MOU between the TGA and Swissmedic

On 221 July 2006, Australia's Therapeutic Goods Administration (TGA) and Switzerland's Swissmedic, 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 M¨hlethaler, 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 Harmonization 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.

A copy of the MOU is available on the TGA Internet site <http://www.tga.gov.au/international/mou_switzerland.htm>.