science

Therapeutic Goods Administration

Therapeutic Goods Administration is a science topic covered in the lgStudy science library. This page brings together a partial reference excerpt, illustrations, worked examples, real-world applications and a short study plan, so you can understand Therapeutic Goods Administration rather than just read about it. In short: The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health, Disability and Ageing, the TGA regulates the safety, quality, efficacy and advertising in Australia of therapeutic goods (which comprise medicines, medical devices, biologicals and certain other therapeutic goods).

Key takeaways

Therapeutic Goods Administration belongs to science; place it in that map before memorising details.
Learn the definition first, then one example that makes the definition concrete.
Connect Therapeutic Goods Administration to a quantity you can measure, compute or draw — that is where exam questions come from.
Reproduce the core statement of Therapeutic Goods Administration from memory before moving on to harder problems.

Reference excerpt

The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health, Disability and Ageing, the TGA regulates the safety, quality, efficacy and advertising in Australia of therapeutic goods (which comprise medicines, medical devices, biologicals and certain other therapeutic goods). Therapeutic goods include goods that are represented to have a therapeutic effect, are included in a class of goods the sole or principal use of which is (or ordinarily is) a therapeutic use, or are otherwise determined to be a therapeutic good through a legislative instrument under the Therapeutic Goods Act 1989. Goods that are therapeutic goods must be entered on the Australian Register of Therapeutic Goods (ARTG), or otherwise be the subject of an exemption, approval or authority by the TGA under the Therapeutic Goods Act 1989, Therapeutic Goods Regulations 1990 or Therapeutic Goods (Medical Devices) Regulations 2002 before they can be imported, supplied, exported or manufactured in Australia.

History

Early years Regulation of therapeutic goods in Australia was initially undertaken at a state level, with regular conferences held between state and federal governments aimed at achieving uniform standards for drugs. Although federal legislation was sought from an early period, there was considerable uncertainty as to the extent of the federal parliament's ability to legislate in that area. Commonwealth Serum Laboratories was created by the federal government in 1916 and in 1932 was nominated as the local repository for biological standards set by the League of Nations. The first federal legislation relating to therapeutic goods was the Lyons government's Therapeutic Substances Act 1937, which gave the federal Minister for Health the power to regulate the import and export of therapeutic goods and bring Australian standards into line with League of Nations standards. The act was amended in 1938 to better define which substances were therapeutic. Ultimately the provisions of the legislation was never brought into effect due to changes of government and the onset of World War II. The National Health and Medical Research Council (NHMRC) took a more active role in co-ordinating regulation during war time, including uniformity of labelling, medical nomenclature, and dangerous drugs legislation.

First federal legislation In 1952, following lobbying from the NHMRC, the federal government organised a Therapeutic Substances Conference attended by representatives of federal and state governments. The conference passed a series of resolutions calling on major changes to therapeutic goods regulation in Australia, including national legislation for drug purity standards, uniform state legislation for drug manufacture, marketing and labelling, and the establishment of a national standards laboratory for testing new drugs. It has been suggested the increased focus on national standards was prompted by concerns that the Pharmaceutical Benefits Scheme (PBS) was allowing for government subsidy of sub-standard medicines. The Menzies government's Therapeutic Substances Act 1953, passed in the wake of the National Health Act 1953, was the first effective federal therapeutic goods legislation and allowed for federal control over drug imports, drug sold to the federal government, drugs subject to interstate trade, and drugs supplied under the PBS. The new act allowed for the replacement of the British Pharmacopoeia (BP) as the primary source of quality standards for drugs in Australia, following concerns that the BP had not kept up to date with new medications. In introducing the legislation, federal health minister Earle Page – a former surgeon – referred to the existing poor standard of drug quality in Australia and stated it "would be criminal to allow such a state of affairs to exist and continue merely through lack of appropriate action". In 1956, regulations under the 1953 act established the Therapeutic Substances Advisory Committee, the Biological Standards Committee, and the Therapeutic Substances Standards Committee to advise the Minister for Health on drug regulations. The National Biological Standards Laboratory (NBSL) was created in 1958 to test the quality of imported drugs and drugs to be supplied under the PBS. One notable absence from the 1953 legislation was the lack of any penalty for possessing or dealing with a sub-standard therapeutic substance.

Regulatory expansion The Thalidomide scandal of the early 1960s prompted a reconsideration of federal regulation of drugs. In 1963, the Australian Drug Evaluation Committee was formed to consider legislative reforms and expressed its "grave concern at the continuing lack of adequate statutory control over the importation of new therapeutic substances". The committee's lobbying resulted in the Therapeutic Goods Act 1966, which significantly expanded the Minister for Health's powers in that area. However, regulations under the 1966 act were not proclaimed until 1970, amid significant criticism that the act gave the minister too much power and reduced parliamentary oversight. The new legislation also failed to resolve the issue of uniform state regulations. A separate Therapeutic Substances Section was created in the Department of Health in 1963, under the Division of National Health, with regulations having previously been overseen by the director of the NBSL. The National Therapeutic Goods Committee was established in 1971 and in 1974 the Department of Health was restructured to create a separate Therapeutics Division in place of the Therapeutic Substances Section. The NBSL was merged into the Therapeutics Division in 1985. In 1981, the Fraser government's Health Acts Amendment Bill 1981 significantly broadened the scope of the Therapeutic Goods Act 1966 to include a wide range of medical devices, update standards and monitoring of manufacturing and testing, established a new National Register of Therapeutic Goods, and increase penalties for contraventions of the act.

… excerpt ends here. Continue reading the full article.

Illustrations

Wordmark of the Australian Government's COVID-19 vaccination program.

Worked examples

Example 1 — a first encounter with Therapeutic Goods Administration

Start with the simplest possible case. Write down what Therapeutic Goods Administration claims or describes in one sentence, then invent the smallest concrete situation in which that sentence is true. In science, the smallest case is usually a single object, a single equation or a single measurement. Check that every symbol or term in your sentence has a meaning in that case.

Example 2 — changing one variable

Take the situation from Example 1 and change exactly one quantity: double it, halve it, or set it to zero. Predict what should happen to Therapeutic Goods Administration before you calculate. Comparing your prediction with the result is the fastest way to find out whether you understand the idea or only the words.

Example 3 — an exam-style question

Typical questions about Therapeutic Goods Administration ask you to (a) state it precisely, (b) apply it to given data, and (c) explain a limitation. Practise writing all three answers in under five minutes; the third part is what separates a full-mark answer from an average one.

Applications of Therapeutic Goods Administration

In research: Therapeutic Goods Administration appears in science research whenever the underlying quantities have to be modelled precisely. Papers usually cite it as a starting assumption and then explore where it breaks down.
In technology and industry: Engineering practice reuses Therapeutic Goods Administration in design rules, simulations and safety margins. Knowing the idea lets you read a specification sheet and understand why the numbers look the way they do.
In the classroom: Therapeutic Goods Administration is common in secondary-school and first-year university syllabi. It links to neighbouring topics 1989 establishments in Australia, Commonwealth Government agencies of Australia, Government agencies established in 1989, so understanding it makes those chapters shorter.
In everyday life: Look for Therapeutic Goods Administration outside the textbook — in sport, cooking, traffic, electronics or the sky above you. An example you found yourself is remembered far longer than one you were given.

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How to study Therapeutic Goods Administration in 20 minutes

Read the reference excerpt below once, without taking notes.
Close the page and write down what Therapeutic Goods Administration means in your own words.
Compare your version with the excerpt and mark what you missed.
Work through the three examples above with pen and paper.
Explain Therapeutic Goods Administration out loud to somebody else — or to Teacher Smith in the lgStudy chat.

Frequently asked questions

What is Therapeutic Goods Administration in simple terms?

Why does Therapeutic Goods Administration matter?

Because it connects several science ideas at once: it gives you a definition you can apply, a quantity you can calculate, and a way to check whether a result is plausible.

How should I study Therapeutic Goods Administration?

Read the excerpt, restate it from memory, then work through the examples and applications listed on this page. The five-step study plan above takes about twenty minutes.

What does this page cover?

It gives you a compact reference excerpt plus original lgStudy explanations, examples, applications and study material on Therapeutic Goods Administration.