The regulation of nutrigenetic tests in Australia

Guidance document

March 2007

Disclaimer

This document is intended as a guide only. It should not be relied upon to address every aspect of relevant legislation. Please refer to the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Regulations 1990 for current legislative requirements.

The Therapeutic Goods Administration (TGA) intends to implement a new regulatory framework for in vitro diagnostic devices (IVDs). Under the new framework, IVDs will be regulated as medical devices and the provisions of the Therapeutic Goods (Medical Devices) Regulations 2002 will be widened to include IVDs. Specific legislation incorporating the regulatory requirements for IVDs is yet to be published.

It is possible that the new regulations will be implemented at the commencement of the Trans-Tasman joint regulatory agency, Australia New Zealand Therapeutic Products Authority (ANZTPA). In this event, the legislation governing IVDs will be published in the Australia New Zealand Therapeutic Products Regulatory Scheme (Medical Devices) Rule. Consequent to this, all guidance will be amended to reflect the regulatory requirements for both countries.

It should be noted that until the time of implementation of the new IVD framework the provisions of Chapter 3 of the Act and the Therapeutic Goods Regulations 1990 still apply to other therapeutic goods (which include IVDs). The TGA is not liable for any loss whatsoever whether due to negligence or otherwise arising from the use of or reliance on this document.

Further information

For general enquiries relating to in vitro diagnostic devices (IVDs) contact the TGA Office of Devices, Blood and Tissues, Application Entry and Coordination Section at:

© Commonwealth of Australia 2007

Background

Nutritional genomics is a science studying the relationship between the human genome, nutrition and health. It can be divided into two subcategories:

1. Nutrigenomics: studies the effect of nutrients on the genome at the molecular, cellular and systemic levels.
2. Nutrigenetics: studies the effect of genetic variations on the interaction between diet and health, with implications to susceptible subgroups.¹

The field of nutrigenetics provides the basis for personalised dietary recommendations based on an individual's genetic makeup, in order to prevent common multifactorial disorders decades before their clinical manifestation. The potential to change the future of dietary guidelines and personal diet recommendations is fuelled by an increasing number of sophisticated molecular techniques available for interrogating the human genome.

Practical applications arising from the science of nutritional genomics must be supported by stringent validation of any claims. As a consequence, a personalised approach to medicine using tools such as nutrigenetics is beginning to be explored, but requires much more clinical and translational research before it is broadly accepted.

1 Ordovas JM, Mooser V, Nutrigenomics and nutrigenetics, Curr Opin Lipidol, 2004 Apr;15(2):101-8.

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The regulation of nutrigenetic tests in Australia

Dependant upon the claims made by the manufacturer of each test, nutrigenetic tests are considered to be therapeutic goods and therefore must comply with the requirements of the Act.

In this document, the term "nutrigenetic tests" is used and is intended to encompass all nutritional genomic assays that fall under the definition of a therapeutic good.

The Act broadly defines a 'therapeutic good' as a good which is represented in any way to be, or is likely to be taken to be, for therapeutic use (unless specifically excluded or included under Section 7 of the Act).

Therapeutic use means use in or in connection with:

• preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury;
• influencing, inhibiting or modifying a physiological process;
• testing the susceptibility of persons to a disease or ailment;
• influencing, controlling or preventing conception;
• testing for pregnancy; or
• replacement or modification of parts of the anatomy.

Any tests that are intended to be used, or that are marketed for their potential to influence a physiological process will be required to fulfill both current and future regulatory requirements.

Current regulation of nutrigenetic tests

Under the current regulatory framework, nutrigenetic tests are regulated as therapeutic devices and to be legally supplied in Australia, must comply with the regulations for these goods as described in the Therapeutic Goods Regulations 1990. Further details are described in The Australian Medical Device Requirements, version 4 (DR4) <http://www.tga.gov.au/docs/html/dr4.htm>.

The requirements for entry onto the Australian Register of Therapeutic Goods (ARTG) will depend on whether the Regulations define the test as listable or exempt. Nutrigenetic tests that contain material of human origin or that are for self testing (ie. for home use, sold through pharmacies etc) are listable and must be entered on the ARTG. Evidence of Good Manufacturing Practice (GMP), product information, instructions for use and any promotional material for listable IVDs must be provided to the TGA prior to entry on the ARTG. It is likely that most nutrigenetic tests will fall into the exempt category.

Exempt goods are free from the requirements for registration or listing as specified in Schedule 5 and 5A of the Therapeutic Goods Regulations 1990, and do not require entry on the ARTG. Exempt goods are still required to comply with labelling requirements, relevant standards and the advertising provisions of the Act. In addition, sponsors are required to report any problems such as serious adverse events. Reporting is also encouraged from users of these assays.

Future regulation of nutrigenetic tests

The TGA proposes to introduce new legislation that will affect all IVDs. Nutrigenetic tests will be regulated under the new IVD framework.

The definition of an IVD to be adopted in the new legislation is:

Some key elements of the new IVD framework are:

• All IVDs must be manufactured in a manner to ensure safety, quality and performance is apparent at all times when used according to the manufacturer's intended purpose.
• Regulatory oversight will be commensurate with the level of risk the use of the IVD poses to the health of an individual or the public. This is achieved by the manufacturer classifying each IVD according to a set of risk based rules into 4 classes (Classes 1-4) with IVDs classified as Class 4 having the highest regulatory oversight.
• The classification rules are predicated as follows:
  • High public health risk, high personal risk = Class 4 IVDs
  • Moderate public health risk, high personal risk = Class 3 IVDs
  • Low public health risk, moderate personal risk = Class 2 IVDs
  • Low public health risk, low personal risk = Class 1 IVDs
• The new framework will include the regulation of IVDs produced commercially and produced "in-house". The definition of an in-house IVD that will be incorporated into legislation is:

  "An IVD that is developed de novo, or developed or modified from a published source, or developed or modified from any other source, or its intended purpose, within the confines or scope of a laboratory or laboratory network, and is not supplied for use outside the laboratory or laboratory network."

  Many nutrigenetic tests are manufactured "in-house".

• In response to concerns of Australian governments, the TGA is intending to implement regulatory mechanisms that will prohibit access to home use (self testing) tests for serious disease markers. These will include tests for notifiable infectious diseases, cancer markers, cardiac markers and genetic tests.
• Key aspects of the forthcoming IVD regulations in relation to nutrigenetic tests are:
  • Most nutrigenetic tests are likely to be classified as Class 2 or Class 3 IVDs. They will be required to be included on the ARTG, and the manufacturer must hold evidence of compliance with the Essential Principles, as described in forthcoming legislation.
  • Access to nutrigenetic assays that are for self testing or home use for the management of serious diseases will not be approved.
  • Commercial manufacturers must have in place a Quality Management System for manufacture. The accepted QMS standard is ISO 13485: 2003 Medical devices - Quality management systems - Requirements for regulatory purposes. For more details of the requirements for manufacturer's evidence under the new IVD framework refer to the Forthcoming (new) regulatory framework for IVDs. <http://www.tga.gov.au/ivd/forthcoming.htm>
  • Many nutrigenetic tests are developed by laboratories as "in-house" tests. In these cases, it is proposed that compliance with requirements may be demonstrated by National Association of Testing Authorities, Australia (NATA) medical accreditation that includes all nutrigenetic assays in the scope of the accreditation.
  • All manufacturers of nutrigenetic tests must hold sufficient data to support all analytical and clinical claims made regarding the product. The requirements for clinical evidence will be adopted from the recommendations of the Global Harmonisation Task Force which are currently in development.
• The above requirements will provide assurance that the IVDs are made using quality systems for ongoing quality, safety and performance. The quality system approach relies on control of processes using quality assurance controls both during production and during use.
• Commercial manufacturers must have systems in place to ensure ongoing quality in the post market phase.
  • Manufacturers and sponsors will be obliged to report any serious adverse events to the TGA for further investigation.
  • Manufacturers, sponsors and users of genetic tests are encouraged to report to the TGA any occasions where the quality, safety or performance of a genetic test is in doubt, when used according to the intended purpose.

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