Consultations on adoption of European Union guidelines in Australia: Outcome of previous consultation

13 January 2017

Following consultation within the TGA and with relevant external stakeholders including Industry and Consumer groups, ending 5 January 2017, the following EU/ICH guidelines have been adopted by the TGA, effective 6 January 2017 unless indicated otherwise:

Clinical efficacy and safety guidelines

Clinical pharmacology and pharmacokinetics

  • EMA/CHMP/594085/2015
    Guideline on the use of pharmacokinetics and pharmacodynamics in the development of antimicrobial medicinal products
    Replaces: CHMP/EWP/225/02 Note for guidance on the evaluation of the Pharmacokinetics of medicinal products in patients with impaired renal function; and EMA/CHMP/203926/2012. Concept paper on the need for revision of the Note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function.
    Effective: 1 Feburary 2017

Product-specific bioequivalence guidance*

The European Medicines Agency's (EMA) has published a series of finalised product-specific bioequivalence guidelines which summarise in a standardised format the relevant study design principles for the demonstration of bioequivalence for specific products.

Unless specified otherwise, the TGA accepts these product specific requirements for bioequivalence demonstration described in finalised guidelines on this page:

The TGA effective date of the individual guidance is the effective date of the individual guidance.

For those products which comply with the current non-product-specific bioequivalence guidance (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr) but not the product-specific guidance and an application to TGA is submitted within 2 years of the date of publication of the guidance, sponsors must provide a robust justification for not complying with the product-specific bioequivalence guideline.

*The text under this heading reflects the outcome of a previous consultation ending 9th November 2016

Cardiovascular system

Hypertension

  • EMA/CHMP/29947/2013/Rev. 4
    Guideline on clinical investigation of medicinal products in the treatment of hypertension
    Replaces: EMA/238/1995/Rev. 3 Guideline on clinical investigation of medicinal products in the treatment of hypertension
  • EMA/CHMP/50549/2015
    Reflection paper on assessment of cardiovascular safety profile of medicinal products
    Published for information

Lipid disorders

  • EMA/CHMP/748108/2013, Rev. 3
    Guideline on clinical investigation of medicinal products in the treatment of lipid disorders
    Replaces: EMA/CHMP/748108/2013 Guideline on clinical investigation of medicinal products in the treatment of lipid disorder

Alimentary tract and metabolism

  • EMA/CHMP/311805/2014
    Guideline on clinical evaluation of medicinal products used in weight management
    Replaces: CPMP/EWP/281/96 Rev. 1 Guideline on Clinical Evaluation of Medicinal Products Used in Weight Control

    TGA annotation: 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.

Anti-infectives for systemic use

  • EMEA/CPMP/EWP/633/02 Rev. 3
    Guideline on the clinical development of medicinal products for the treatment of HIV infection
    Replaces: EMEA/CPMP/EWP/633/02 Revision 2 Guideline on the Clinical Development of Medicinal Products for the Treatment of HIV Infection

Biological medicines guidelines

Drug substance

Manufacture, characterisation and control of the drug substance

  • EMA/CHMP/BWP/3354/1999 rev.1
    Guideline on production and quality control of animal immunoglobulins and immunosera for human use
    Replaces: CPMP/BWP/3354/99 Note for Guidance on the Production and Quality Control of Animal Immunoglobulins and Immunosera for Human Use
  • EMA/CHMP/BWP/532517/2008
    Guideline on development, production, characterisation and specification for monoclonal antibodies and related products
    Replaces: EMEA/CHMP/BWP/157653/2007 Guideline on Development, Production, Characterisation and Specifications for Monoclonal Antibodies and Related Products; and: the quality requirements for monoclonal antibodies set out in the guideline 3AQ21a Radiopharmaceuticals Based on Monoclonal Antibodies; and: EMEA/CHMP/CVMP/362268/2009 Concept Paper on the Revision of the Guideline on Radiopharmaceuticals Based on Monoclonal Antibodies
  • EMA/CHMP/BWP/187338/2014
    Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

Multidisciplinary guidelines

Cell therapy and tissue engineering

  • EMA/CHMP/BWP/271475/2006 rev.1
    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