Summary
Therapeutic Goods Amendment Regulations 2003 (No. 1) amended the Therapeutic Goods Regulations 1991, which govern the registration, listing, manufacturing standards, advertising, and import/export controls for medicines, medical devices, and other therapeutic products in Australia. The instrument would have introduced changes to compliance requirements, product classification, approval pathways, or regulatory fees for therapeutic goods.
Reason
Therapeutic goods regulation exemplifies the regulatory burden that harms Australian prosperity and liberty. The TGA regime creates multi-year approval timelines, billions in compliance costs, and barriers that protect incumbent pharmaceutical giants from competition. Consumers face higher prices and delayed access to treatments. Product safety can be adequately addressed through tort liability and market-based certification rather than bureaucratic pre-approval. This amendment perpetuates a system that stifles innovation, entrenches large players, and exercises paternalistic control over what Australians can buy and sell in the therapeutic marketplace.