TGA & PMDA Labelling Explained: Ultimate Guide to Regulatory Compliance in Australia and Japan Mastering TGA and PMDA Labelling: Compliance-Driven Guide for Pharma Submissions Introduction to TGA & PMDA Labelling and Its Importance Labelling in Australia and Japan is regulated by the Therapeutic Goods Administration (TGA) and the Pharmaceuticals and Medical Devices Agency (PMDA) respectively. Both agencies ensure that drug labelling provides clear, accurate, and accessible information for healthcare professionals and patients. In Australia, labelling includes the Product Information (PI) and Consumer Medicine Information (CMI), while in Japan, it includes the Package Insert (PI) and patient-facing leaflets. These documents form…