Summary
Amendment to Therapeutic Substances Regulations 1958, regulating the manufacture, import, export, and supply of therapeutic substances including drugs, medicines, and medical devices. Establishes licensing requirements, quality standards, and compliance obligations for therapeutic goods operators.
Reason
The 1956 regulatory framework, even as amended, imposes licensing barriers that restrict market entry for pharmaceutical manufacturers and suppliers. Compliance costs are passed to consumers, contributing to Australia's high medication prices. Approval timelines delay access to treatments. State and federal duplication creates a compliance maze. Modern risk-based regulatory approaches (like the TGA's existing framework) can achieve safety objectives more efficiently without the significant deadweight costs of this older regulatory regime.