Document ID: chunk:federal_register_of_legislation:F2022C00752:reg:4:p1
Version: federal_register_of_legislation:F2022C00752
Segment Type: reg
Provision Reference: reg 4 (pt 1/2)
Character Range: 2681–5760

4  Definitions
Note:  A number of expressions used in this instrument are defined in the Industry Research and Development Act 1986 by reference to definitions in Division 355 of the Income Tax Assessment Act 1997, including the following:
(a) core R&D activities;
(b) R&D entity.
  In this instrument:
biological has the same meaning as in section 32A of the Therapeutic Goods Act 1989.
biosimilar medicine means a version of an already-registered biological medicine. These medicines may be referred to as similar biological medicinal products, similar biotherapeutic products, subsequent entry products, bioequivalents, or follow-on products. Both the biosimilar and its reference medicine will have the following similar characteristics (demonstrated using comprehensive comparability studies): physicochemical, biological, immunological, efficacy and safety.
generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):
 (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and
 (b) has the same pharmaceutical form; and
 (c) is bioequivalent; and
 (d) has the same safety and efficacy properties.
phase 0 clinical trial (human pharmacology (micro-dosing)) means a clinical trial that involves dosing a limited number of humans with a limited range of doses of a medicine or biological for a limited period of time with the objective of:
 (a) assessing pharmacokinetics; and
 (b) gathering preliminary data on pharmacokinetics and bioavailability to determine if the drug behaves as expected from preclinical 'micro-dosing' studies.
phase I clinical trial (human pharmacology) means a clinical trial that involves the first administration to humans of a medicine or biological with the objective of assessing its safety and tolerance. Such trials typically include defining or describing pharmacokinetics and pharmacodynamics; determining dosing; exploring drug metabolism and drug interactions; and identifying preferred routes of administration. Trials may be phase Ia or phase Ib as follows:
 (a) phase Ia: a clinical trial that involves a single ascending dose;
 (b) phase Ib: a clinical trial that involves multiple ascending doses.
phase II clinical trial (therapeutic exploratory) means a clinical trial undertaken in a larger group of human patients with the objective of evaluating the efficacy and safety of a medicine or biological. Trials may be phase IIa or phase IIb as follows:
 (a) phase IIa: a clinical trial to demonstrate clinical efficacy or biological activity through pilot studies and to explore therapeutic dose range;
 (b) phase IIb: a clinical trial to determine optimum therapeutic dose and regimen (with efficacy as the primary endpoint); and to resolve uncertainties regarding the design and conduct of subsequent trials.
phase III clinical trial (therapeutic confirmatory) means a clinical trial that involves a large