where impurities information may be information may be and degradation requested by the requested by the products have been TGA. TGA. shown to be different Full pharmacology and pharmacokinetic profile Yes No No No Data to address intended action of the medicine in the context of its Yes, however if a full Yes Yes Yes incorporation into the device; and in relation to its release from the pharmacology and device at the site of action and the subsequent distribution and pharmacokinetic elimination profile is conducted that allows corollary to the use in the medical device then may not be required Clinical studies Human pharmacology including pharmacodynamics and Yes No No No pharmacokinetics Data to address intended action of the medicine in the context of its Not required if full Yes Yes Yes incorporation into the device; and in relation to its release from the human device at the site of action and the subsequent distribution and pharmacology is elimination, as a minimum provided (see previous item) Efficacy and safety studies, including adequately powered study to Yes Yes—unless Yes—unless Yes—unless demonstrate performance and safety of the medical device justification for not justification for not justification for not requiring clinical requiring clinical requiring clinical evidence is accepted evidence is accepted evidence is accepted
where impurities and degradation products have been shown to be different information may be requested by the TGA. information may be requested by the TGA. Full pharmacology and pharmacokinetic profile Yes No No No Data to address intended action of the medicine in the context of its incorporation into the device; and in relation to its release from the device at the site of action and the subsequent distribution and elimination Yes, however if a full pharmacology and pharmacokinetic profile is conducted that allows corollary to the use in the medical device then may not be required Yes Yes Yes Clinical studies Human pharmacology including pharmacodynamics and pharmacokinetics Yes No No No Data to address intended action of the medicine in the context of its incorporation into the device; and in relation to its release from the device at the site of action and the subsequent distribution and elimination, as a minimum Not required if full human pharmacology is provided (see previous item) Yes Yes Yes Efficacy and safety studies, including adequately powered study to demonstrate performance and safety of the medical device Yes Yes—unless justification for not requiring clinical evidence is accepted Yes—unless justification for not requiring clinical evidence is accepted Yes—unless justification for not requiring clinical evidence is accepted
devices-argmd-p2.docx