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European Union guidelines

Please Note:

Where European Union (EU) guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of prescription medicines by the TGA. The Australian legislative requirements applying to prescription medicines are contained in the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990, as well as in various legislative instruments such as Therapeutic Goods Orders, Notices and Determinations, see Legislation <http://www.tga.gov.au/legis/index.htm>

EU guidelines - newly published

The following guidelines have been published in the last 4 months.

Guidelines adopted in the last 4 months

  • EMEA/CHMP/GTWP/607698/2008
    ICH Considerations
    Oncolytic Viruses

    Published: TGA Internet site
    Effective: 28 May 2010
  • EMEA/536810/2008
    Guideline on the Investigation of Medicinal Products in the Term and Preterm Neonate
    Published: TGA Internet site
    Effective: 28 May 2010
  • EMEA/CHMP/EWP/356954/2008
    Guideline on the Clinical Investigations of Medicinal Products for the Treatment of Pulmonary Arterial Hypertension
    Published: TGA Internet site
    Effective: 28 May 2010
  • EMEA/CHMP/EWP/30039/2008
    Guideline on the Clinical Evaluation of Direct Acting Antiviral Agents Intended for Treatment of Chronic Hepatitis C
    Published: TGA Internet site
    Effective: 28 May 2010
  • EMEA/CHMP/EWP/321180/2008
    Appendix 1 to the Guideline on Clinical Evaluation of Diagnostic Agents (CPMP/EWP/1119/98 Rev. 1) on Imaging Agents
    Published: TGA Internet site
    Effective: 28 May 2010
  • CPMP/EWP/1119/98 Rev.1
    Clinical Evaluation of Diagnostic Agents
    Replaces: CPMP/EWP/1119/98
    Published: TGA Internet site
    Effective: 28 May 2010
  • EMEA/CHMP/QWP/396951/2006
    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
  • EMEA/CHMP/ICH/381133/2009
    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
  • EMEA/CHMP/ICH/379801/2009
    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/645592/2008
    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
  • EMEA/CHMP/ICH/645469/2008
    ICH Topic Q4B Annex 7
    Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH regions on Dissolution Test

    Published: TGA Internet site
    Effective: 28 May 2010
  • EMEA/CHMP/ICH/308895/2008
    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/265145/2009
    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/BWP/452081/2007
    Guideline on the Replacement of Rabbit Pyrogen Testing by an Alternative Test for Plasma-derived Medicinal Products
    Published: TGA Internet site
    Effective: 28 May 2010
  • CPMP/EWP/240/95 Rev. 1
    Guideline on Clinical Development of Fixed Combination Medicinal Products
    Replaces: pp. 175 - 180 of Rules 1998 (3C) - 3CC10a
    Published: TGA Internet site
    Effective: 28 May 2010
  • EMEA/CHMP/BMWP/632613/2009
    Concept Paper on Development of a Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies
    Published: TGA Internet site
    Effective: 26 March 2010
  • CPMP/ICH/5721/03
    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)
    Published: TGA Internet site
    Effective: 26 March 2010
  • CPMP/EWP/281/96 Rev.1
    Guideline on Clinical Evaluation of Medicinal Products Used in Weight Control
    Replaces: CPMP/EWP/281/96
    Published: TGA Internet site
    Effective: 26 March 2010
    Adopted by the TGA with the following conditions:
    • "If a sponsor wishes to claim secondary benefits associated with weight loss (such as improved blood lipids, glycaemic control or blood pressure), then the relevant guidelines for these specific benefits should be independently satisfied"
  • EMEA/359381/2009 Rev 1.1
    CHMP Recommendations for the Pharmacovigilance Plan as Part of the Risk Management Plan to be Submitted with the Marketing Authorisation Application for a Pandemic Influenza Vaccine
    Published: TGA Internet site
    Effective: 26 March 2010
  • EMEA/CHMP/EWP/604040/2009
    Concept Paper on the Need for a Guideline on the Clinical Investigation of Medicinal Products Intended for Treatment of Systematic and Cutaneous Lupus Erythematosus
    Published: TGA Internet site
    Effective: 26 March 2010
  • EMEA/CHMP/EWP/350495/2009
    Concept Paper on the Need to Update the Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Lipid Disorders (CPMP/EWP/3020/03) and the Note for Guidance on the Clinical Investigation on Medicinal Products in the Treatment of Hypertension (CPMP/EWP/238/95 REV. 2) to Discuss the Need for Outcome Studies Basis on Safety Data at the Time of MAA.
    Published: TGA Internet site
    Effective: 26 March 2010
  • EMEA/CHMP/CVMP/362268/2009
    Concept Paper on the Revision of the Guideline on Radiopharmaceuticals Based on Monoclonal Antibodies
    Published: TGA Internet site
    Effective: 26 March 2010
  • EMEA/CHMP/BWP/134153/2009
    Concept Paper on the Need to Revise the Guideline on the Use of Transgenic Animals in the Manufacture of Biological Medicinal Products for Human Use (3AB7A of July 1995)
    Published: TGA Internet site
    Effective: 26 March 2010
  • EMEA/CHMP/EWP/484366/2009
    Concept Paper on the Need for Revision of Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Depression with Regard to Treatment Resistant Depression
    Published: TGA Internet site
    Effective: 23 February 2010
  • EMEA/CHMP/EWP/358650/2006 Corr 2*
    Guideline on the Development of Medicinal Products for the Treatment of Post-Traumatic Stress Disorder (PTSD)
    * The correction includes minor wording changes in Sections 1 and 4, an additional sentence at the end of General Recommendations under the heading Clinical Safety Evaluation of Section 4 and the additional sentence 'Alternatively, if different types of patients are included in the same trials then randomization should take place with strata defined by type of onset.' in pages 5 and 6.
    Published: TGA Internet site
    Effective: 23 February 2010
  • CPMP/EWP/4891/03
    Guideline on Clinical Investigation of Medicinal Products for the Treatment of Ankylosing Spondylitis
    Published: TGA Internet site
    Effective: 23 February 2010
  • CPMP/EWP/4151/00 Rev 1
    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
    Published: TGA Internet site
    Effective: 23 February 2010
  • Full list of EU guidelines ADOPTED in Australia

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Guidelines replaced/superseded in the last 4 months

  • CPMP/EWP/1119/98
    Points To Consider on the Evaluation of Diagnostic Agents

    Published: TGA Internet site 27 March 2002
    Status: Replaced by CPMP/EWP/1119/98 Rev.1 (Adopted by TGA 28 May 2010)
  • CPMP/CVMP/QWP/115/95
    Note for Guidance on the Inclusion of Antioxidants and Antimicrobial Preservatives in Medicinal products

    Published: TGA Internet site 19 April 2001
    Status: Replaced by EMEA/CHMP/QWP/396951/2006 (Adopted by TGA 28 May 2010)
  • pp. 67 - 74 of Rules 1998 (3A) - 3AQ9a
    Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product

    Published: TGA Internet site 12 February 2002
    Status: Replaced by EMEA/CHMP/QWP/396951/2006 (Adopted by TGA 28 May 2010)
  • pp. 175 - 180 of Rules 1998 (3C) - 3CC10a
    Fixed-Combination Medicinal Products

    Published: TGA Internet site 12 February 2002
    Status: Replaced by CPMP/EWP/240/95 Rev. 1 (Adopted by TGA 28 May 2010)
  • EMEA/CPMP/BWP/3207/00, rev 1
    Guideline on Comparability of Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues

    Published: TGA Internet site
    Effective: 2 May 2005
    Status: Replaced by CPMP/ICH/5721/03 (Adopted by TGA 26 March 2010)
  • CPMP/EWP/281/96
    Note for Guidance on Clinical Drugs Used in Weight Control

    Published: TGA News October 2000, effective 1 August 2000
    Status: Replaced by CPMP/EWP/281/96 Rev.1 (Adopted by TGA 26 March 2010)
  • CHMP/EWP/358650/2006
    Guideline on the Development of Medicinal Products for the Treatment of Post-Traumatic Stress Disorder (PTSD)

    Published: TGA Internet site 8 April 2009
    Status: Replaced by EMEA/CHMP/EWP/358650/2006 Corr 2 (Adopted by TGA 23 February 2010)
  • CPMP/EWP/4151/00
    Points to consider on the requirements for clinical documentation for orally inhaled products (OIP)
    Published: TGA Internet site 13 January 2005
    Status: Replaced by CPMP/EWP/4151/00 Rev 1 (Adopted by TGA 23 February 2010)
  • Full list of EU guidelines REPLACED/SUPERSEDED in Australia

Guidelines NOT adopted in the last 4 months

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