TGA international engagement strategy 2016-2020

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13 December 2016

Appendix

TGA’s engagement with international regulatory initiatives and agencies

The TGA has active involvement in many international initiatives and working relationships with several overseas regulators. These collaborations keep TGA well-informed about post-market monitoring of therapeutic goods and ensuring the regulatory framework meets international best practice. The TGA works collaboratively with other overseas regulators on various projects and also has formal collaborative arrangements in place with a number of other regulators.

Details of some of the international regulatory initiatives and agencies with whom the TGA regularly engages include:

Name Engagement
Australia - Canada - Singapore - Switzerland (ACSS) Consortium

The ACSS Consortium comprises Australia, Health Canada, Health Sciences Authority of Singapore, and Swissmedic, the Swiss Agency for Therapeutic Products. The TGA is the Reference Regulatory Agency for the first work sharing trial underway in the Generics working group. TGA is also represented on the following working groups under the Consortium:

  • Complementary Health Products
  • New Chemical Entity
  • IT
  • Post Market.

https://www.tga.gov.au/australia-canada-singapore-switzerland-acss-consortium

Asia Pacific Leaders Malaria Alliance (APLMA) The Australian Department of Health, through the TGA, is a member of APLMA – which is an affiliation of Asian and Pacific heads of government formed to accelerate progress against malaria and to eliminate it in the region by 2030.

http://aplma.org/about#sthash.wsaCcAxI.dpuf

Centre for Innovation and Regulatory Science (CIRS) The CIRS is an independent regulatory science organisation conducting novel research, convening international forums for healthcare stakeholders and conducts its own research and data on comparative performance of regulators to advance global regulatory and Health Technology Assessment policies and enhance patient access to medicines. The TGA is a participating regulatory authority with the CIRS, and also sits on their Scientific Advisory Council.

http://www.cirsci.org/

European Directorate for the Quality of Medicines and HealthCare (EDQM) The EDQM protects public health by enabling the development, implementation and monitoring the application of quality standards for safe medicines and their safe use. The certification procedure for the European Pharmacopoeia involves assessment of the suitability of monographs to control the chemical purity, microbiological quality and transmissible spongiform encephalopathy (TSE) risk (if relevant) for any substance covered by a European Pharmacopoeia monograph.

Australia is one of the countries (outside of European member states) that recognises the Certification Procedure for the European Pharmacopoeia in its evaluation processes for generic medicines, and provides technical reviewers each year to the certification process.

International Coalition of Medicines Regulatory Authorities (ICMRA) The ICMRA is a voluntary, executive-level, strategic coordinating, advocacy and leadership entity of regulatory authorities. ICMRA aims to provide a global architecture to support enhanced communication, information sharing, crisis response and address regulatory science issues. ICMRA currently comprises over 20 of the world’s major medicine regulatory authorities, as well as WHO. The TGA represents Australia as a participating regulatory authority on the ICMRA and is currently (2017-2018) a vice chair of ICMRA. ICMRA is progressing a number of strategic priority projects including Pharmacovigilance for which TGA is project lead.

http://www.icmra.info/index.html#a_aboutus

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) The ICMRA is a voluntary, executive-level, strategic coordinating, advocacy and leadership entity of regulatory authorities. ICMRA aims to provide a global architecture to support enhanced communication, information sharing, crisis response and address regulatory science issues. ICMRA currently comprises over 20 of the world’s major medicine regulatory authorities, as well as WHO. The TGA represents Australia as a participating regulatory authority on the ICMRA and is currently (2017-2018) a vice chair of ICMRA. ICMRA is progressing a number of strategic priority projects including Pharmacovigilance for which TGA is project lead.

http://www.ich.org/home.html

International Generic Drug Regulators Programme (IGDRP) The IGDRP was created to promote collaboration and convergence in generic drug regulatory programs in order to address the challenges posed by increasing workloads, globalisation and complexity of scientific issues. The TGA is a member of the Steering Committee of the IGDRP and participates in all the working groups. The TGA also established and maintains the IGDRP website, and currently acts as IGDRP Secretariat.

http://www.igdrp.com/

International Medical Devices Regulators Forum (IMDRF) The IGDRP was created to promote collaboration and convergence in generic drug regulatory programs in order to address the challenges posed by increasing workloads, globalisation and complexity of scientific issues. The TGA is a member of the Steering Committee of the IGDRP and participates in all the working groups. The TGA also established and maintains the IGDRP website, and currently acts as IGDRP Secretariat.

http://www.imdrf.org/index.asp; http://www.fda.gov/medicaldevices/internationalprograms/mdsappilot/default.htm

International Pharmaceutical Regulators Forum (IPRF)

The IPRF creates an environment for pharmaceutical regulators to exchange information to:

  • maximise potential efficiencies in addressing the increasingly complex global context of medicines regulation
  • facilitate the implementation of ICH and other internationally harmonised technical guidelines for pharmaceuticals for human use
  • contribute to the coordination of a range of international efforts related to regulation of medicines.

The TGA represents Australia in the IPRF working groups.

https://www.i-p-r-f.org/index.php/en/iprf-network/mandate/

International Society of Pharmacovigilance (ISOP)

The ISOP is a professional, independent and non-profit society that aims to foster pharmacovigilance both scientifically and educationally, and enhance all aspects of the safe and proper use of medicines, in all countries. Australia is a member of the ISOP.

http://isoponline.org/about-isop/

International Organisation for Standardisation (ISO)

The ISO is a major international standard-setting body for the manufacture and design of medical devices. The TGA uses these standards as assessment criteria and TGA officers participate in their development. Australia is a member of the ISO.

http://www.iso.org/iso/home.html

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme ( jointly referred to as PIC/S)

PIC/S develop international standards between countries and pharmaceutical inspection authorities, to provide harmonised and constructive co-operation in the field of GMP. PIC/S’ mission is: to lead the international development, implementation and maintenance of harmonised Good Manufacturing Practice (GMP) standards and quality systems of inspectorates in the field of medicinal products. The TGA is a member of the PIC/S.

https://www.picscheme.org/

Regulatory Cooperation Initiative (RCI)

Between Health Canada and Australia

The RCI is a work sharing project between Health Canada (Health Products and Food Branch) and Australia (TGA) in order to pursue the elimination of duplication of effort, where possible. Key areas identified as areas of focus for the project include: generic medicines; medicine manufacturing site inspections – GMP inspections; new chemical entities, over-the-counter medicines and post-market surveillance.

World Health Organization (WHO)

The WHO works with countries to promote affordable access to quality, safe and effective medicines, vaccines, diagnostics and other medical devices. It promotes policies and technical capacities in low-resourced health systems, develops international standards for the manufacturing and regulation of health products and provides guidance for health systems everywhere to deliver them safely and cost-effectively. Australia is a founding member of the WHO.

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