THE TGA recently unveiled the updated Assessed Listed Medicines Evidence Guidelines to make the application process for pharmaceutical product sponsors easier.
The update incorporates feedback from professionals, insights from the Advisory Committee of Complementary Medicines, and lessons learned from prior applications.
The revisions aim to enhance the flexibility of evidence requirements, improve the clarity and readability of technical information, and update procedural details such as the Data Protection Scheme and the Comparable Overseas Body process.
Notably, the guidelines now offer simplified instructions on how to modify an assessed listed medicine.
By referencing established international and TGA-adopted guidelines, the new version reduces the need for frequent updates and aligns more closely with global practices.
The approach benefits sponsors who are less familiar with such regulations by balancing detailed guidance with accessible references.
Additionally, the updated guidelines have been streamlined to eliminate redundant information, simplifying the application process for entering medicines into the Australian Register of Therapeutic Goods under the assessed listed pathway.
The pathway allows sponsors to market products with high-level indications without the need for the full registration's extensive requirements.
The above article was sent to subscribers in Pharmacy Daily's issue from 17 Apr 24
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 17 Apr 24
