Multidisciplinary guidelines

13 January 2017

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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.

Paediatrics

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EMEA/536810/2008 (pdf,170kb)
Guideline on the Investigation of Medicinal Products in the Term and Preterm Neonate
Effective: 28 May 2010

EMEA/CHMP/PhVWP/235910/2005 - rev.1 (pdf,82kb)
Guideline on Conduct of Pharmacovigilance for Medicines Used by the Pediatric Population
Replaces: EMEA/CHMP/PhVWP/235910/2005 (adopted by TGA 16 March 2009)
Effective 21 July 2014

EMEA/CHMP/PEG/194810/2005 (pdf,197kb)
Reflection Paper: Formulations of Choice for the Paediatric Population
For information: 29 June 2009

Cell therapy and tissue engineering

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EMA/CHMP/BWP/271475/2006 rev.1 (pdf,130kb)
Guideline on potency testing of cell based immunotherapy medicinal products for the treatment of cancer
Replaces: CHMP/BWP/271475/2006 Guideline on Potency Testing of Cell Based Immunotherapy Medicinal Products for the Treatment of Cancer (Adopted by TGA 29 June 2009)
Effective: 6 January 2017

EMEA/CHMP/CPWP/83508/2009 (pdf,123kb)
Guideline on Xenogeneic Cell-based Medicinal Products
Effective: 5 November 2010

TGA annotation:
Sponsors should refer to the prevailing TGA requirements for minimising the risk of transmitting transmissible spongiform encephalopathies: 'Transmissible Spongiform Encephalopathies (TSE): TGA approach to minimising the risk of exposure'.

EMEA/CHMP/410869/2006 (pdf,400kb)
Guideline on Human Cell-Based Medicinal Products
Effective: 5 November 2010

EMA/CAT/573420/2009 (pdf,93kb)
Reflection paper on clinical aspects related to tissue engineered products
Provided for information: 1 September 2015

Vaccines

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EMEA/CPMP/VEG/4717/2003 Rev.1 (pdf,145kb)
Guideline on Dossier Structure and Content for Pandemic Influenza Vaccine Marketing Authorisation Application (Revision)
Replaces: CPMP/VEG/4717/03 (Adopted by TGA 16 August 2004)
Effective: 1 April 2014

TGA annotation:
Section 1.1.2. Pandemic variation
If the pandemic influenza virus is of a HN subtype for which nonclinical and clinical data have not been included in the Core Pandemic Dossier, it is highly desirable that nonclinical and clinical data obtained from studies with the pandemic HN subtype be included in the pandemic variation dossier.
Section 3.1.1
Candidate influenza vaccine virus should be taken to include the most recently available candidates and technologies, as noted on WHO website.

Effective 1 November 2014: the Quality aspects of this Guideline are replaced by EMA/CHMP/BWP/310834/2012 Guideline on Influenza Vaccines - Quality Module.
The nonclinical and clinical aspects of this Guidelines continue to apply.

EMEA/CHMP/VWP/164653/2005 (pdf,102kb)
Guideline on Clinical Evaluation of New Vaccines
Replaces: CPMP/EWP/463/97 Note for Guidance on Clinical Evaluation of New Vaccines (Adopted by TGA 6 February 2002)
Effective: 6 January 2009

TGA annotation:
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

CHMP/VWP/263499/06 (pdf,200kb)
Guideline on Influenza Vaccines Prepared from Viruses with the Potential to cause a Pandemic and Intended for Use Outside of the Core Dossier Context
Effective: 23 October 2008

TGA annotation:
Effective 1 November 2014: the Quality aspects of this Guideline are replaced by EMA/CHMP/BWP/310834/2012 Guideline on Influenza Vaccines - Quality Module.
The nonclinical and clinical aspects of this Guidelines continue to apply.

EMEA/CHMP/VEG/134716/2004 (pdf,187kb)
Guideline on Adjuvants in Vaccines for Human Use
Effective: July 2005

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

CPMP/BWP/214/96 (pdf,109kb)
Harmonisation of Requirements for Influenza Vaccines
Replaces: III/3188/91 (Adopted by TGA July 1994)
Effective: 12 February 2002

TGA annotation:
Effective 1 November 2014: the Quality aspects of this Guideline are replaced by EMA/CHMP/BWP/310834/2012 Guideline on Influenza Vaccines - Quality Module.
The nonclinical and clinical aspects of this Guidelines continue to apply.

CPMP/BWP/2490/00 (pdf,177kb)
Cell Culture Inactivated Influenza Vaccines - Annex to Note for Guidance on Harmonisation of Requirements for Influenza Vaccines CPMP/BWP/214/96
Effective: 5 March 2003

TGA annotation:
Effective 1 November 2014: the Quality aspects of this Guideline are replaced by EMA/CHMP/BWP/310834/2012 Guideline on Influenza Vaccines - Quality Module.
The nonclinical and clinical aspects of this Guidelines continue to apply.

Biosimilars

Overarching biosimilar guidelines

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CHMP/437/04 Rev. 1 (pdf,120kb)
Guideline on similar biological medicinal products.
Replaces: CHMP/437/04 (adopted by TGA 15 June 2006).
Effective: 25 May 2015

EMEA/CHMP/BMWP/42832/2005 Rev1 (pdf,165kb)
Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
Replaces: EMEA/CHMP/BMWP/42832/2005 (adopted by TGA Sept 2006)
Effective: 1 July 2015

EMA/CHMP/BWP/247713/2012 (pdf,140kb)
Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)
Replaces: EMEA/CHMP/BWP/49348/2005. Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Quality Issues. (Adopted by TGA December 2006)
Effective: 1 December 2014

TGA annotation:
Sponsors should also refer to TGA Guidance on the Evaluation of biosimilars

Product-specific biosimilar guidelines

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EMA/CHMP/BMWP/671292/2010 (pdf,107kb)
Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle stimulating hormone (r-hFSH)
Effective: 17 August 2015

EMA/CHMP/BMWP/652000/2010 (pdf,146kb)
Guideline on similar biological medicinal products containing interferon beta
Effective: 17 August 2015

EMA/CHMP/BMWP/403543/2010 (pdf,212kb)
Guideline on similar biological medicinal products containing monoclonal antibodies - non-clinical and clinical issues
In place of: concept paper EMEA/CHMP/BMWP/632613/2009 (provided for information 26 March 2010)
Effective: 17 August 2015

TGA annotation
Sponsors should also refer to TGA Guidance on the Evaluation of biosimilars

EMEA/CHMP/BMWP/301636/2008 Corr.* (pdf,133kb)
Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins
Replaces: EMEA/CHMP/BMWP/94526/2005 corr Annex Guideline on Similar Biological Medicinal Products (adopted by TGA 29 September 2006) and EMEA/CHMP/BMWP/170734/2008 Concept Paper on this topic (provided for information January 2009)
Effective: 3 July 2015

TGA annotation:
Demonstration of efficacy in renal anaemia will support extrapolation to other indications of the reference medicinal product with the same route of administration. It is recommended that potential safety issues in different populations be addressed by conducting clinical studies in the different populations (e.g. renal anaemia and cancer patients).

EMEA/CHMP/BMWP/118264/2007 (pdf,63kb)
Guideline on Non-Clinical and Clinical Development of Similar Biological Medicinal Products Containing Low-Molecular-Weight Heparins
Effective: 5 August 2009

EMEA/CHMP/BMWP/102046/2006 (pdf,97kb)
Reflection Paper on Non-clinical and Clinical Development of Similar Medicinal Products Containing Recombinant Interferon Alfa
Effective: 17 December 2010

EMEA/CHMP/BMWP/31329/2005 (pdf,88kb)
Annex to Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues - Guidance on Similar Biological Medicinal Products Containing Recombinant Granulocyte-Colony Stimulating Factor
Effective: 29 September 2006

EMEA/CHMP/BMWP/94528/2005 (pdf,78kb)
Annex to 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
Effective: 29 September 2006

EMEA/CHMP/BMWP/32775/2005 Rev. 1 (pdf,143kb)
Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues
Replaces: EMEA/CHMP/BMWP/32775/2005
Annex to 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 (Adopted by TGA 12 September 2006)
Effective: 1 September 2015

Other guidelines relevant for biosimilars

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EMEA/CHMP/BMWP/101695/2006 (pdf,118kb)
Guideline on Comparability of Biotechnology-Derived Medicinal Products after a change in the Manufacturing Process - Non-Clinical and Clinical Issues
Replaces: EMEA/CPMP/3097/02 (Adopted by TGA 12 May 2005)
Effective: 8 April 2009

EMEA/CHMP/BMWP/14327/2006 (pdf,167kb)
Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins
Effective: 22 June 2009

EMA/CHMP/BMWP/86289/2010 (pdf,183kb)
Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use
In place of: concept paper EMEA/CHMP/BMWP/114720/2009 on this topic (provided for information 15 July 2009)
Effective: 1 June 2014

CPMP/ICH/5721/03 (pdf,196kb)
ICH Topic Q 5 E: Comparability of Biotechnological/ Biological Products
Note for Guidance on Biotechnological/Biological Products Subject to Changes in their Manufacturing Process

Replaces: EMEA/CPMP/BWP/3207/00, rev 1 (Adopted TGA May 2005)
Effective: 26 March 2010

Gene therapy

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EMEA/CHMP/ICH/607698/2008 (pdf,54kb)
ICH Considerations. Oncolytic Viruses
Effective: 28 May 2010

EMEA/CHMP/GTWP/125459/2006 (pdf,68kb)
Guideline on the Non-Clinical Studies required before First Clinical Use of Gene Therapy Medicinal Products
Effective: 8 April 2009

EMEA/273974/2005 (pdf,113kb)
Guideline on Non-Clinical Testing for Inadvertent Germline Transmission of Gene Transfer Vectors
Effective: 1 May 2009

CPMP/BWP/3088/99 (pdf,127kb)
Note for Guidance on the Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products
Effective: 7 May 2003

TGA annotation:
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.

Pharmacogenomics

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EMA/CHMP/281371/2013 (pdf,228kb)
Guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products.
Effective: 10 November 2016

TGA annotation:
Where applicable, reference to parts of the EU SPC should correspond to the analogous section of the Australian Product Information.

EMA/CHMP/37646/2009 (pdf,166kb)
Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products
Effective: 15 September 2014

EMEA/CHMP/ICH/437986/2006 (pdf,49kb)
ICH Topic E15
Note for Guidance on Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories

Effective: 25 February 2009

EMEA/CHMP/PGxWP/201914/2006 (pdf,57kb)
Reflection Paper on Pharmacogenomic Samples, Testing and Data Handling
Effective: 29 June 2009

Miscellaneous

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EMA/CPMP/ICH/286/1995 (pdf,263kb)
ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals
Replaces: CPMP/ICH/286/95 Modification. (Adopted by TGA 17 December 2010)
Effective: 1 June 2014

EMA/CHMP/ICH/507008/2011 (pdf,210kb)
ICH guideline M3 (R2) - questions and answers
For information: 1 June 2014

CPMP/SWP/5199/02 (pdf,56kb)
EMEA/CHMP/QWP/251344/2006
Guideline on the Limits of Genotoxic Impurities

Effective: November 2006

CPMP/EWP/QWP/1401/98 Rev. 1/ Corr ** (pdf,233kb)
Guideline on the Investigation of Bioequivalence
Replaces: CPMP/QWP/EWP/1401/98
Effective: 16 June 2011

TGA annotation:
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.

EMEA/CHMP/BWP/304831/2007 (pdf,90kb)
Guideline on Allergen Products: Production and Quality Issues
Replaces CPMP/BWP/243/96
Effective: 29 June 2009

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

3CC29a (pdf,52kb)
Investigation of Chiral Active Substances
Replaces: III/3501/91 (Adopted 1 January 1995)
Effective: 12 February 2002

EMA/CHMP/ICH/83812/2013 (pdf,77kb)
ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
Effective: January 2016