Medicines Australia welcomes priority review pathway programme milestone.
Last week saw the listing of ERLYAND® (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 ERLYAND® 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.
The collaborative pathway provides a predictable and transparent mechanism to formalise the expedited process for sponsors of new medicines and is indicative of the Government’s genuine commitment to accelerating approval of new, innovative therapies for Australian patients.
The TGA and Department of Health have shown a long-standing commitment to ongoing policy reforms.
Medicines Australia congratulates both Departments on their quest to modernise their process through flexibility and updated processes, thus providing rapid access to new medicines for Australians.
The success of this first priority review marks another significant milestone of the MMDR, which identified ways to improve access to therapeutic goods for patients and remove unnecessary red-tape for industry whilst maintaining the safety of therapeutic goods in Australia.
A number of these reforms required legislation and the TGA, the Department of Health and both sides of Parliament have worked collaboratively and constructively to ensure that the legislature was drafted and passed efficiently.
Medicines Australia looks forward to seeing further examples of how the priority review pathway programme can mean Australians have faster access to breakthrough medicines.
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More information – Natalie Wimmer – 0450728660 | nwimmer@medaus.com.au