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TGA international engagement strategy 2016-2020

13 December 2016

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Goal 1: Contributing to public health and safety through regulation

Why is this important?

The TGA regulates the import, supply, export, manufacture and advertising of therapeutic goods including medicines, medical devices and biologicals. Since most therapeutic goods originate overseas, it is important that the TGA contributes to international efforts to support the safety, effectiveness and quality of these products.

International engagement helps the TGA maintain an effective regulatory framework that is contemporary and consistent with international best practice. It also assists with proactive post-market monitoring and management of emerging safety and performance issues with particular medicines and medical devices, and staying up-to-date with relevant international standards and conventions.

What are we doing?

The TGA contributes through active engagement in international regulatory initiatives including:

  • the International Coalition of Medicines Regulatory Authorities (ICMRA)
  • the Heads of Agencies (Australia, Canada, Singapore, and Switzerland (ACSS)) Consortium
  • the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) at which the TGA is a formal observer
  • the World Health Organization (WHO) and
  • the International Medical Devices Regulators Forum (IMDRF).

A comprehensive list of TGA’s engagement with international regulatory initiatives and agencies is listed in the Appendix.

Case Study

TGA’s involvement in the WHO Collaborating Centre for Drug Quality Assurance

The WHO Collaborating Centre forms part of the collaborative network set up by the WHO in support of its policies and programs. In this role, the TGA:

  • provides support to the WHO’s program, The International Pharmacopoeia, including development and validation of test methods for medicines
  • performs quality assurance testing of medicines
  • provides scientific advice on quality assurance of medicines
  • provides training of laboratory personnel in the validation and application of analytical procedures in the quality assurance of medicines.

We are regularly called upon to provide training and share expertise with other regulators, particularly those with developing regulatory systems in the Western Pacific Region. This arrangement strengthens Australia’s relationship with the Western Pacific Regional Office (WPRO) of the WHO, which coordinates efforts to build regulatory capacity in the region.

The TGA’s WHO Collaborating Centre for Drug Quality Assurance has a longstanding history of providing support to the WHO’s program, The International Pharmacopoeia. The International Pharmacopoeia provides a key source of pharmaceutical standards for developing countries and regions around the world, including the Western Pacific. The International Pharmacopoeia helps protect these countries from counterfeit/adulterated/ substandard medicines. The TGA’s Collaborating Centre assists the WHO with the development of new monographs for medicines on the WHO Model List of Essential Medicines and other priority medicines of major public health importance by providing testing and/or scientific advice.

Case Study

Improving access to medicines and tests used for diagnosis and treatment of malaria

Malaria continues to be a major source of morbidity and mortality in the Asia-Pacific region – in particular in South Asia, Mekong Countries, Indonesia and Papua New Guinea.

In 2014, the TGA was asked by the Asia-Pacific Leaders Malaria Alliance (APLMA) to coordinate preparatory meetings and author a detailed plan for how Asia-Pacific regulators could support better control and eradication of malaria. This plan forms part of the East Asia Leaders Malaria Elimination Roadmap which was endorsed by regional leaders, including the Australian Prime Minister at the November 2015 East Asia Summit.

The Roadmap priorities include a focus on actions to provide universal access to high quality prevention, testing and treatment commodities as well as the need to accelerate access to innovative products for malaria elimination. Delays in obtaining regulatory approval for critical medicines and diagnostic tests have been one of the biggest barriers to access. It is critical to develop ways to permit fast-track review and approval of new antimalarial medicines and diagnostic tools, without compromising on legal requirements and appropriate scrutiny of the products.

The APLMA Secretariat, the Department of Health through the TGA, the Asian Development Bank and the WHO are part of a new regulatory partnership between regulatory authorities in the Asia Pacific to improve the efficiency and quality of the regulatory review for new antimalarial treatments and diagnostic tests.

What should we be doing in 2016-2020?

  1. Continue to support cooperation, engage and cooperate with the WHO and regulators in comparable health systems.
  2. Continue to assist, and work with less advanced regulators in our region to strengthen their capacity.
  3. Continue to participate in international regulatory fora, maximising opportunities to improve public health and safety and maintaining our leadership role.

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