Australia

Pharmacovigilance for medicines in Australia is regulated by the Therapeutic Goods Administration (TGA). Sponsors must maintain an effective pharmacovigilance system and nominate an Australian Pharmacovigilance Contact Person (A-PVCP) who resides in Australia; the A-PVCP details must be provided to the TGA within 15 calendar days of the sponsor's first medicine entry on the ARTG and updated within 15 calendar days of changes. Serious adverse reactions occurring in Australia must be reported within 15 calendar days, significant safety issues within 72 hours, and other safety issues within 30 calendar days. The TGA recommends, but does not legally require, a Qualified Person Responsible for Pharmacovigilance in Australia (QPPVA); ideally the QPPVA and A-PVCP are the same person. PSURs and RMPs apply when required by the TGA or as a condition of registration, rather than as universal submissions for every medicine. The Australian framework does not establish an EU-style QPPV or PSMF requirement. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.