delete Therapeutic Goods Regulations (Amendment)
Amendment to the Therapeutic Goods Regulations governing the registration, listing, manufacturing standards, import/export, advertising, and post-market surveillance of therapeutic goods (medicines, medical devices, biologics) in Australia, administered by the Therapeutic Goods Administration.
Therapeutic goods regulation creates substantial barriers to entry for pharmaceutical and medical device businesses, inflates compliance costs that are passed to consumers, delays access to life-improving treatments, and protects incumbent manufacturers from competition. The TGA regime exemplifies regulatory duplication with state-level requirements. While noting legitimate concerns about product safety, equivalent consumer protection can be achieved through private certification, tort liability, and market mechanisms rather than central administrative approval processes. The compliance burden falls disproportionately on smaller manufacturers and生物 technology startups, reducing dynamism in the sector. The case for deletion rests on: (1) approval timelines delaying access to superior treatments, (2) compliance costs adding billions in drug/device costs, (3) barriers protecting large incumbent manufacturers, (4) information asymmetries are better addressed through disclosure requirements rather than prior approval, and (5) post-market surveillance and liability law can address safety concerns more efficiently than pre-market bureaucratic screening.