Chapter 1 Australian TGA Regulatory information brief

1. Eaa and Introduction

The TGA of Australia is responsible for the regulation of health products (called complementary medicines in the definition of the TGA of Australia), including risk classification management, quality, safety and efficacy assessment.

2. Supervision and regulation

Therapeutic Goods Act 1989

Therapeutic Goods Regulations 1990

3. Australian classification of health products

Australia classifies health products as complementary medicines（Complementary Medicines），According to the different raw materials and claims, it is divided into registered and registered supplementary drugs. Registered supplements are further divided into Registered Supplements (AUST L) and evaluated registered supplements（AUST L(A)）。

Pharmaceutical products containing ingredients such as herbs, vitamins, minerals, nutritional supplements, homeopathic remedies, and certain aromatherapy preparations are called "complementary medicines" and are regulated as medicines under the Act. Complementary drugs may be listed or registered, depending on their ingredients and the claims of the drug. Most complementary drugs are listed on ARTG, and it is very difficult to register supplementary drugs.

4. Entry requirement

• GMP

• Power of attorneyandSponsor Message

• Total component、Label and packaging

• Test report (Physicochemical, microbiological)andValidity data

• Manufacturer and product information

• warn
  

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5. Registration language 

    English

Chapter 2 Registration process, cycle & Government fee

1. Registration flow chart

1）Food and drug classification

2）Determine the registration and registration path

2. Registration period and official fees

1）Registration cycle

Registration supplementary drugs can be completed after the system submission and payment; The pre-examination notice of registered supplementary drugs is40 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）

Chapter 3 FAQ 

Q：Whether the information can be changed after the registration of supplementary drugs in Australia？

A：Content that meets the requirements may be changed, and the change process will incur additional costs.

Q：What is the regulatory definition of complementary medicines in Australia？

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).