AUSTRALIA Law and Practice Contributed by: Greg Williams and Sheena McKie, Clayton Utz
Priority Review This is available for medicines addressing serious conditions with unmet clinical need. It reduces the evaluation timeframe to 150 working days (versus the standard 255-working-day timeframe). Provisional Registration This allows time-limited approval (up to two years, which may be extended to six) based on preliminary clinical data where the medicine shows promise for treating a serious condition. The sponsor must submit confirmatory data during the provisional period. Provisional Determination This is the equivalent fast-track pathway to the provi- sional registration pathway, but for biologicals (human cell/tissue products). Comparable Overseas Regulator (COR) Pathways Where a medicine is already approved by a recognised regulator (eg, FDA, EMA, Health Canada, MHRA), the TGA can rely on that assessment, reducing the evalu- ation to 175 working days. Applications for inclusion of a medical device that rely on assessments complet- ed by overseas regulators will also shorten the time needed by the TGA to make its decision (evidence requirements are identified in the Therapeutic Goods (Medical Devices – Information that Must Accompany Application for Inclusion) Determination 2018 (Cth)). Orphan Drug Designation This is for medicines that treat rare diseases (fewer than 2,000 Australians per year). It provides fee waiv- ers rather than a shorter timeline, but can be com- Australia is an active adopter of regulatory reliance. The TGA maintains a formal list of Comparable Over- seas Regulators (CORs), which currently includes the FDA, EMA, Health Canada, the MHRA, Swissmedic and Singapore HSA. The regulatory reliance regime in Australia operates as follows: bined with priority review. 4.2 Regulatory Reliance • for medicines, the COR pathway reduces evalua- tion from 255 to 175 working days, and the TGA can leverage the overseas regulator’s clinical and
quality assessments rather than duplicating them entirely; and • for medical devices, the TGA accepts conform- ity assessment evidence from COR jurisdictions, which can substantially shorten the ARTG inclusion process. Australia also participates in the Australia-Canada- Singapore-Switzerland-UK (Access) Consortium, which enables work-sharing arrangements on new medicine evaluations, meaning that multiple regula- tors assess different components of the same dossier collaboratively. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants All manufacturers of therapeutic goods must hold a TGA manufacturing licence if manufacturing in Aus- tralia. Manufacturers will be required to comply with Good Manufacturing Practice (GMP) standards, and a licence will be granted following a GMP inspection of the site by the TGA. TGA manufacturing licences are granted for a maximum of five years and must be renewed before expiry. The TGA conducts periodic re-inspections (typically every two to three years) to confirm ongoing GMP compliance. Overseas manufacturers can obtain GMP clearance or certification. Australia also has mutual recognition agreements with certain regulatory authorities within Europe, the UK, Canada, Singapore and New Zealand that allow mutual recognition of GMP inspection out- comes of medicine manufacturers within their borders. The TGA also has (non-binding) Memorandums of Understanding with Health Canada and Swissmedic and co-operative agreements (written understanding) with the US FDA and the European Directorate for the Quality of Medicines, which facilitate information- sharing. The TGA can suspend or revoke a manufacturing licence or GMP clearance at any time if it identifies serious non-compliance, which effectively prevents supply of all products manufactured at that site.
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