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International scientific guidelines adopted in Australia

5 August 2020

The TGA closely aligns its regulatory approaches to therapeutic products with those of comparable international regulatory counterparts wherever possible.

Technical data requirements for applications to register or vary the registration of medicines in Australia are closely aligned with requirements set out in relevant:

  • European Union (EU) Guidelines
  • Guidelines issued by the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use
  • Food and Drug Administration (USA)

International Guidelines are not limited to prescription medicines, but may also apply to OTC, complementary and some listed medicines. It is important that you review the relevant guidelines that are adopted in Australia prior to manufacturing and supplying a medicine.

While guidelines that are adopted in Australia are generally not mandated by legislation, they provide guidance to sponsors to assist them to meet the legislative requirements and any deviation from a Guideline relevant to an application to register or vary the registration of a medicine must be justified.

Prior to adopting any Guideline, the TGA undertakes an extensive process of internal and external consultations to ensure the Guideline is consistent with prevailing requirements in Australia. TGA publishes a searchable list of International Guidelines adopted in Australia. Please check for current consultations on proposed guidelines for adoption in Australia.

Please note: Where EU Guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.

International scientific guidelines adopted in Australia

Displaying 11 - 20 of 373

TGA adopted date: 28 Feb 2020

Overseas effective date: 1 Jun 2006

Clinical assessment of fixed combinations of herbal substances/herbal preparations

Categories: Quality

Applicants must be able to demonstrate an established tradition of use for traditional use indications in Australia. Please refer to the Australian Regulatory Guidelines for Complementary Medicines, which identify traditional use as generally equating to three generations of human use.

TGA adopted date: 28 Feb 2020

Overseas effective date: 1 Mar 2007

Assessment of clinical safety and efficacy in the preparation of EU herbal monographs for well-established and traditional herbal medicinal products

Categories: Quality

Applicants must be able to demonstrate an established tradition of use for traditional use indications in Australia. Please refer to the Australian Regulatory Guidelines for Complementary Medicines, which identify traditional use as generally equating to three generations of human use.

TGA adopted date: 28 Feb 2020

Overseas effective date: 1 Jul 2019

Reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation

Categories: Clinical efficacy and safety | Clinical pharmacology and pharmacokinetics

TGA adopted date: 28 Feb 2020

Overseas effective date: 1 Jun 2020

Clinical investigation of medicinal products for the treatment of gout

Categories: Clinical efficacy and safety | Rheumatology / musculoskeletal system

TGA adopted date: 28 Feb 2020

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)

Categories: Clinical efficacy and safety | Cardiovascular system | Coronary artery disease (CAD)

TGA adopted date: 28 Feb 2020

Overseas effective date: 15 Jun 2006

ICH guideline Q8 (R2) on pharmaceutical development

Categories: Quality | Pharmaceutical development (quality)

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)'

TGA adopted date: 28 Feb 2020

Overseas effective date: 1 Mar 2019

Considerations for the inclusion of adolescent patients in adult oncology clinical trials - Guidance for Industry

Categories: Clinical efficacy and safety | Antineoplastic and immunomodulating agents

TGA adopted date: 28 Feb 2020

Overseas effective date: 31 Jan 2017

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

Categories: Multidisciplinary

TGA adopted date: 28 Feb 2020

Overseas effective date: 31 Jan 2017

ICH M4Q Common technical document for the registration of pharmaceuticals for human use - quality

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

Categories: Multidisciplinary

TGA adopted date: 28 Feb 2020

Overseas effective date: 21 Jul 2016

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

Categories: Multidisciplinary | Miscellaneous

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