Australia Canada Singapore Switzerland (ACSS) Consortium – Erleada approval

July 13, 2018
Our file number: 18-108470-709

On July 4, 2018 Health Canada approved the first drug to be evaluated under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium’s New Chemical Entities Work Sharing Trial. The Work Sharing Trial is an initiative under the “Regulatory Review of Drugs and Devices” and is aimed at strengthening our international partnerships in submission review and enabling a prompt authorization of the drug product to allow Canadians to have faster access to the medicines they need.

This pilot drug submission was jointly reviewed by Health Canada (HC) and the Therapeutic Goods Administration (TGA). The new drug, apalutamide, will be sold under the name ERLYAND in Australia and ERLEADA in Canada and is for the treatment of prostate cancer. In both countries, this drug submission was reviewed on a priority basis for a type of prostate cancer that currently has limited treatment options.

For this joint review, efficiencies were achieved through the division of the evaluation tasks between the two regulators. Each regulator evaluated their respective country-specific information and clinical data, while HC evaluated the quality data and the TGA evaluated the toxicology data. This joint assessment focussed only on the evaluation phase, with each regulator making an independent decision regarding market authorisation. The sharing of work between the two regulators has provided valuable knowledge and experience which will help facilitate future joint reviews between the ACSS members as we continue this important initiative.

This is a truly unique global collaboration between regulatory authorities and the pharmaceutical industry. The potential gains from this initiative include a reduction in regulatory burden (e.g., with the filing of common dossiers), the potential for similar market authorisation dates between regions and consolidated questions to applicants.

For more information on this Work Sharing Trial please see the following links for each ACSS member.

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