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International Coalition of Medicines Regulatory Authorities (ICMRA)

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The International Coalition of Medicines Regulatory Authorities (ICMRA) is a global forum that brings together the heads of over 40 medicines regulatory authorities from all regions of the world, with the World Health Organisation (WHO) serving as an observer.

ICMRA members are united by a shared mission to safeguard public health through strategic leadership and enhanced international cooperation on common regulatory challenges. The coalition facilitates collaboration, promotes regulatory convergence, and strengthens the global response to emerging health threats.

Professor Tony Lawler, Head of the Therapeutic Goods Administration (TGA), currently serves as Chair of ICMRA following his election in October 2025.

Head of Australia’s therapeutic goods regulator appointed Chair of international regulatory coalition

TGA representatives actively contribute to ICMRA, supporting efforts to improve international regulatory collaboration, enhance communication, and address shared regulatory challenges.

ICMRA members

The full name of each regulatory authority can be found in the latest list of ICMRA Membership Country/Region and Regulatory Authority' s website.

ICMRA projects

ICMRA’s strategic initiatives are established to address the evolving landscape of global health challenges and priorities. These initiatives are dynamic in nature, launched in response to emerging needs and concluded once their objectives are achieved. A list of the current ICMRA strategic initiatives can be found below.

  • Antimicrobial Resistance (AMR)

    Developing a coordinated global approach to a multifaceted public health threat.

  • Communications

    Promoting ICMRA's strategic direction, advocacy and leadership to the global medicines regulatory community to address key regulatory challenges.

  • Drug shortages

    Working towards a global pharmaceutical knowledge management system to enhance regulatory reliance and agility.

  • Innovation

    Ongoing investigation and case studies relating to emerging regulatory challenges.

    Implementation of the ICMRA Artificial Intelligence (AI) Steering Committee, facilitating dialogue and shared knowledge regrading AI usage in drug development, regulatory tools, emerging technologies and best practices.

  • Pharmacovigilance

    Working on real world evidence (big data), adverse event reporting and vaccine confidence.

  • Real-world evidence for public health emergencies

    Provide a collaborative forum for international regulatory authorities aimed at proactively enhancing the efficiency and coordination of critical responses to emerging public health emergencies. This is achieved through joint studies, shared expertise, and the generation of robust evidence to support timely and informed decision-making.

ICMRA's role during the COVID-19 pandemic

In April 2020, ICMRA members pledged to strengthen global collaborative efforts to align the facilitation of rapid development, approval and global roll-out of safe and effective medicines to prevent and treat COVID-19.

The global impact of the COVID-19 pandemic has resulted in an unprecedented level of public interest in vaccines and their development and regulatory review.

The importance of collaborative work was highlighted through this period and is the basis of our continuing work with ICMRA and other global collaborative efforts.

Contact

For all ICMRA-related enquiries, please contact the ICMRA Secretariat at: ICMRASecretariat@health.gov.au

Page history

Show all page updates (1)
  • Updated first section to reflect increase in number of ICMRA members and the election of Professor Tony Lawler to the Chair of ICMRA.
  • Updates to ICMRA projects.
  • Contact details added. 
  • Updated first section to reflect increase in number of ICMRA members and the election of Professor Tony Lawler to the Chair of ICMRA.
  • Updates to ICMRA projects.
  • Contact details added.