The TGA requires thorough evaluation of all therapeutic products before market entry. This includes clinical trials, laboratory testing, and manufacturing process reviews to verify safety, quality, and efficacy. Products must be registered in the Australian Register of Therapeutic Goods (ARTG) before legal distribution.

Australia employs a risk-based methodology, applying greater scrutiny to higher-risk therapeutic goods. This ensures optimal resource allocation while maintaining oversight across all product categories. TGA decisions are grounded in scientific evidence and expert consultation from specialized committees and international regulatory partners.

The TGA licenses and monitors both domestic and international manufacturers through comprehensive inspections and audits. All facilities must comply with Australia's Good Manufacturing Practice (GMP) standards, ensuring pharmaceutical supply chain integrity and consistent product quality.

The TGA conducts continuous monitoring after product approval to identify emerging safety concerns. This system includes adverse event reporting, product quality reviews, and safety evaluations. When concerns arise, the TGA has authority to implement regulatory actions including recalls or market withdrawal.