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Half-yearly performance reports - July to December 2014

31 March 2015

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What the TGA regulates

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.

As part of the Department of Health, the TGA safeguards and enhances the health of the Australian community through effective and timely regulation of therapeutic goods.

The TGA is responsible for ensuring that therapeutic goods available for supply in or exported from 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 TGA regulates the supply, manufacturing and advertising of these products:

  • 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.

How the TGA regulates

The Australian community expects therapeutic goods in the marketplace to be safe, of high quality and of a standard at least equal to that of comparable countries.

The TGA regulates therapeutic goods through:

  • premarket assessment and market authorisation
  • postmarket monitoring and enforcement of standards; and
  • ensuring manufacturing facilities, whether in Australia or overseas, comply with internationally recognised standards.

Therapeutic goods are divided broadly into three classes: biologicals, medicines and medical devices. Unless exempt, biologicals and medical devices must be 'included' and medicines must be entered as either 'registered' or 'listed' medicines on the ARTG before they may be supplied in or exported from Australia.

If a problem is discovered with a medicine, device or manufacturer, the TGA is able to take a variety of regulatory actions. Possible actions vary and may include continued monitoring through to withdrawing the product from the market or in some circumstances referral to the Commonwealth Director of Public Prosecutions for possible prosecution in relation to criminal offences.

Regulating medicines

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 required to meet standards 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 that allows safety problems to be identified and actions taken to minimise any further potential for harm to patients.

Regulating medical devices

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 incident reporting programme that allows for early identification of potential safety issues.

Other therapeutic goods regulated by the TGA

The TGA also applies a risk management approach to the regulation of:

  • in vitro diagnostic medical devices (IVDs)
  • blood
  • blood components
  • plasma derivatives
  • tissue and cellular products
  • tissue and cell based derivatives
  • sterilants and disinfectants.

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