Australia and Canada Jointly Approve Breast Cancer Drug

Regulatory NewsRegulatory News | 18 April 2019 |  By 

As part of a push toward regulatory convergence, Health Canada and Australia’s Therapeutic Goods Administration (TGA) last week jointly approved Eli Lilly’s Verzenio (abemaciclib) for the treatment of metastatic breast cancer.

Each regulator evaluated different parts of the regulatory submission dossier, although both made independent decisions regarding approval. Health Canada also worked with the Canadian Agency for Drugs and Technologies in Health (CADTH) on the approval to reduce the time between approval and a government funding decision.

The joint Australia-Canada approval is part of ongoing work among a consortium of regulators, known as the Australia-Canada-Singapore-Switzerland (ACSS) Consortium, including the TGA, Health Canada, Singapore's Health Sciences Authority and Switzerland’s Agency for Therapeutic Products.

The regulators’ partnerships bring together smaller markets to create a larger population that might make a drug submission more attractive to file when compared to the individual countries alone.

Verzenio’s approval is the second time Health Canada and the TGA have worked together to approve a drug, with the first coming in July 2018 for Janssen’s apalutamide, which is sold under the brand name Erlyand in Australia and Erleada in Canada.

“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,” Health Canada said.

The ACSS Consortium’s New Chemical Entities (NCE) Working Group pilot is initially focusing on common submissions between Health Canada and TGA.

In general, each regulator will evaluate their respective Module 1, Health Canada and TGA will evaluate Module 3 (Quality) and Module 4 (Toxicology), respectively, and both regulators will separately evaluate Module 5 (Clinical). With experience, TGA says the pilot will look to extend work-sharing opportunities to include Singapore and Switzerland.


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