REGULATORS IN AUSTRALIA, CANADA ANNOUNCE JOINT REVIEW PROJECT

Australia's Therapeutic Goods Administration (TGA) and Canada's Biologics and Genetic Therapies Directorate (BGTD) have announced a joint project, the Parallel Review Project, which aims to enhance cooperation between the regulators.

The purpose of the project is to provide a mechanism for sharing information on biologic drug review between the BGTD and TGA. The intent is to use the parallel review pilot project as a confidence-building exercise in which both organizations will share information about their review and decisionmaking practices. The project will involve reviewing one or more submissions in parallel.

The TGA has posted on its website a list of requirements for sponsors to facilitate the project, which include: four to six weeks of notice to the regulators of a planned biologic submission; simultaneous filing of submissions in both jurisdictions; willingness to participate in a pre-submission meeting with both regulators; and payment of fees and charges applicable in each jurisdiction.