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Cooperative arrangement between Australia and the United States of America

November 2007

The TGA is delighted to announce that it has finalised a new five year cooperative arrangement with United States Food and Drug Administration (US FDA). The final stages of this important cooperative arrangement were completed during the recent visit to the TGA by Dr Murray Lumpkin, Deputy Commissioner US FDA.

The TGA and the US FDA have a long history of regulatory cooperation. This is particularly important in an era where the globalisation in the manufacture of human pharmaceutical products presents common challenges and opportunities for national therapeutic product regulators to explore cooperative arrangements.

This cooperative arrangement will significantly enhance information exchange between the TGA and the US FDA. It will facilitate more efficient regulation and information exchange in many areas including:

  • sharing information about prospective inspection schedules, particularly in relation to inspections of manufacturers in other countries
  • inspection outcomes and prospective inspection schedules
  • sharing Good Manufacturing Practice information from manufacturers located in other countries
  • providing information on TGA audits of US complementary medicine manufacturers who export to Australia
  • the FDA providing, upon request, the TGA with Establishment Inspection Reports. This would be reciprocated by the TGA
  • inspection information or official test results about a potential health hazard, recalls, and market withdrawals
  • sharing remote access to a computerised database summarising site-specific information, such as legal status, location, operations, and inspection dates, or any database similar to COMSTAT that contains recall data, inspectional data, refusal information, and analytical data supporting an import alert, and
  • information on firms that potentially counterfeit or substitute Active Pharmaceutical Ingredients.

All sharing of information between the FDA and TGA under this new arrangement, and the treatment of received information, will be conducted in accordance with a pre-existing Confidentiality Commitment between the agencies signed on 11 August 2004.