Registered medicines are classified as high risk and low risk. The high-risk ones are assessed individually for quality, safety and efficacy and should be manufactured under GMP. The low-risk ones are listed medicines and contain ingredients permitted by the TGA for use in low-risk medicines restricted to indication and claims relating to health maintenance, health enhancement or non-serious, self-limiting conditions. These are not assessed individually for efficacy, but must certify to the TGA that they hold evidence to support all indications and claims made for their products. These too should be manufactured under GMP and require post-market regulatory activities, including reporting of adverse reactions, audit of manufacturers and laboratory testing.


Leave a Reply

Your email address will not be published. Required fields are marked *