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Delivering reforms - Implementation plan for TGA Reforms: A blueprint for TGA's future

16 July 2012

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Executive summary

The Therapeutic Goods Administration is implementing a comprehensive package of reforms drawn together by the Australian Government and announced in December 2011 in the TGA reforms: A blueprint for TGA's future (the Blueprint).

The Blueprint reforms aim to improve community understanding of the TGA's regulatory processes and decisions, and enhance public trust and confidence in the safety and quality of therapeutic goods. In particular, the reforms aim to improve understanding of the role that the TGA plays in ensuring that Australians have timely access to the therapeutic goods that they need, and that these goods meet appropriate standards of quality, safety and efficacy.

The reforms also aim to ensure that the regulatory framework for therapeutic goods can be adapted to scientific developments and emerging community expectations about therapeutic goods.

This document provides an overview of the TGA's planned actions in response to the Blueprint reforms and how it will report on its progress in achieving the required outcomes.

Throughout the implementation of the Blueprint reforms, the TGA will consult with the Australian Therapeutic Goods Advisory Council and will take account of feedback from stakeholders.

The TGA is also committed to working collaboratively with its external stakeholders—consumers, health professionals and industry—to ensure the Blueprint reforms are implemented effectively, and that stronger relationships are established for the future.

The Blueprint reforms are grouped into the following key themes:

  • communication and stakeholder engagement;
  • advertising of therapeutic products;
  • complementary medicines;
  • medical devices; and
  • promotion of therapeutic products.

Reform in each of these areas will be achieved incrementally over four years, in three phases. The priorities are:

  • better managing our communication;
  • better managing our practice; and
  • mature and sustainable performance.

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