TGA Seeks Comment on Complementary Medicine Pathway Improvement Plans

Australia’s Therapeutic Goods Administration is soliciting feedback on planned process improvements for its pathway for complementary medicines approval.

Regulators plan to reform complementary medicine assessment pathways in response to a 2015 expert panel review and is seeking industry feedback on its plans, which include creating a third class of products. The agency is requesting comments focusing on evidence, processes and timeframes.

To enable increased use of overseas regulatory exports, TGA has also proposed creating four application categories, ranging from those processed by TGA based solely on reports from overseas regulators to applications that need a full de novo safety and quality evaluation.