AUSTRALIA Law and Practice Contributed by: Greg Williams and Sheena McKie, Clayton Utz
review under the Administrative Decisions (Judicial Review) Act 1977 (the “ADJR Act”) or under Section 39B of the Judiciary Act 1903. Judicial review is differ- ent to merits review, and is an examination of whether decision was made lawfully – that is, whether the pro- cess by which the decision was made was lawful, fair and reasonable, rather than whether the correct deci- sion was in fact made. Judicial review procedures (in contrast to the mer- its review procedures) may be available in respect of government decision-making by any level of govern- ment, unless the decisions are expressly excluded from such review. Judicial review is often considered in respect of Ministerial decisions relating to the Phar- maceutical Benefits Scheme, or steps preparatory to the making of such decisions (eg, recommendations by the Pharmaceutical Benefits Advisory Committee). Food products are regulated by reference to the Food Standards Code, which are given legal status by appli- cation laws in each state and territory. The state Food Authorities are the regulatory bodies for those stand- ards. 1.3 Categories of Pharmaceuticals and Medical Devices Australia uses a risk-based tiered system for regulat- ing therapeutic goods. The level of risk associated with a particular category of product will dictate the application pathway for inclusion on the ARTG, as well as what evidence is required to be held or provided to the TGA to achieve a listing. The higher the classifica- tion, the more rigorous the pre-market assessment will be. Low-risk medicines (most vitamins and supplements) are simply listed on the ARTG based on sponsor self- certification, while higher-risk medicines (prescription drugs, over-the-counter (OTC) medicines) may only be registered after a full TGA evaluation of safety, quality and efficacy. In addition, substances (including in cer- tain forms or concentrations) may be “scheduled” by being included on the Poisons Standard. The Poisons Standard is a legislative instrument that classifies sub- stances (again by risk) into “Schedules”, including Schedule 2 (Pharmacy Only), Schedule 3 (Pharmacist Only), Schedule 4 (Prescription Only) and Schedule
8 (Controlled Substances). Scheduling also impacts storage and handling requirements (governed by state and territory legislation). Unscheduled (or General Sale) Medicines Unscheduled medicines have been determined to be suitable for supply without supervision by a qualified healthcare professional and are available for general sale (such as in supermarkets). Sometimes, these medicines will be a smaller pack size or lower dos- age than other scheduled medicines. Medical devices are subject to a separate classifica- tion framework with risk tiers ranging from Class I (low-risk items such as bandages, largely self-certi- fied) through to Class III (high-risk items such as heart valves or other implantable devices, requiring more detailed assessment by the TGA). A parallel four-class system assesses in vitro diagnostic devices. Clinical trials of unapproved therapeutic goods in Aus- tralia are regulated by the TGA under the Therapeutic Goods Act 1989 (Cth) and associated regulations, including the Therapeutic Goods Regulations 1990 (Cth) and the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth). More specifically, unapproved therapeutic goods (including pharmaceuticals and medical devices) are exempt from the requirement to be listed, registered or included on the ARTG where those goods are being supplied for use in a clinical trial solely for experimen- tal purposes in humans and where such supply is subject to oversight by the TGA via either the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) pathway. Unapproved goods also include therapeutic goods which are included in the ARTG but which will be used in a manner not covered by the existing ARTG entry during the clinical trial. 2. Clinical Trials 2.1 Regulation of Clinical Trials The regulatory framework applies to medicines, bio- logicals and medical devices, and is supported by ethical and governance requirements at the institu- tional level. Clinical trials must comply with:
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