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Guideline
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ICH E6(R3) Guideline for Good Clinical Practice: Principles and Annex 1 - Effective: 13 January 2026
Replaces: Integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)
A transition period from 13 January 2026 to 13 January 2027 is included to allow stakeholders time to meet the updated requirements. For more information see Transition Period below.
Introductory comments of the TGA
The ICH Guideline for Good Clinical Practice (ICH E6(R3)) is an internationally accepted standard for designing, conducting, recording and reporting of clinical trials. The ICH Guideline for Good Clinical Practice is incorporated into Australian law (without modification) by reference in the Therapeutic Goods Regulations 1990. Compliance with the ICH Guideline for Good Clinical Practice is a condition of use of ‘unapproved ’ medicines and biologicals solely for experimental purposes in humans under the Clinical Trial Notification (CTN) and Clinical Trial Approval (CTA) schemes.
The TGA has prepared the following comments to assist stakeholders in complying with the ICH Guideline for Good Clinical Practice in accordance with local regulatory requirements.
Australian regulatory requirements
In Australia, the National Health and Medical Research Council Act 1992 establishes the National Health and Medical Research Council (NHMRC) as a statutory body to pursue and foster issues relating to public health. The NHMRC is required to issue guidelines for the conduct of medical research and ethical matters related to health.
The National Statement on Ethical Conduct in Human Research (the National Statement) has been produced by the NHMRC as the Australian ethical standard against which all research involving humans, including clinical trials, are reviewed.
The National Statement is incorporated into Australian law (without modification) by reference in the Therapeutic Goods Regulations 1990. If the National Statement and the ICH Guideline for Good Clinical Practice have different requirements in relation to a matter, the more rigorous requirement must be followed.
| Relevant section(s) of ICH E6(R3) | TGA comment |
| The TGA has adopted ICH guideline E8(R1) on general considerations for clinical studies along with other scientific guidelines referenced in the ICH Guideline for Good Clinical Practice. Compliance with E8(R1) and other scientific guidelines adopted by the TGA is not a condition of the CTA or CTN scheme. These guidelines are adopted to assist stakeholders comply with the ICH Guideline for Good Clinical Practice. All adopted guidelines can be found on the TGA’s International Scientific Guidelines Adopted in Australia webpage.
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| General ethical guidance on obtaining valid consent to participate in research can be found in Chapter 2.2 (General requirements for consent) of the National Statement. Refer to the National Statement for guidance on designing research that considers participants' capacity to receive information and information on obtaining valid consent in special conditions and circumstances at Chapter 3.1 (The elements of research) and Chapter 3.3 (Genomic research) and, for specific research participant groups, Chapter 4.1 (Ethical issues in recruitment and involvement of research participants who may experience increased risk). Refer to Chapter 4.3 (Children and Young People) and Chapter 4.5 (People experiencing physical or mental ill-health or disability) for guidance on obtaining valid consent where individuals lack the capacity to provide their consent to participate in research. The National Statement supports the use of a waiver of the requirement for consent (2.3.9-2.3.10) and, in narrow circumstances, HREC approval to proceed without the requirement for consent (4.5.21-4.5.23). Chapter 4.5 clarifies that consent can only be obtained prior to recruitment and prohibits the use of delayed or deferred consent or obtaining consent retrospectively (4.5.7 and language preceding 4.5.17) in the design or conduct of human research in Australia. If a participant regains capacity to provide consent, researchers should seek to obtain agreement from the participant to continue participation in the research. Where approval to proceed without consent has been granted by the HREC, any subsequent steps to inform participants or their representatives of participation should not be described as seeking agreement or obtaining consent. Further information on the use of alternative pathways for recruiting individuals to participate in research is provided in Chapter 2.3 of the National Statement. Further information about requirements for obtaining valid consent in special cases can be found in the National Statement. |
| The Therapeutic Goods Act 1989 defines an ethics committee as a committee constituted and operating in accordance with guidelines issued by the NHMRC as in force from time to time; and which has notified its existence to the Australian Health Ethics Committee established under the National Health and Medical Research Council Act 1992. The Institutional Review Board (IRB)/Independent Ethics Committee (IEC), known in Australia as a Human Research Ethics Committee (HREC), must notify their existence to the NHMRC directly. The responsibilities, composition, function, operations, procedural and record keeping requirements for HRECs in Australia are set out in the National Statement. |
| The 'applicable GMP' in Australia refers to the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (in particular Annex 13) and the Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products. |
| All clinical trials conducted in Australia must have a trial sponsor that is an Australian entity (an overseas company cannot be the sponsor of a trial in Australia). The Australian trial sponsor retains overall responsibility for the conduct of the trial in Australia.
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| The TGA has adopted the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting in principle, particularly its reporting timeframes. Trial sponsors should refer to the current guidance published by the NHMRC: Safety monitoring and reporting in clinical trials involving therapeutic goods. |
| The period for which records should be retained is determined by applicable state, territory and/or national law, together with prevailing standards for the specific type of research. As a general rule, the Australian Code for the Responsible Conduct of Research recommends that clinical trial records should be retained for a minimum of 15 years after trial completion noting that longer or permanent retention periods may apply for certain trial types. With respect to record retention, Australian trial sponsors should consider the issue of product liability and the potential need for sponsors of products to produce records at any time during, and possibly beyond, the life of a product in the event of a claim against the sponsor as a result of an adverse outcome associated with the use of the product.
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| Trial Registration The National Statement requires researchers to ensure that their trials are registered in a publicly accessible database before recruitment of the first participant. The National Statement requires trial registration on a registry that complies with the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) e.g. Australian New Zealand Clinical Trials Registry (ANZCTR).
Public Posting of Trial Results Further information about requirements for the timely dissemination of project outputs and outcomes can be found in the National Statement.
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Transition period
ICH E6(R3) Guideline for Good Clinical Practice: Principles and Annex 1 come into effect on 13 January 2026, marking the start of a 12-month transition period. The transition period will end on 13 January 2027. During this transition period, clinical trials of medicines and biologicals regulated under the CTN and CTA schemes must comply with either ICH E6(R2) or ICH E6(R3). The transition period allows sponsors, trial sites and other stakeholders time to update processes, documentation, and training to meet the updated requirements.
Clinical trial sites should:
- Review ICH E6(R3) with TGA comments to understand what’s changed. This will help you identify differences between your current practices and the requirements of ICH E6(R3).
- Develop a plan - if gaps are identified, develop a plan to meet the updated requirements and document how the review and updates were carried out. Please note that amendments to study documentation approved by the Human Research Ethics Committee (HREC) should be submitted to the HREC for review and, approving authority (or research governance office) prior to implementation.
Undertake training - The Principal Investigators (PIs) should be trained on ICH E6(R3), as they are responsible for trial conduct at the site. The PI should ensure that team members receive training on the requirements of ICH E6(R3) suited to their delegated tasks. Keep records of all relevant training completed and which ICH guideline version was used.
Annex 2
Annex 2 forms part of the ICH E6(R3) Guideline for Good Clinical Practice. It provides additional guidance for modern clinical trial designs and data sources.
Once the ICH has finalised Annex 2, the TGA will undertake consultation through its standard process, which includes internal review and public consultation prior to adoption.
Consultation
| Consultation | Status |
| Proposed TGA Annotations to ICH E6(R3) Guideline for Good Clinical Practice (GCP): Principles and Annex I and 12-month Transition Period | Consultation closed 10 October 2025 Outcomes published 16 December 2025 |