The Therapeutic Goods Administration (TGA) of Australia is responsible for the regulation of health products, which are defined as complementary medicines under the TGA’s regulatory framework. Its regulatory scope covers risk-based classification management, quality control, safety assessment and efficacy evaluation, among other functions.
Official Website of the Regulatory Authority: https://www.tga.gov.au/
Database Portal (Australian Register of Therapeutic Goods, ARTG): https://compliance.health.gov.au/artg/
Therapeutic Goods Act 1989
Therapeutic Goods Regulations 1990
GMP
Power of attorney and Sponsor Message
Total component、Label and packaging
Test report (Physicochemical, microbiological) and Validity data
Manufacturer and product information
warn
English
1）Food and drug classification
2）Determine the registration and registration path
1）Registration cycle
Registration supplementary drugs can be completed after the system submission and payment; The pre-examination notice of registered supplementary drugs is 40 working days, and the assessment time will be increased with the risk level, the lowest risk of 45 working days, the highest risk of 310 working days.
2）Government fee
A. Registered supplementary drugs（AUST L）
B. Evaluation and registration of supplementary drugs（AUST L(A)）
C. Registered supplementary drugs（AUST R）
A：Content that meets the requirements may be changed, and the change process will incur additional costs.
A：A complementary medicine is a therapeutic product consisting wholly or primarily of one or more designated active ingredients, each of which has clearly defined properties and traditional uses. For adjunctive drugs, a designated active ingredient means one or more of the active ingredients mentioned in Schedule 14 (Regulation).