Adoption of international scientific guidelines in Australia

Earlier this year we conducted a public consultation on whether we should adopt certain international scientific guidelines. Following an extensive internal and external consultation process, we have adopted the following 13 international scientific guidelines:

1. ICH M9 guideline on biopharmaceutics classification system-based biowaivers (ICH M9; EMA/CHMP/ICH/493213/2018)
2. ICH Harmonised guideline - Nonclinical safety testing in support of development of paediatric pharmaceuticals (ICH S11)
3. ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population – Addendum (ICH E11(R1); EMA/CPMP/ICH/2711/1999)
4. ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals (ICH S1B(R1); EMA/774371/2022)
5. Cancer clinical trial eligibility criteria: patients with organ dysfunction or prior or concurrent malignancies (FDA-2019-D-0359)
6. ICH Electronic Common Technical Document (eCTD) v4.0 - Implementation Guide v1.5 (ICH M8 Expert Working Group)
7. Guideline on the evaluation of anticancer medicinal products in man (EMA/CHMP/205/95 Rev. 5)
8. ICH guideline E8 (R1) on general considerations for clinical studies (ICH E8 (R1); EMA/CHMP/ICH/544570/1998 Corr*)
9. ICH guideline Q3C (R8) on impurities: guideline for residual solvents (ICH Q3C (R8); EMA/CHMP/ICH/82260/2006 Corr.*)
10. ICH M7(R2) Guideline on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk (ICH M7 (R2); EMA/CHMP/ICH/83812/2013)
11. ICH M7(R2) Addendum on application of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakes (ICH M7 (R2); EMA/CHMP/ICH/5072766/2021)
12. ICH guideline M10 on bioanalytical method validation and study sample analysis (ICH M10; EMA/CHMP/ICH/172948/2019)
13. ICH guideline Q3D (R2) on elemental impurities (ICH Q3D (R2); EMA/CHMP/ICH/353369/2013)

While international scientific guidelines that are adopted in Australia are not mandated by legislation, they are intended to provide advice to applicants and/or sponsors to assist them in meeting legislative requirements. This includes the most appropriate way to interpret and fulfil the obligations to demonstrate safety, quality and efficacy as set out in the Therapeutic Goods Act 1989. This advice represents a harmonised approach and is based on the most up-to-date scientific knowledge.

Enquiries

For enquiries relating to the consultation please email isguidelines@health.gov.au.