TGA (Therapeutic Goods Administration)

Who regulates medicines in Australia?

In one sentence

The TGA is Australia's regulator of medicines, devices and other therapeutic goods: a part of the health department that bills industry for its work.

It sits inside the Department of Health, Disability and Ageing, keeps the Australian Register of Therapeutic Goods (ARTG), and must by law recover its costs through fees and charges. Sponsors send it serious Australian cases within 15 days and significant safety issues within 72 hours.

Where it sits

DepartmentDepartment of Health, Disability and Ageing
GroupHealth Products Regulation Group (HPRG)
RegulatorTGA, which keeps the ARTG and recovers its costs
ReportsDatabase of Adverse Event Notifications (DAEN)Public, with reports back to 1971

Think of it like this

Think of a lifeguard tower paid for by the beach clubs it watches. The council owns it, the clubs pay the wages, and the lifeguard still blows the whistle at them.

Key insights

Inside the department, paid by industry15 days, 72 hoursThe black triangleLeaning on friends

The TGA is a part of the health department, not a separate agency, born in August 1989 under the Therapeutic Goods Act it administers. The law requires it to recover its costs through fees and charges, public health work included. Chapter 1 tells how.

A serious adverse reaction that occurred in Australia reaches the TGA within 15 calendar days of the sponsor learning of it. A significant safety issue has 72 hours, any other safety issue 30 days. Non-serious and overseas cases are not sent one by one at all; they wait for the periodic safety update report. Chapter 2 sets the clocks.

Since the start of 2018 new prescription medicines carry a black triangle on their product and consumer information for at least five years, as a condition of registration. The TGA copied the idea from Europe and the United Kingdom.

The TGA often relies on assessments by comparable overseas regulators. It reviews cancer medicines jointly through Project Orbis, shares work in the Access Consortium with Canada, Singapore, Switzerland and the United Kingdom, and sits in the International Coalition of Medicines Regulatory Authorities (ICMRA).

Jump to: 1 Three moments 2 Your report, their clock 3 Side by side with Europe 4 Test yourself

Chapter 1

Which three moments made the TGA what it is?

Pick a year. Each set a habit the TGA still has.

1989An Act, a register and a bill2018The black triangle arrives2021A year of 112,000 reports

An Act, a register and a bill

Australia had controlled medicines in pieces since colonial days: a Therapeutic Substances Act in 1937, a national serum laboratory before that. The Therapeutic Goods Act 1989 gathered the pieces into one framework, and in August 1989 the TGA emerged inside the health department to run it.

Two habits came with the Act. The TGA keeps the Australian Register of Therapeutic Goods, and nothing may be lawfully supplied unless it is on it. And the law tells the TGA to recover its costs through fees and charges.

What it left behind: a regulator that lives inside a ministry but is paid by the companies it regulates.

The black triangle arrives

At the start of 2018 the TGA began printing a black triangle on the product and consumer information of new prescription medicines, and of old ones approved for new uses. A similar scheme runs in Europe and the United Kingdom. The symbol stays for at least five years from first supply and is imposed as a condition of registration under section 28(2B) of the Act.

The same conditions power is what lets the TGA demand periodic safety update reports, and sections 29A and 29AA of the Act oblige a sponsor to write in as soon as it learns its medicine may have an unintended harmful effect. The sponsor guidance built on this follows the EU’s good pharmacovigilance practice module on adverse reactions, with Australian exceptions.

What it left behind: a symbol that asks for reports, and a rulebook that reads like Europe’s with local clocks.

A year of 112,000 reports

When the coronavirus vaccine rollout began in 2021 the TGA published a safety report every week. The 52nd issue, in March 2022, summed up the first year: 54 million doses given and just over 112,000 suspected adverse event reports received, the most intensive safety monitoring of any vaccine in Australia.

By the last regular issue, on 2 November 2023, almost 69 million doses had been given, and the TGA had reviewed 1,004 reports of death and linked 14 of them to vaccination, none after 2022. The reports went where every Australian report goes: into the public Database of Adverse Event Notifications.

What it left behind: the habit of publishing the count, in public, every week.

Chapter 2

Your report, their clock

A case has reached your company. The sponsor guidance sets the deadline with two questions: is it serious, and did it happen in Australia? Pick a cell.

In AustraliaOverseasSeriousSerious, hereSerious, abroadNot seriousNot serious, hereNot serious, abroad

Or it is not a single case: a significant safety issue or another safety issue

A serious adverse reaction that occurred in Australia, expected or not, goes to the TGA within 15 calendar days of the day anyone in your company first held the four minimum data elements. On the international CIOMS form (Council for International Organizations of Medical Sciences), through the Adverse Event Management System, or by E2B. TGA sponsor guidance; Therapeutic Goods Act 1989, section 28(5)(e)

Non-serious cases and overseas cases are not sent one by one. They go into the periodic safety update report the TGA can require as a condition of registration, or come when the TGA asks. TGA sponsor guidance; Therapeutic Goods Act 1989, section 28(2B)

A significant safety issue, such as a comparable overseas regulator withdrawing the medicine or adding a boxed warning, is notified within 72 hours of awareness through the online safety issues form. TGA sponsor guidance; Therapeutic Goods Act 1989, sections 29A and 29AA

Any other safety issue has 30 calendar days from awareness, and so does each piece of follow-up. TGA sponsor guidance

You must report all serious adverse reactions that occur in Australia as soon as possible and no later than 15 calendar days from receipt.
TGA, Pharmacovigilance responsibilities of medicine sponsors: the one hard clock for single cases

Doctors and patients have no clock and no duty: anyone can report, and the report lands in the Database of Adverse Event Notifications, public two weeks later. One clock runs before any case: within 15 days of its first entry on the register a sponsor must name a pharmacovigilance contact person living in Australia.

Chapter 3

Side by side with Europe

The TGA says its rulebook is mostly consistent with the European Union’s (EU). Five places where it is not.

	The EU rule	The Australian rule
Who decides	The European Commission, on the opinion of the European Medicines Agency (EMA), for centralised medicines	The TGA, inside the department, often relying on a comparable overseas regulator
Where a serious case goes	EudraVigilance within 15 days, wherever it happened	The TGA within 15 calendar days, but only cases that occurred in Australia
A non-serious case	90 days if it happened in the Union	No single-case report; it waits for the periodic safety update report
A safety issue	Assessed at the EMA’s safety committee	The sponsor notifies the TGA itself: 72 hours if significant, 30 days otherwise
The black triangle	Medicines on the additional monitoring list carry it	New prescription medicines carry it for at least five years as a condition of registration, since 2018

Show the legal references

Who decides: Regulation (EC) No 726/2004, Article 10(1); TGA, Our regulatory framework and International engagements.
Serious cases: Directive 2001/83/EC, Article 107(3); TGA sponsor guidance, table 1; Therapeutic Goods Act 1989, section 28(5)(e).
Non-serious cases: Directive 2001/83/EC, Article 107(3); TGA sponsor guidance, table 1; Therapeutic Goods Act 1989, section 28(2B).
Safety issues: TGA sponsor guidance; Therapeutic Goods Act 1989, sections 29A and 29AA.
Black triangle: Regulation (EC) No 726/2004, Article 23; TGA, The Black Triangle Scheme.

Europe’s rulebook with two Australian edits: only Australian cases count as single reports, and the sponsor rings the alarm itself, within 72 hours.

The facts, in one place

What it is	A part of the Department of Health, Disability and Ageing, in its Health Products Regulation Group; it administers the Therapeutic Goods Act 1989 and keeps the register.
Since	August 1989, under the Act of the same year.
Who decides	The TGA itself, as a division of the department; statutory advisory committees support it.
Seat	Canberra (Woden, Australian Capital Territory).
Money	Required by law to recover its costs through fees and charges, public health work included.
The vaccine years in numbers	54 million doses and just over 112,000 suspected adverse event reports in the first year; almost 69 million doses by October 2023; 14 deaths linked to vaccination from 1,004 reviewed.
Member of	The Access Consortium with Canada, Singapore, Switzerland and the United Kingdom; the International Coalition of Medicines Regulatory Authorities (ICMRA); the Pharmaceutical Inspection Co-operation Scheme (PIC/S), in the convention since 1993 and the scheme since 1995; Project Orbis; an observer at the International Council for Harmonisation (ICH).

Don’t confuse it with: the Pharmaceutical Benefits Advisory Committee (PBAC)

TGA

The regulator

Decides: whether a medicine is safe, effective and of good enough quality to be supplied
Is: a part of the health department, funded by industry fees
Example: enters a new medicine on the register with a black triangle

PBAC

The payer’s adviser

Recommends: which medicines the Pharmaceutical Benefits Scheme should subsidise; no listing without its yes
Is: an independent expert body appointed by the Government, meeting three times a year
Example: judges whether that registered medicine is worth the taxpayer’s money

Chapter 4

Test yourself

Myth or Truth? Pick an answer to see the explanation.

“A sponsor must send the TGA every non-serious Australian case within 90 days.”

MythTruth

MythYou got it.Not quite.

That is the EU clock. In Australia non-serious and overseas cases are not sent one by one; they go into the periodic safety update report or come on request. Only serious Australian cases have the 15-day clock.

“A significant safety issue must reach the TGA within 72 hours.”