Regulatory Focus™ > News Articles > 7 > Erleada Gains First Approval Under New TGA Work Sharing Pilot

Erleada Gains First Approval Under New TGA Work Sharing Pilot

Posted 05 July 2018 | By Ana Mulero 

Erleada Gains First Approval Under New TGA Work Sharing Pilot

Australia’s Therapeutic Goods Administration (TGA) announced Thursday Janssen’s Erleada (apalutamide) became the first medicine evaluated via a new work-sharing pilot with Canada, Singapore and Switzerland regulators to be registered in the Australian Register of Therapeutic Goods.
 
The pilot—launched in April—is aimed at reducing the workload on the regulators and industry.
 
TGA worked in collaboration with Health Canada throughout the review process under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium's new chemical entities pilot.
 
Each regulator evaluated different parts of the Erleada submission and made independent decisions prior to granting clearance for the treatment for prostate cancer in both Australia and Canada.
 
Erleada was also evaluated using TGA’s priority review pathway, which was initiated in June 2017 to formalize expedited reviews of drugs for patients with unmet needs and serious conditions.
 
Janssen’s drug was approved in the US in February as the first treatment for non-metastatic prostate cancer.

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe