AUSTRALIA Law and Practice Contributed by: Greg Williams and Sheena McKie, Clayton Utz
and public interest tests are met, subject to HREC approval. Disclosures to CROs, service providers and affiliates must be documented and controlled. Cross-border disclosures require reasonable steps to ensure that overseas recipients protect personal information con- sistently with the APPs and engage accountability for offshore disclosures. Appropriate contractual, techni- cal and organisational measures should be in place, and de-identified datasets should be used where fea- sible. 2.6 Personal or Sensitive Data Creating a database that contains personal or sen- sitive information will be required to meet minimum requirements set out in the Privacy Act. Patient con- sent forms supporting the creation and use of such a database will be important to what additional require- ments will be needed. The Australian Privacy Princi- ples impose a range of obligations, including to: • maintain a clear, up-to-date privacy policy and pri- vacy management plan, assign accountability, and embed privacy by design; • collect only what is reasonably necessary for the research and related operational purposes; • implement proportionate technical and organisa- tional security controls, vendor due diligence and access management; and • establish retention schedules and destroy or de-identify personal information when no longer required.
The following key points are relevant for the assess- ment process: • classification is the responsibility of the medicine or device manufacturer – however, the sponsor will be required to make the application and to make certain certifications to the TGA; • the TGA provides online decision tools to guide sponsors through the process, and sponsors can also consult the TGA directly for novel or ambigu- ous products; and • for medical devices, the manufacturer assigns the intended purpose for a device and will also deter- mine the risk class (Class I–III, or Class 1–4 for in vitro diagnostic devices), having regard to whether the device is powered and the body system involved. Often, products do not neatly correspond to one cate- gory, and will depend on therapeutic claims made and the scientific evidence for the how the product works. Boundary or combination products will be classified according to their principal therapeutic effect. A num- ber of legislative instruments also declare or deter- mine certain products to be therapeutic goods, or to be excluded from the application of the therapeutic goods regime. 3.2 Marketing Authorisation for Biologic Medicinal Products In Australia, biological medicines (eg, monoclonal antibodies, vaccines, gene therapies) follow the same registration pathway as other prescription medicines on the ARTG. There is no separate biologics licence in Australia. At a practical level, manufacturing and quality (CMC) data for biologicals may face height- ened scrutiny as biologicals are produced from living systems and are generally more variable than conven- tional chemical drugs. 3.3 Period of Validity of Marketing Authorisations In Australia, ARTG entries for medicines and medi- cal devices do not expire, and an entry remains valid indefinitely, provided the sponsor continues to meet its ongoing obligations (namely, payment of annual charges where applicable) and the product is not otherwise cancelled or suspended from the ARTG.
3. Marketing Authorisations 3.1 Product Classification
Classification in Australia turns on the principal intended action of the product. If a product works by pharmacological, immunological or metabolic means, it is a medicine; if it works by physical means, it is a medical device. Biologicals (products derived from human cells/tissues) are classified by what they are made from, not how they work.
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