We have published updated Assessed listed medicines evidence guidelines to aid sponsors in preparing their product applications. The new version has been improved based on industry feedback, consultation with the Advisory Committee of Complementary Medicines (ACCM), and our experience with applications that have been received to date.
The updated guidelines include information on the Data Protection Scheme, Comparable Overseas Body (COB) process, how to change an assessed listed medicine, and other helpful information for sponsors preparing their application. The guidelines also include changes to increase flexibility for evidence requirements and standards, as well to improve readability and clarify technical concepts.
The guidelines now provide more general information and refer to established international and TGA adopted guidelines. This means the guidelines will need less updating and align with internationally accepted standards, providing a good balance of general information with good references for sponsors who are not very familiar with this information.
Overall, the updated guidelines also include editorial and minor changes to remove repetitive information and update links to current documents, making it easier to prepare an assessed listed medicine application.
Background
The Assessed listed medicines pathway provides sponsors with a new method of listing a product in the Australian Register of Therapeutic Goods (ARTG). This pathway sits between the listed (lower risk) and registered (higher risk) pathways, enabling sponsors to list products with higher level indications without having to meet the extensive requirements for full registration.
Assessed listed medicines must have robust scientific evidence to support their efficacy, which is pre-market assessed by us. Medicines that have undergone pre-market assessment and approval by us have a unique AUST L(A) number and can carry a claim that the product’s efficacy has been assessed for the approved indications.
