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Consultations on adoption of European Union guidelines in Australia

18 December 2019

Your comments on the proposed adoption or non-adoption of these EU guidelines, particularly your advice on whether you support the proposed action, would be appreciated.

Comments may be sent by email or mail and should include your full contact details.

The email address for comments is:

The postal address for comments is:

EU/ICH Guidelines Coordinator
Office of Medicines Authorisation
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

Guidelines proposed for adoption

Closing date: 7 February 2020

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  • Considerations for the inclusion of adolescent patients in adult oncology clinical trials guidance for industry (pdf,87kb)

    Food and Drug Adminsitration effective date: March 2019

  • EMA/CHMP/ICH/167068/2004 (pdf,594kb)*
    ICH Q8 (R2) Pharmaceutical development

    Annotation: This guideline is intended to provide specific guidance on the contents of Section 3.2.P.2 (Pharmaceutical Development) set out in the already adopted EU guideline - 'Common Technical Document for the Registration of Pharmaceuticals for Human Use - Quality (CPMP/ICH/2887/99 - Quality)'

  • EMA/CHMP/760125/2016 (pdf,444kb)
    Clinical investigation of new medicinal products for the treatment of acute coronary syndrome

    Replaces: CPMP/EWP/570/98 - Points to consider on the clinical investigation of new medicinal products for the treatment of acute coronary syndrome (ACS) without persistent ST segment elevation and CPMP/EWP/967/01 - Points to Consider on the Clinical Development of Fibrinolytic Medicinal Products in the Treatment of Patients with St Segment Elevation Acute Myocardial Infarction (STEMI)

  • CPMP/EWP/556/95 Rev. 2 (pdf,203kb)
    Clinical investigation of medicinal products for treatment of rheumatoid arthritis
  • EMA/CHMP/774470/2018 (pdf,324kb)
    Clinical investigation of medicinal products for the treatment of gout

    Effective: 1 June 2020

  • EMA/CHMP/458101/2016 (pdf,214kb)
    Reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation
  • EMA/HMPC/104613/2005 Rev. 1 (pdf,171kb)
    Assessment of clinical safety and efficacy in the preparation of EU herbal monographs for well-established and traditional herbal medicinal products

    Annotation: The TGA does not consider this guideline to be applicable to complementary medicine applications seeking indications based on established tradition of use. In Australia, an established tradition of use is considered to be three generations of human use, equating to approximately 75 years.

  • EMEA/HMPC/166326/05 (pdf,155kb)
    Clinical assessment of fixed combinations of herbal substances/herbal preparations

    Annotation: The TGA does not consider this guideline to be applicable to complementary medicine applications seeking indications based on established tradition of use. In Australia, an established tradition of use is considered to be three generations of human use, equating to approximately 75 years.

  • EMA/CHMP/236981/2011, Corr. 1 (pdf,207kb)
    Clinical investigation of medicinal products for the treatment of Duchenne and Becker muscular dystrophy
  • CPMP/1100/02 (pdf,244kb)
    Development of vaccinia virus-based vaccines against smallpox
  • EMA/56793/2014 Rev. 1 (pdf,315kb)
    Influenza vaccines - submission and procedural requirements
  • EMA/CHMP/BWP/133540/2017 (pdf,185kb)
    Quality aspects included in the product information for vaccines for human use
  • EMA/CHMP/VWP/141697/2009 (pdf,131kb)
    Quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines
  • EMEA/CPMP/4548/03/Final (pdf,274kb)
    Scientific data requirements for a vaccine antigen master file
  • EMA/CHMP/257022/2017 (pdf,227kb)
    Treatment and prophylaxis of respiratory syncytial virus (RSV) disease
  • EMA/CPMP/ICH/2887/1999 (pdf,603kb)* ICH M4E (R2) Common technical document for the registration of pharmaceuticals for human use - efficacy

    Replaces: CPMP/ICH/2887/99 Rev 1 - Efficacy CTD for the registration of pharmaceuticals for human use - clinical overview and clinical summary of Module 2 and Module 5: clinical study reports

  • EMA/CHMP/ICH/83812/2013 (pdf,1.34mb)* ICH guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk

    Replaces: ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk

  • EMA/CHMP/ICH/453684/2016 (pdf,398kb)
    ICH S9 Q&As Nonclinical Evaluation for Anticancer Pharmaceuticals — Questions and Answers
  • EMA/CHMP/500825/2016 (pdf,160kb)
    Guideline on the clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency

    Annotation: Indigenous Australians experience a high rate of renal disease. Ideally, these should be included in clinical trials or a clinical trial in this group should be considered in the post market setting.

    Many different terms are used to describe renal impairment, renal injury, renal failure. These terms should be clearly defined.

    Where biomarkers are used - e.g. creatinine, urine albumin excretion, cystatin C - the value of these measures in the prediction of development of renal impairment should be included.

    Outcomes should include need for renal replacement therapy or transplant.

    Different centres may have different protocols for the management of CRF, thus clinical studies should include a protocol shared between sites, or results adjusted for potential differences in study centres.

Guidelines proposed for non-adoption

  • CPMP/ICH/541/00 (pdf,148kb)
    ICH E12 Principles for clinical evaluation of new antihypertensive drugs

    The topics covered by this document are covered in greater detail in 'EMA/CHMP/29947/2013/Rev. 4 Guideline on clinical investigation of medicinal products in the treatment of hypertension' which has been adopted by the TGA.