[8] 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.

[11] Ultimately the provisions of the legislation was never brought into effect due to changes of government and the onset of World War II.

[14] 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.

[20] 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".

[21] The committee's lobbying resulted in the Therapeutic Goods Act 1966, which significantly expanded the Minister for Health's powers in that area.

The TGA also includes seven specialised statutory committees, which the agency can call upon for assistance on technical or scientific issues.

[30] Four other committees also exist to give guidance on annual influenza vaccines, industry consultation matters, and the Therapeutic Goods Advertising Code.

[31] In September 2003, the Australian and New Zealand Government signed a treaty to establish a common therapeutic regulatory agency for the two countries.

[32] In November 2014, both Australia and New Zealand agreed to cease plans to create a shared regulator, citing "a comprehensive review of progress and assessment of the costs and benefits to each country".

[34] Additionally, every batch of vaccines have their composition and documentation verified by TGA laboratories before being distributed to medical providers.

[46] On 23 March, TGA approved the first batch of locally manufactured AstraZeneca vaccine by CSL-Seqirus in Melbourne, and 832,200 doses were ready for rollout in the following weeks.

[47] On 17 June 2021, Federal Health minister Greg Hunt announced a rise in the age limit for administration of the AstraZeneca vaccine.

After new advice from the Australian Technical Advisory Group on Immunisation (ATAGI), the vaccine was no longer recommended for people aged under 60 years.

Strict conditions were imposed on Janssen which includes further investigation documents related to the efficacy, long term effects and safety concerns that must be provided regularly to TGA.