMP/QWP/2054/03 (pdf,159kb)
Annex II to note for guidance on process validation CHMP/QWP/848/96 and EMEA/CVMP/598/99 non standard processes
Published: TGA Internet Site
Effective: 13 January 2005

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CPMP/QWP/2934/99 (pdf,41kb)
Note for Guidance on In-Use Stability Testing of Human Medicinal Products
Published: TGA Internet site
Effective: 27 March 2002

EMEA/CHMP/QWP/569959/2008 (pdf,47kb)
Concept Paper on the Revision of the Guideline on Parametric Release
Published TGA Internet site for information only, effective: 23 March 2009

CPMP/QWP/3015/99 (pdf,59kb)
Note for Guidance on Parametric Release
Published: TGA Internet site
Effective: 22 May 2002

CPMP/QWP/4359/03 (pdf,181kb)
Guideline on Plastic Immediate Packaging Materials
Replaces: pp.75-82 of Rules 1998 (3A) - 3AQ10a
Published: TGA Internet site
Effective: 1 December 2005

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Radiopharmaceuticals

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III/3700/90
Notice to Applicants: Amendments for Radiopharmaceutical Applications

Published: AGRD
Effective: 1 January 1993

pp. 185 - 194 of Rules 1998 (3A) - 3AQ21a (pdf,50kb)
Radiopharmaceuticals Based on Monoclonal Antibodies
Replaces: III/3487/89 (Adopted by TGA July 1994)
Effective: 12 February 2002

EMEA/CHMP/CVMP/362268/2009 (pdf,44kb)
Concept Paper on the Revision of the Guideline on Radiopharmaceuticals Based on Monoclonal Antibodies
Published TGA Internet site for information only, effective: 26 March 2010

EMEA/CHMP/QWP/306970/2007 (pdf,113kb)
Guideline for Radiopharmaceuticals
Published: TGA Internet site
Effective: 22 June 2009

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Specific types of products

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EMEA/CHMP/QWP/49313/2005 (pdf,250kb)
Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products
Published: TGA Internet site
Effective: 1 October 2006

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Specifications, analytical procedures & analytical validation

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CPMP/ICH/381/95 (pdf,183kb)
Note for Guidance on Validation of Analytical Procedures: Text and Methodology (CPMP/ICH/381/95) Rev 1
Replaces: pp. 107 - 117 of Rules 1998 (3A) - 3AQ13a and pp. 119 - 125 of Rules 1998 (3A) - 3AQ14a (Adopted by TGA 12 February 2002)
Published: TGA Internet site
Effective: 8 April 2009

EMEA/CHMP/ICH/265145/2009 (pdf,113kb)
Questions and Answers on ICH Topics Q8, Q9 and Q10
Note for Guidance on Pharmaceutical Development, Quality Risk Management and Pharmaceutical Quality System

Published: TGA Internet site
Effective: 28 May 2010

EMEA/CHMP/ICH/308895/2008 (pdf,64kb)
ICH Topic Q4B Annex 5
Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test

Published: TGA Internet site
Effective: 28 May 2010

EMEA/CHMP/ICH/379801/2009 (pdf,59kb)
ICH Topic Q4B Annex 9
Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH regions on Tablet Friability

Published: TGA Internet site
Effective: 28 May 2010

EMEA/CHMP/ICH/381133/2009 (pdf,59kb)
ICH Topic Q4B Annex 10
Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH regions on Polyacrylamide Gel Electrophoresis

Published: TGA Internet site
Effective: 28 May 2010

EMA/CHMP/ICH/645469/2008 (pdf,100kb)
ICH guideline Q4B annex 7 (R2) to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on dissolution test. General chapter.
Effective: 24 February 2014
(Replaces EMEA/CHMP/ICH/645469/2008)

EMEA/CHMP/ICH/645592/2008 (pdf,69kb)
ICH Topic Q4B Annex 8
Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test

Published: TGA Internet site
Effective: 28 May 2010

EMA/CHMP/CVMP/QWP/199250/2009 Corr (pdf,427kb)
Guideline on setting specifications for related impurities in antibiotics
Published: TGA Internet site
Effective: 1 June 2013

European Medicines Agency
European Medicines Agency (EMA)

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Web page last updated: Thursday, 27 February 2014

URL: http://www.tga.gov.au/industry/pm-euguidelines-adopted-quality.htm