Australia’s TGA Releases 2013-2015 International Engagement Strategy

| 01 August 2013 |  By 

Australia's Therapeutic Goods Administration has released an outline of its goals in the international arena for the next three years.  The International Engagement Strategy 2013-2015 links current Australian priorities for international engagement that are necessary to support effective therapeutic goods regulation with the TGA's day-to-day activities and sets clear goals for international engagement activities.

Those activities include:

  • Driving regulatory harmonization to reduce duplication and improve efficiency and effectiveness in premarket and postmarket evaluation of therapeutic goods
  • Development of the joint Australia and New Zealand Therapeutic Products Agency (ANZTPA)
  • Ensuring the integrity of supply chains and overseas manufacturers' compliance with manufacturing standards
  • Contributing to the delivery of Australia's global and regional public health responsibilities
  • Improving mechanisms for exchanging information
  • Building greater regulatory capacity in the Asia Pacific region
  • Maximizing the value of international activities

TGA stresses that achieving these goals will require strategic and coordinated investment in terms of resources, harmonization projects, attending international meetings, and greater reliance on the expertise and resourcing opportunities available throughout the government.  At the same time, the agency also recognizes possible obstacles to the effective delivery and implementation of activities under its International Engagement Strategy, such as differences in international regulatory approach, failure to agree common international standards, inability to share unredacted information between regulators, and limited access to post-market monitoring information, as well as the agency's own Blueprint reform agenda and workload for the establishment of ANZTPA.

TGA Report

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Tags: australia

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