Therapeutic Goods Association (TGA)

What does the Therapeutic Goods Association do?

The Therapeutic Goods Association (TGA) is a national body responsible for regulating therapeutic goods in Australia. The TGA is part of the Department of Health and Ageing and is headquartered in Canberra.

The TGA's primary role is to protect public health by ensuring that therapeutic goods (including medicines, medical devices and blood products) available in Australia are of an acceptable standard. The TGA also plays a role in promoting the safe and effective use of therapeutic goods.

The TGA assesses the quality, safety and efficacy of therapeutic goods before they are allowed to be supplied in Australia. The TGA also monitors the safety of therapeutic goods once they are on the market.

The TGA is responsible for the regulation of:

medicines

medical devices

blood and blood products

human tissue

The TGA is not responsible for the regulation of:

cosmetics

food

complementary medicines

veterinary medicines

The TGA works with a number of other organisations to regulate therapeutic goods, including:

the Australian Competition and Consumer Commission (ACCC)

the Australian Customs and Border Protection Service (ACBPS)

the Department of Agriculture

state and territory health departments

The TGA also works with international regulatory bodies to ensure that therapeutic goods supplied in Australia meet international standards.

The TGA is a member of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH is a forum for the development of international standards for the registration of pharmaceuticals.

The TGA is also a member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S). PIC/S is an international organisation that promotes harmonisation of Good Manufacturing Practice (GMP) inspections of pharmaceutical manufacturers.

The TGA is accredited by the PIC/S to carry out GMP inspections of pharmaceutical manufacturers in Australia.

The TGA has a number of committees and working groups that provide advice on various aspects of the regulation of therapeutic goods.

The TGA also relies on input from consumers, health professionals and industry to help it make informed decisions about the regulation of therapeutic goods.

What is the Therapeutic Goods Association?

The Therapeutic Goods Association (TGA) is a national body responsible for the regulation of therapeutic goods in Australia. The TGA is part of the Australian Government Department of Health and is headquartered in Canberra.

The TGA's primary role is to protect public health by ensuring that therapeutic goods (including medicines, medical devices and blood products) available in Australia are of an acceptable standard. The TGA also plays a role in promoting the safe and effective use of therapeutic goods.

The TGA is responsible for the regulation of a wide range of therapeutic goods, including:

medicines

medical devices

blood and blood products

tissues and cells

gene technology products

cosmetic surgery

complementary medicines.

The TGA also regulates the advertising of therapeutic goods.

The TGA is not responsible for the regulation of food, cosmetics or therapeutic goods that are not intended for use in humans (such as pet foods and veterinary medicines). These products are regulated by other Australian Government agencies.

The TGA undertakes a number of activities to ensure that therapeutic goods available in Australia meet acceptable standards of quality, safety and efficacy (effectiveness). These activities include:

registering therapeutic goods

monitoring the quality, safety and efficacy of therapeutic goods

inspecting manufacturing premises

investigating complaints

recalling therapeutic goods

prohibiting the importation of therapeutic goods

providing information and advice on therapeutic goods.

The TGA also develops and maintains a range of therapeutic goods information, including:

product information

safety alerts

recalls

publications

clinical trials

The TGA works closely with a number of other Australian and international organisations to ensure that therapeutic goods available in Australia meet acceptable standards. These organisations include:

the Australian Competition and Consumer Commission (ACCC)

the Australian Customs and Border Protection Service (ACBPS)

the Department of Agriculture and Water Resources (DAWR)

Medicines Australia

the Therapeutic Goods Administration (TGA) of New Zealand

the United States Food and Drug Administration (FDA)

the European Medicines Agency (EMA).

The TGA is also a member of the International Coalition of Medicines Regulatory Authorities (ICMRA), which is a forum for cooperation and information sharing between medicines regulatory authorities from around the world.

What are the benefits of Therapeutic Goods Association membership?

The Therapeutic Goods Association (TGA) is an Australian government organisation that is responsible for the regulation of therapeutic goods. Membership of the TGA is open to all manufacturers, importers and sponsors of therapeutic goods.

The TGA works to ensure that therapeutic goods available in Australia are of an acceptable standard and are safe and effective for their intended use. The TGA also provides information to consumers and health professionals about therapeutic goods.

Membership of the TGA provides manufacturers, importers and sponsors of therapeutic goods with a number of benefits, including:

- Access to the TGA's regulatory expertise

- A voice in the development of therapeutic goods regulation in Australia

- The ability to influence the TGA's regulatory decision-making

- early notification of proposed changes to therapeutic goods regulation

- preferential treatment in the TGA's regulatory processes.

The TGA also provides a number of benefits to consumers and health professionals, including:

- access to information about therapeutic goods

- the ability to report problems with therapeutic goods

- the opportunity to participate in the TGA's consultation processes.