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Australian clinical trial handbook

Guidance on conducting clinical trials in Australia using 'unapproved' therapeutic goods

12 October 2018

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The Australian regulatory environment

Clinical trials are regulated at a number of levels under Commonwealth and state and territory legislation in Australia.

The clinical trial environment in Australia is broad and there are various responsibilities resting with trial sponsors, HRECs, the approving authority (institution), investigators and Commonwealth and state and territory governments.

Australian regulatory requirements are specific to Australia. Trial sponsors who wish to conduct international multicentre trials are responsible for checking the legislative requirements in each country the trial is being conducted in (for example, trial sponsors should contact the U.S. Food and Drug Administration (FDA) for clinical trials conducted in the USA).

Therapeutic goods legislation

Therapeutic goods are regulated in Australia under the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002. TGA is responsible for administering the Australian therapeutic goods legislation.

As regulatory requirements are amended from time to time, it is important to access the current official versions of the legislation. See TGA basics for further information about our role in the regulation of therapeutic goods.

The therapeutic goods legislation relevant to the CTN and CTX schemes are outlined in the table below.

Legislative and regulatory provisions for the CTN and CTX schemes
Therapeutic good Legislation CTN supply provisions CTX supply provisions
Medicines and other therapeutic goods Therapeutic Goods Act 1989
  • section 18(1)
  • section 19(1)(b)
  • section19(1A)-19(4A)
Therapeutic Goods Regulations 1990
  • regulation 12(2)
  • regulation 12AD
  • item 3, Schedule 5A
  • regulations 12AA-12AD
Fee provisions in Therapeutic Goods Regulations 1990
  • items 14 and 14A Schedule 9
  • item 1, Schedule 9
Information request provisions in Therapeutic Goods Act 1989
  • section 31A
  • section 31B
Medical devices Therapeutic Goods Act 1989
  • section 41HA(1)
  • section 41HB(1)
Therapeutic Goods (Medical Devices) Regulations 2002
  • regulation 7.1
  • item 2.3, Schedule 4
  • regulations 7.3-7.5
Fee provisions in Therapeutic Goods (Medical Devices) Regulations 2002
  • item 1.8, Schedule 5
  • item 1.7, Schedule 5
Information request provisions in Therapeutic Goods Act 1989
  • section 41JD
  • section 41JE
Biologicals Therapeutic Goods Act 1989
  • section 32CA(2)
  • sections 32CK(1), 32CL
Therapeutic Goods Regulations 1990
  • regulation 12(2)
  • regulation 12AD
  • item 3, Schedule 5A
  • regulations 12AA- 12AD
Fee provisions in Therapeutic Goods Regulations 1990
  • item 17, Schedule 9A
  • item 16, Schedule 9A
Information request provisions inTherapeutic Goods Act 1989
  • section 32JE
  • section 32JG

This table provides a guide to the Commonwealth therapeutic goods legislation related to the CTN and CTX schemes. Further information on state and territory legislation relevant to other aspects of clinical trial conduct can be found on the Australian Clinical Trials website.

Declaration of Helsinki

The Declaration of Helsinki was used as the basis for developing guidance for good clinical practice in clinical trials. The principles of the Declaration of Helsinki also inform the ethical principles of the National Statement. However, the National Statement is the primary statement on ethical principles related to human research in Australia.

The National Statement on Ethical Conduct in Human Research

Regulation 12AD of the Therapeutic Goods Regulations 1990 and regulation 7.5 of the Therapeutic Goods (Medical Devices) Regulations 2002 provide that the use of therapeutic goods in a clinical trial must be in accordance with the National Statement.

The National Statement is developed jointly by the National Health and Medical Research Council (NHMRC) together with the Australian Research Council (ARC) and Universities Australia. It consists of a series of guidelines made in accordance with the National Health and Medical Research Council Act 1992 that are applicable to research with human participants. The National Statement is the Australian ethical standard against which all research involving humans, including clinical trials, are reviewed. It provides guidance to ensure any research involving humans is ethically sound.

In addition, the NHMRC, together with the ARC and Universities Australia, has also issued the Australian Code for the Responsible Conduct of Research. The purpose of this code is to guide institutions and researchers in responsible research practices. This is to ensure that their work has integrity and aligns with community expectations.

Good Clinical Practice (GCP)

GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. Complying with GCP helps to ensure that the rights, safety and well-being of clinical trial participants are protected and that the trial data generated are credible. We recognise two internationally accepted GCP guidelines:

For the purposes of this handbook the term 'Guideline for Good Clinical Practice' is used to reference the current version of the ICH document adopted by us with annotations.

Guideline for Good Clinical Practice

Regulation 12AD of the Therapeutic Goods Regulations 1990 specifies that the use of medicines and biologicals in a clinical trial must be in accordance with the Guideline for Good Clinical Practice.

The Guideline for Good Clinical Practice was developed by the ICH to provide a unified standard in the United States, the European Union and Japan to assist the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. In order for data generated outside these regions to be accepted for regulatory submission, countries contributing data must ensure their clinical trials are conducted to principles equivalent to this guideline.

To ensure that Australia meets the high standards set out in this guideline, we have not produced a separate guideline for GCP. Instead, we have annotated the Guideline for Good Clinical Practice with TGA comments to ensure it reflects Australia's specific regulatory and governance requirements.

Section 3 of the Guideline for Good Clinical Practice is not applicable to clinical trials in Australia. Instead, the responsibilities, composition, function, operations, procedural and record keeping requirements for HRECs in Australia are set out in the National Statement. If requirements specified in the National Statement appear to differ from those specified in the Guideline for Good Clinical Practice, the TGA recommends compliance with the National Statement.

ISO 14155

ISO 14155 has been developed by the International Organization for Standardization. It addresses GCP for the design, conduct, recording and reporting of clinical investigations carried out in human participants to assess the safety or performance of medical devices for regulatory purposes.

We recognise that ISO 14155 has substantially harmonised with the Guideline for Good Clinical Practice and therefore provides an equivalent standard. It also addresses the specific requirements of investigational medical device trials.

State and territory requirements

Each of the Australian states and territories has separate legislation relevant to the conduct of clinical trials. Investigators, HRECs, approving authorities and trial sponsors should ensure that they comply with the specific requirements for each jurisdiction.

National Mutual Acceptance (NMA) is a national system for mutual acceptance of scientific and ethical review of multi-centre clinical trials undertaken in publicly funded health services. It aims to enable the acceptance of single ethical and scientific review of human research projects in participating jurisdictions. Refer to the relevant state or territory health department for further information.

Research governance is the framework, systems and processes associated with the authorisation, commencement, conduct and monitoring of a clinical trial at a research site. Site authorisation is one part of research governance. Individual jurisdictions have specific requirements as a part of their site-specific assessment and authorisation processes and these include additional compliance with data protection and radiation safety. Further information regarding research governance is available on the Australian Clinical Trials website.

Compliance with the relevant state and territory legislation for the manufacture, possession, supply or use of Scheduled medicines and poisons is also necessary. Scheduling is a national classification system that controls how medicines and poisons are made available to the public. The Schedules are published in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) and are given legal effect through state and territory legislation. The SUSMP is legally referred to as the Poisons Standard. See Scheduling basics for further information regarding the Poisons Standard.

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