Canadian and Australian health regulators sign Memorandum of Understanding
14 April 2004
The Health Products and Food Branch (HPFB) of Health Canada and the Therapeutic Goods Administration (TGA) of Australia's Commonwealth Department of Health and Ageing signed, today, a Memorandum of Understanding aimed at information sharing and facilitating collaborative activities.
"Health Canada is very pleased to put in place a formal arrangement which sets out future steps with the Therapeutic Goods Administration," said Diane Gorman, Assistant Deputy Minister of the Health Products and Food Branch of Health Canada. "The Health Products and Food Branch has worked with the TGA on a number of issues, and the level of collaboration, information sharing and understanding between our two organizations has allowed for a productive and positive relationship."
Mr Terry Slater, the National Manager of Australia's TGA said "the MOU with Canada would give rise to improved and faster decision making and reduce costs to industry in both countries, while giving greater confidence to consumers about the quality, safety and efficacy of the products on their respective markets."
The MOU will facilitate cooperative activity between Canada and Australia, specifically in the area of information sharing related to therapeutic products for human use. Shared information on these products will include review and evaluation of investigational and marketing applications; manufacturing establishment compliance; and, post-marketing surveillance activities.
HPFB and TGA will share information regarding clinical trials or marketing applications for therapeutic products, product testing for biological products, and compliance and enforcement activities, among other issues and topics of mutual relevance. Both HPFB and TGA will ensure confidential information is protected as necessary, while using that information as a tool to work toward the overall objective of contributing to the health and safety of Canadians and Australians.
The MOU, signed by Diane Gorman, Assistant Deputy Minister of the Health Products and Food Branch, and Terry Slater, National Manager of the Therapeutic Goods Administration, takes effect immediately. Canada and Australia will review the MOU after one year of operation to ensure that it is achieving its mandate of contributing to the health and safety of Canadians and Australians.