Summary
Amendment to Therapeutic Goods Regulations governing the approval, manufacture, import, export, and supply of therapeutic goods (medicines, medical devices, biologicals) in Australia. Establishes TGA approval processes, Good Manufacturing Practice requirements, adverse event reporting, and compliance enforcement mechanisms.
Reason
Therapeutic goods regulation exemplifies regulatory capture and barriers to entry that harm Australians. The TGA approval process takes years and costs hundreds of millions per product, delays access to life-saving treatments available overseas, and imposes compliance costs ultimately borne by patients. Such central planning of drug and device approval substitutes bureaucratic judgment for individual choice and physician expertise— Hayek's information problem. Established pharmaceutical and medical device companies benefit from these barriers as de facto monopolies, while patients, especially those with rare diseases or in rural areas, suffer from delayed access. The intended goals (safety, efficacy) can be better achieved through tort liability, voluntary certification, and market reputation mechanisms that don't concentrate power or create chronic approval delays.