Assessed listed medicines guidelines

In March 2018 the TGA implemented a new assessed listed medicines pathway under Section 26AE of the Therapeutic Goods Act 1989 (the Act).

The assessed listed medicines pathway implements one of the Government's reforms to the regulatory framework for complementary medicines arising from the Medicines and Medical Devices Regulation Review (MMDR).

The 'assessed listed medicines' pathway sits between the current listed (lower risk) and registered (higher risk) pathways. Medicines listed through the assessed listed medicines pathway will be included in the ARTG following self-certification of the safety and quality of the product, and TGA pre-market assessment of efficacy evidence supporting the proposed indications.

For more information on the assessed listed medicines pathway see Assessed listed medicines pathway for complementary medicines.

Guidance on the regulatory and submission dossier requirements for assessed listed medicines is provided below.

Assessed listed medicines evidence guidelines

Guidance on the evidence requirements and submission process is provided below

• Assessed listed medicines evidence guidelines

Assessed listed medicines submission dossier requirements

• CTD Module 1: Administrative information for assessed listed medicines
• Mandatory requirements for an assessed listed medicine application

Completing the application form

• Guidelines for completing the application