Therapeutic Goods Administration
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| State level | Federal level | ||
| Supervisory authority (s) | Ministry of Health | ||
| Consist | since 1989 | ||
| Headquarters | Canberra | ||
| household | AUD 139 million | ||
| Website | www.tga.gov.au | ||
The Therapeutic Goods Administration ( TGA ) is the regulatory authority for therapeutic agents (human medicinal products including traditional and herbal, as well as supplementary products such as vitamin and mineral preparations, medical devices, biopharmaceuticals and blood products) in Australia . It reports to the Australian Department of Health and was established by the Therapeutic Goods Act 1989 (Cth) . The TGA is responsible for conducting the evaluation and monitoring of the therapeutic agents available in Australia to ensure that their standards are met and that scientific advances in the therapeutic area are made available in a timely manner.
Committees of the TGA
The TGA has seven statutory advisory committees that it can convene to receive independent advice on scientific and technical issues:
- Advisory Committee on Biologicals (ACB, Advisory Committee for Biologics )
- Advisory Committee on Chemicals Schedulings (ACCS, Advisory Committee for the Classification of Chemicals )
- Advisory Committee on Complementary Medicines (ACCM, Advisory Committee for Complementary Medicine )
- Advisory Committee on Medical Devices (ACMD, Advisory Committee for Medical Devices )
- Advisory Committee on Medicals (ACM, Advisory Committee for Medicines )
- Advisory Committee on Medicals Scheduling (ACMS, Advisory Committee on the Classification of Drugs )
- Advisory Committee on Vaccines (ACV, Advisory Committee for vaccines )
There are also three other committees:
- Australian Influenza Vaccine Committee (AIVC, Australian Influenza Vaccine Committee )
- Regulatory and Technical Consultative Forum for medical devices (RegTech Forum, regulatory and technical consultative forum for medical devices )
- Therapeutic Goods Advertising Code Committee (TGACC, Committee for the Advertising Code for Therapeutic Products )
Transtasmanian harmonization
The Australian and New Zealand governments worked together to create a Trans Tasmanian drug and therapeutic agent regulator to replace the TGA and New Zealand's Medsafe . However, on July 16, 2007, New Zealand Minister Annette King announced that "the government is not currently proceeding with any legislation that would allow a joint agency with Australia to regulate therapeutic products." She also noted that “The [New Zealand] government does not have the seats in parliament to find a reasonable, acceptable compromise that would satisfy all parties at this point. The Australian Government has been informed of the situation and agrees that suspending negotiations on the Joint Authority is a sensible course of action. ”Further information has been published on the Australia New Zealand Therapeutic Products Authority (ANZTPA) website.
See also
- International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)
- List of ministries and agencies in Australia
Individual evidence
- ↑ About the TGA . Department of Health Therapeutic Goods Administration.
- ↑ About the Australian therapeutic goods legislation . Department of Health Therapeutic Goods Administration.
- ↑ Therapeutic Goods Act 1999 (Cth)
- ^ TGA statutory advisory committees. In: tga.gov.au. August 28, 2019, accessed July 11, 2020 .
- ^ Other committees. In: tga.gov.au. Retrieved July 11, 2020 .
- ↑ postponement of the ANZTPA Establishment Project. (No longer available online.) In: Anztpa.org. August 21, 2007, archived from the original on August 29, 2007 ; accessed on July 11, 2020 .