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

12 February 2016

Following consultation within the TGA and with relevant external stakeholders including Industry and Consumer groups, ending 1 February, the following EU/ICH guidelines have been adopted by the TGA, effective 2 February 2016 unless indicated otherwise:

Clinical efficacy and safety guidelines

Alimentary tract and metabolism

  • EMA/CHMP/336243/2013 (pdf,219kb)
    Guideline on the evaluation of medicinal products for the treatment of chronic constipation (including opioid induced constipation) and for bowel cleansing
    In place of: EMA/CHMP/462198/2012 Concept paper on the need of a guideline for clinical investigation of medicinal products for the treatment of chronic constipation

Blood products (including biotech alternatives)

  • CHMP/BPWP/585257/2009 (pdf,147kb)
    Guideline on the clinical investigation of hepatitis B immunoglobulins
  • CHMP/BPWP/410415/2011 Rev 1 (pdf,246kb)
    Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg)
    To replace: EMEA/CPMP/BPWG/283/00 Note for Guidance on the Clinical Investigation of Human Normal Immunoglobulin for Subcutaneous and Intramuscular Use

Cardiovascular system

Heart failure
  • CPMP/EWP/2986/03 Rev. 1 (pdf,194kb)
    Guideline on clinical investigation of medicinal products for the treatment of acute heart failure
    To replace: CPMP/EWP/2986/03 Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Cardiac Failure. Addendum on Acute Cardiac Failure (CPMP/EWP/235/95 Rev 1); and EMA/CHMP/EWP/215701/2010 Concept paper on the need for revision of the addendum on acute cardiac failure (CPMP/EWP/2986/03)

Biological medicines guidelines

Batch release guidelines

Addition of:

  • Live Attenuated Influenza Vaccine

Nonclinical guidelines

Toxicology

Local tolerance
  • CHMP/SWP/2145/2000 Rev. 1 (pdf,128kb)
    Guideline on non-clinical local tolerance testing of medicinal products
    To replace: CPMP/SWP/2145/00 Note for Guidance on Non-Clinical Local Tolerance Testing of Medicinal Products
    To become effective 1 May 2016