Navigating TGA Australia Drug Registration and Compliance

DDReg Knowledge Capsule · Jul 3, 2026 · 25m

This episode provides a comprehensive guide to the Therapeutic Goods Act 1989, exploring the various pathways for getting prescription medicines onto the Australian Register of Therapeutic Goods (ARTG). We dive into the differences between Standard, Verification, and Priority Review pathways, while highlighting the critical importance of Australian-specific documentation, such as the Australian Specific Annex (ASA) for Risk Management Plans. Listeners will also learn how to avoid common registration pitfalls—including GMP clearance gaps and PI/CMI non-compliance—to ensure a more efficient and…