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Two top regulators in information exchange.

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THE HON CHRISTOPHER PYNE MP Parliamentary Secretary to the Minister for Health and Ageing

Parliament House Canberra ACT 2600 • Telephone: (02) 6277 4842 Facsimile: (02) 6277 8581

29 March 2006 CP15/06

Two top regulators in information exchange

Two of the world’s most respected therapeutic products regulators, Australia’s Therapeutic Goods Administration (TGA) and Switzerland’s Swissmedic, have today signed a Memorandum of Understanding (MoU) formalising their cooperative arrangements to exchange information about regulatory decisions and post-market monitoring of therapeutic products.

Australia’s Parliamentary Secretary for Health, Christopher Pyne, and Switzerland’s Ambassador to Australia, Mr Christian Mühlethaler, signed an MoU that provides a more formal framework for information sharing, particularly around regulatory decision-making in areas of medicines Good Manufacturing Practice (GMP) inspections, complementary medicines and the global device vigilance exchange program.

“Both countries already have strong regulatory programs for medicines and medical devices,” Mr Pyne said.

Swissmedic and the TGA have developed a strong relationship over the years, particularly in areas of medicines GMP inspections through membership of the Pharmaceutical Inspection Co-operation Scheme, and in medical devices through membership of the Global Harmonisation Task Force for medical devices.

The MoU will facilitate the exchange of information and documentation about the regulation of all therapeutic products, and encourage developing collaborative activities and sharing of information about the regulation of medicines and medical devices.

“The TGA has entered into several international agreements, including mutual recognition agreements with Singapore, Canada and the European Union. As well, MoUs have been signed with the US Food and Drug Administration, Health Canada and the regulatory agencies of Indonesia and Thailand. We are pleased to now enter into an MoU with Switzerland, which is highly regarded internationally as a therapeutic goods regulator,” Mr Pyne said.

Media contact: Adam Howard, Mr Pyne’s Office, 0400 414 833 Kay McNiece, TGA, 0412 132 585