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

15 November 2016

Following consultation within the TGA and with relevant external stakeholders including Industry and Consumer groups, ending 9 November 2016, the following EU/ICH guidelines have been adopted by the TGA, effective 10 November 2016 unless indicated otherwise:

Clinical efficacy and safety guidelines

Clinical pharmacology and pharmacokinetics

  • EMA/83874/2014
    Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function
    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.

Blood products (including biotech alternatives)

  • EMA/CHMP/BPWP/144533/2009 Rev 1.
    Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products (Rev. 1)
    Replaces: EMA/CHMP/BPWP/144533/2009. Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products

Cardiovascular system

Venous thromboembolism

  • EMA/CHMP/41230/2015
    Guideline on clinical investigation of medicinal products for the treatment of venous thromboembolic disease
    Replaces: CPMP/EWP/563/98. Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Venous Thromboembolic Disease

Antineoplastic and immunomodulating agents

  • EMA/CHMP/703715/2012 Rev.2
    Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man Condition specific guidance
    Replaces: EMA/CHMP/703715/2012. Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man Condition Specific Guidance.

    TGA annotation:Part 6 of this guideline "The role of the pathological Complete Response as an endpoint in neoadjuvant breast cancer studies" will be adopted following implementation of a provisional registration process by the TGA.

Rheumatology / musculoskeletal system

  • EMA/CHMP/239770/2014 Rev 2
    Guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis
    Replaces: CPMP/EWP/422/04. Guideline on Clinical Investigation of Medicinal Products for the Treatment of Juvenile Idiopathic Arthritis; and EMA/CHMP/520782/2012. Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis

Nervous system

  • EMA/CHMP/236981/2011
    Guideline on the clinical investigation of medicinal products for the treatment of Duchenne and Becker muscular dystrophy
  • EMA/531686/2015
    Guideline on the clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis (ALS)
    Replaces: CPMP/EWP/565/98. Points to Consider on Clinical Investigation of Medicinal Products for the Treatment of Amyotrophic Lateral Sclerosis (ALS); and EMA/CHMP/59352/2012. Concept paper on the need for revision of the points to consider on clinical investigation of medicinal products for the treatment of Amyotrophic Lateral Sclerosis

Respiratory system

  • CHMP/EWP/2922/01 Rev.1
    Guideline on the clinical investigation of medicinal products for the treatment of asthma
    Replaces: CPMP/EWP/2922/01. Note for Guidance on the Clinical Investigation of Medicinal Products in the Treatment of Asthma

Multidisciplinary guidelines

Pharmacogenomics

  • EMA/CHMP/281371/2013
    Guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products.

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