International work-sharing pilot - Apalutamide (Erlyand)
Apalutamide (Erlyand®) is the first medicine to be registered on the Australian Register of Therapeutic Goods (ARTG) that has been evaluated under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium's New Chemical Entities Work Sharing Pilot. The review also utilised TGA's new Priority review pathway.
Efficiencies were achieved through the work-sharing of the evaluation between Health Canada and the Therapeutic Goods Administration, with each regulator taking a lead in the evaluation of different parts of the regulatory submission dossier. However, each regulator made independent decisions regarding approval (market authorisation) of the new medicine.
Apalutamide will be sold under the name Erlyand® in Australia and Erleada® in Canada, and is indicated for the treatment of prostate cancer, thus expanding treatment options for patients in both countries.
The Work Sharing pilot strengthens our international partnerships in submission review and facilitates prompt review and approval of new medicines, providing better health outcomes for all Australians.
For more information on this Work Sharing pilot please see ACSS - NCE work-sharing pilot.