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  • Regulatory NewsRegulatory News

    Australia and Canada Jointly Approve Breast Cancer Drug

    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 appr...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Australia, Singapore Expand Generic Drug Work-Sharing Trial (12 December 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Australia, Singapore Expand Generic Drug Work-Sharing Trial A regulatory consortium featuring Australia and Singapore has expanded its generic medicine work-sharing program. The initiative allows companies to file for approval with multiple agencies, which then perform a coordinated assessment of the application before reaching individual decisions. Agencies in Aust...