Therapeutic Goods Administration (TGA) : An Australian Regulatory Authority

The Therapeutic Goods Administration (TGA) is Australia’s regulatory authority for therapeutic goods. It carry out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances. The Therapeutic Goods Administration (TGA) is a division of the Australian Department of Health and Ageing. Its principal role is as the national regulator of therapeutic goods – a collective term covering medicines, medical devices and some related products. the TGA administers the Therapeutic Goods Act 1989, the objects of which include ‘a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia, whether produced in Australia or elsewhere, or exported from Australia’. These activities are fully funded by fees charged for assessments, annual registrations and inspections.

The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products. Almost any product for which therapeutic claims are made must be entered in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.

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The TGA is responsible for ensuring that therapeutic goods available for supply in Australia are safe and fit for their intended purpose. These include goods Australians rely on every day, such as vitamin tablets and sunscreens, through to goods used to treat serious conditions, such as prescription medicines, vaccines, blood products and surgical implants. The lawful supply of any therapeutic good in Australia requires that the product is included on the Australian Register of Therapeutic Goods (ARTG). There are two types of entry on the ARTG. Some products are ‘registered’ and have an AUST R number on their label. Other products are ‘listed’ and have an AUST L number. the TGA decides if products are suitable for listing or require registration. Manufacturers are not permitted to suggest or imply in their advertisements that inclusion in the ARTG is a recommendation or endorsement by the TGA.

The TGA regulates the supply of:

  • medicines prescribed by a doctor or dentist
  • medicines available from behind the pharmacy counter
  • medicines available in the general pharmacy
  • medicines available from supermarkets
  • complementary medicines, these include vitamins, herbal and traditional medicines
  • medical devices, from simple devices like bandages to complex technologies like heart pacemakers
  • products used to test for various diseases or conditions (in vitro diagnostic devices), such as blood tests; and
  • vaccines, blood products, and other biologics.

The regulation of medicines includes the following features:

  • classifying the medicine based on different levels of risk to the person taking them
  • implementing appropriate regulatory controls for the manufacturing processes of medicines
  • Medicines assessed as having a higher level of risk (prescription medicines, some non-prescription medicines) are evaluated for quality, safety and efficacy
  • Ingredients in medicines with a lower risk (medicines purchased over the counter, such as complementary medicines) are assessed for quality and safety
  • Medicines determined to be available for lawful supply by the Therapeutic Goods Administration can be identified by either an AUST R number or an AUST L number on the outer packaging. Please note, there are a small number of medicines that are exempt and do not require this information on the label
  • Once available for supply, medicines are subject to monitoring by the TGA. This monitoring includes a comprehensive adverse event reporting programme.
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The regulation of medical devices includes:

  • classifying the medical device based on different levels of risk to the user
  • assessing compliance with a set of internationally agreed essential principles for their quality, safety and performance
  • implementing appropriate regulatory controls for the manufacturing processes of medical devices
  • including the medical device in the Australian Register of Therapeutic Goods
  • Once available for supply, medical devices are subject to monitoring by the TGA. This monitoring includes a comprehensive adverse event reporting programme.

The Therapeutic Goods Administration is a Commonwealth Government agency that regulates medical devices and drugs. Prescription medicines and over-the-counter medicines which meet Australian standards of quality, safety and efficacy are included on the Australian Register of Therapeutic Goods. Medicines may be registered or listed. Registered products are thoroughly evaluated and are labelled with an AUST R number. Listed products, such as complementary medicines, do not have to undergo the same assessments and are labelled with an AUST L number. They are not routinely evaluated before marketing, but are subject to a random audit after listing.

Nowadays an application for registration of a new active substance must be supported by extensive information about the synthesis of the substance, the method of manufacture of the dose forms, studies of its pharmacology and toxicology in animals and clinical trials in humans demonstrating the efficacy and safety of the product in its proposed use. In addition, certification that manufacture has complied with Good Manufacturing Practice is obligatory.Registration in Australia does not expire. A product remains registered unless there are grounds for cancellation or the sponsor ceases marketing. A small number of active substances, such as aspirin, were supplied in Australia long before any evaluation process was in place. Their registration is not reviewed unless a safety issue arises or a change in use is proposed.

Many of the prescription medicines used in Australia are versions of the innovator product, usually produced by other manufacturers. These generic products are subject to the same regulation of manufacture and quality standards. However, only evidence that the formulation is bioequivalent to the innovator product is required, rather than a full demonstration of efficacy and safety. Bioequivalence studies usually involve a comparative study of the product in human volunteers, but benchtop testing of dissolution may suffice for some products. Similar testing in human volunteers is required to support the claims of modified-release formulations.

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