Australia and Canada forge links to regulate medicines

On 16 March 2005, the governments of Australia and Canada signed a bilateral treaty, the Australia-Canada Mutual Recognition Agreement (MRA) on Medicines Good Manufacturing Practice (GMP). The MRA was signed by the Australian Government's Parliamentary Secretary for Health, Christopher Pyne, and the Acting High Commissioner for Canada, Gaston Barban.

The MRA allows each party to recognise the other's GMP assessments about the safety and quality of new pharmaceuticals seeking to enter their respective markets. It strengthens the previous agency level Pharmaceutical Inspection Cooperation Scheme (PIC/S) agreement, which established minimum standards internationally for the inspection of manufacturing principles. This MRA allows the manufacturer's batch certifications to be recognised by the other party without re-analysis at the point of import. By reducing regulatory costs and duplication, the MRA will enhance the competitiveness of both Australian and Canadian exports by significantly speeding up the process of getting life saving drugs onto the markets of both countries. The treaty enhances bilateral regulatory cooperation, while allowing each country to maintain its own standards to preserve public health and safety.

The MRA was the result of three years of productive interchange and collaboration between the TGA and the HFPB. Other examples of the close collaboration between the TGA and the HPFB are a Memorandum of Understanding (MOU) to enhance information sharing and facilitate cooperation on the regulation of therapeutic products for human use, signed in April 2004, and the development of an MOU on medical devices quality systems certification to be implemented prior to the establishment of the joint Trans Tasman agency.

Mr Slater, Mr Schneemann, Mr Pyne, Mr Barban
and Ms Gorman after the signing ceremony

The ceremony at Parliament House was attended by about forty Canadian and Australian government and Australian industry representatives. Mr Terry Slater, National Manager, Therapeutic Goods Administration (TGA), officiated as the Master of Ceremonies while his Canadian equivalent, Ms Diane Gorman, Assistant Deputy Minister, Health Products and Food Branch (HPFB), Health Canada, made the closing remarks.

At the ceremony Mr Pyne said GMP regulation is the cornerstone of ensuring that medicines that reach the market have been manufactured at the highest standard and are safe and effective. He went on to say that "Australia is particularly pleased to enter into such an agreement with Canada which offers the prospect that both countries will have access to the latest products, which have been assessed for safety and quality to current world's best regulatory standards, in as short as possible timeframe."

Acting High Commissioner Barban said the Treaty underscored the growing trading relationship between Canada and Australia which recently surpassed $3.3 billion.

"The Treaty demonstrates the significant growth in pharmaceutical exports. It also highlights the longstanding trading relationship between Canada and Australia, which began more than a century ago, and continues to grow," Mr Barban said.

Mr Kieran Schneemann, CEO of Medicines Australia, speaking on behalf of the Australian pharmaceutical industry, congratulated the Australian and Canadian governments on a historic achievement that will streamline the approval process in both countries and is welcomed by the industry in Australia. Mr Schneemann emphasised that this treaty is a strong vote of confidence in the TGA and contributes to the high regard felt for the TGA in Canada, the USA, Europe and South East Asia.