International Coalition of Medicines Regulatory Authorities (ICMRA)

The International Coalition of Medicines Regulatory Authorities (ICMRA) brings together the heads of 30 medicines regulatory authorities from every region in the world, with the World Health Organisation (WHO) as an observer.

The head of TGA is the Vice-Chair of ICMRA and TGA representatives are actively engaged in the work of enhancing international regulatory collaboration, improving communication, and addressing shared regulatory challenges.

ICMRA members

The full name of each regulatory authority can be found in latest ICMRA membership list.

ICMRA projects

Current ICMRA projects include:

• 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
• Pharmacovigilance
  • Working on real world evidence (big data), adverse event reporting and vaccine confidence
• Public health response
  • During the COVID-19 pandemic, ICMRA is acting as a forum to support strategic coordination to expedite and streamline the development, authorisation and availability of COVID-19 treatments and vaccines worldwide.
• Supply chain integrity
  • Publication of Recommendations on common technical denominators for track and trace systems to allow for interoperability (pdf,1.57Mb)

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 aim of the workshops, subgroups and working groups are to streamline the development, authorisation and availability of COVID-19 treatments and vaccines worldwide.

In August 2020, TGA and MHRA established and continue to co-chair the ICMRA COVID-19 Vaccines Pharmacovigilance Network, which meets regularly to share knowledge, experience and communications on pharmacovigilance activities and the emerging benefit-risk profile of COVID-19 vaccines.

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. ICMRA members and the WHO issued a joint statement: How COVID-19 vaccines are regulated for safety and effectiveness, to inform and help healthcare professionals answer questions about the role of regulators in the oversight of COVID-19 vaccines. It explains how vaccines undergo robust scientific evaluation to determine their safety, efficacy and quality and how safety will continue to be closely monitored after approval.

Contact ICMRA

The ICMRA Secretariat sits with the Chair of ICMRA, currently the Head of EMA, and can be contacted at: ICMRAcoordination@ema.europa.au.

Australian representatives to ICMRA can be contacted through the TGA at: ICMRA_TGA@health.gov.au.