Posted by Michael Wonder on 10 Jul 2018
Medicines Australia welcomes priority review pathway programme milestone
10 July 2018 - Last week saw the listing of Eryland (apalutamide) for the treatment men with non-metastatic (castration-resistant) prostate cancer.
As part of the implementation of recommendations from the Review of Medicines and Medical Devices Regulation (MMDR) the TGA has introduced a priority review pathway designed to speed up the review and approval of certain medicines. This joins many other countries in meeting regulatory best practice to ensure that Australian patients can get access to the medicines they need, when they need them.
The evaluation of Eryland included a unique joint initiative between Australian and Canadian Health regulators which saw the evaluation process completed in less than half the time it normally takes for a new medicine to be approved in Australia.
