Australia‘s regulatory framework for therapeutic goods is undergoing a number of changes in response to the Review of Medicines and Medical Devices Regulation (MMDR).
The Government accepted MMDR recommendation 21 to ‘establish target timeframes that reflect international benchmarks and the typical lifecycle of a medical device’ for assessment and inclusion in the ARTG.
An independent reviewer was engaged to undertake consultation and examine how the TGA’s process and timeframes compare with international regulators.
The review report outlines the timeframes for the regulatory frameworks in Australia, the USA, Canada, Japan, Brazil and the European Union (using the UK and the Netherlands as examples). Overall, it was found that the variation between regulatory systems make comparison difficult, and Table 1 in the report provides a summary comparison across jurisdictions…